Albanian Policy

7/31/2019 Albanian Policy

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National Policy or Management o Medical Devices in Albania 5

able o Contents bb v ...................................................................................... 61. duc d b ckg u d ........................................................ 71.1 Pu p P c D cum ........................................................ 71.2 c p P c D cum ............................................................ 71.3 T M d c c g C g ............................................. 82.1 M d c D v c M g m c (MDM )

M ......................................................................... 102.2 g c M d c D v c ............................................... 132.3 C c g g U (C U) ............................................... 16

3. c c uc u upp m .................................... 213.1 Gu d dv v p gm m d c d v c . ................................................................ 21

3.2 Gu d M d c d v c m m .................... 274. M d c D v c Gu d c d g p ...4.1 Gu d cqu M d c D v c ........................... 374.2 Gu d cc p c M d c D v c .................... 494.3 Gu d C c U M d c D v c ........................... 54.4 Gu d M c M d c D v c ......................... 615. c g m .................................................... 765.1 V .......................................................................................... 765.2 u z ......................................................... 76 x .............................................................................................. 79 x 1 .............................................................................................. 79T g v m w k Pub c P cu m b ...... 7

x 2 ............................................................................................... 89C ck Qu b dd d p P cu m M d c .................................................................... 89 x 3 ............................................................................................... 91

qu m c u v d x 4 ............................................................................................... 91P c du qu d P c P cu g

M d c D v c ug D ................................................... 91 x 5 .............................................................................................. 101mp M d c D v c b g d ..................................... 101

x 6 .............................................................................................. 106 dv v p g .................................................................. 106 x 7 .............................................................................................. 115

- u m u c u d p duc ..................................................... 115


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6 Ministry o ealth

AbbreviationsAER Adverse events reportingALL Albanian LekBENC Biomedical Engineering CentreBSc Bachelor of ScienceCE Clinical EngineeringCEU Clinical engineering unitsCRT Cathode ray tubesEBM Evidence based medicineEC European CommissionECB European Central BankECRI Emergency Care Research Institute,

AER reporting institution etc.EU European UnionGDP Gross domestic productHII Health Insurance InstituteHMIS Health management information systemHSR Health sector reformsICU Intensive Care UnitINSTAT Albanias National Institute of StatisticsIPH Institute of Public HealthLCC Life-cycle costs

LTHSD Long-term Strategy for the Development of the Albanian Health SystemMDD Medical Device DirectiveMDIS Medical Device Information SystemMDMS Medical Devices Management SectorMOES Ministry of Education and ScienceMoH Ministry of HealthMOLGD Ministry of Local Governments and DecentralisationSAMD State Agency of Medical DevicesNGO Non-governmental organization

NCQSA National Centre of Quality, Safetyand Accreditation of Health InstitutionsPCB Polychlorated biphenylesPHC Primary health carePHM Public health managementPPA Public Procurement AgencyPPL Public Procurement LawPRSP Poverty reduction strategy and policySAA Stabilization and Association AgreementSEK Swedish KronerSida Swedish International Development AssistanceTOR Terms of referenceTOT Training of trainersUNESCO United Nations Educational and Social CouncilUNDP United Nations Development ProgrammeWB World BankWEEE European Directive on Electrical and Electronic WasteWHO World Health Organization


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1. Introduction and background

1.1 Purpose o Policy Document

T d cum d c b c p c m g m m d c d v c b . c m g D v pm b

m ( D) d v p d b M (Md pp v d b C u c M 2004 w

b z d c g m ( ) g G v m b d u p U ( U)

2006.

2004 M d d v pm d cum w upp m d d w d

C . b pp v d b M gu 2007.

T d cum d c b c g uc u c mp c c u m d m d c d v c

b c m. v bd v pm u u g c c g m d c d v b d p c d cum , p d c p v d w b c u g d bu d c c

uc u upp d c u m d cv c . T gu d w u p g

v m w k m d c d v c .1.2 Scope o Policy Document

v c d c d b d p d w d v p c d cum d M

d d umb p c g , bu


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m d c d v c v m d - xp c c d w uf m b k-d w . v m w c

g w u v m uc u u wu xp c c c g , d

u m g f u g , u g cd f c v m d c c . T c qu d cu upp m d c c g m g m .

k d m d c d v c , v w , mu c g uc u m g d b p

qu p c du d gu d w u d v c d c duc p v v m c . g ju b u p u d v c w m d c d v

d b m c mp x d v d mu bc u c d d duc d u . T d v

g d dv c d m d c m qu u d d g c mpu , m d c pp c

d p c d m c .

D g w m d m d c c g qup c d c c g . P v d g p p m

c m d c d v c c - f c v w u g d v c g , bu m

p p v d p . T b c c p uf d du v b

c mp x d v c qu p c pm c . upp c g b qu d

x xp . T u u b mp budg c , m b g u du

-w k g qu pm dd c g xp v c . w c , p m u mp

x m m du u m d c d v c


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C mp u cc d g U m d c d v c dv p b :

d g g d B d c u c m m p c du .

d g pp c c c v g .u g dv c d p d w pp m c d v u d. w d w u d v c m m k .

f c g D c v w ug u

m .u g d v c b g C m k g w d m k .

2.1.3 Policy and strategy

P v d p , u d d p w g d p c d pc v bu d m b g d

u c u m d c d v c d b cc p d b p MDM mu

b g c mp d w k. T U mu w k c , b d p d d c p

w . c d m g m k d dv

v MDM um x cu v .

2.1.4 Scope o work

duc U g d u c C mp .. Upd gu m w k: m dm

c mp / w mu

M , d u v d b. m m d c d v c d u .

up dv v p g m ( , c.c 3.1) m d c d v c .

up uc u v : gd.M d c D v c ( MD) d C c g g U


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12 Ministry o ealth

(C U), d m u c g d f c v .D cum p c du d c cc d g m..

2.1.5 Human Resources and Competence o MDMS

m bj c v MDM p c um c mp -c d d. cu c c g g d u

m d c d v c . Bu k w dg g mp c . T w g c mp

b p d b MDM M : c c

, m d c d c , p b w b ckg u d v c , d w . w k c mp c mub bu up d u d w d d, .g w u d upp -

m d c d v c .

2.1.6 MDMS Organisation

c MDM g d w k d w gu 2-1.

Medical Devices

Management Sector State Agency of Medical Devices

Reference groups on: Adverse eventsGuidelinesStandardisation Assessment .

inistryof

Health

Clinical Engineering Unit

Figure 2-1. Proposed organizational chart for the Medical Devices Management Sector (MDMS)


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2.2 State Agency o Medical Devices

2.2.1 Introduction and Background

T B m d c g g C (B C) x g w k p m c m d c d v c .

p c u b w mm d c d v c . W c p c c gu (C U) d xp p m d c d v c ckC U, B C p B C mp

k d v u p . Up c c f mp d p

c c g g d d upp m B C.

M d c d v c m b d g b vu w . w d v c m b u d u d u z d p

p p u d du c uc ck c um b

ck m c d u c c mp c u . mp v u m d c d v c dd c mp d d. uc c mp c g d g M d c D v c ( MD). T x g B C w b

m d g c M d c D v c dp v d g v c mp c c c g

g upp m d m d c c g b C m.

T c p d c b g c M d c D v( MD), p g g v c c g gp c b b upp b w p p c g uc u m d m dd v c . MD d C U ( c p 3.2) w w k cc p w x g B C

2.2.2 Mission

p v d p , u d d p w g v p c d p mv bu d m b m u c u m d c

v c . p u k dv g pp u


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14 Ministry o ealth

m d m d c d v c c p duc d c d cf c v .

2.2.3 Policy and Strategies

MD w k w c g c mp c d c - fv g w g m v d b

p c v d upp b cm w g c mp c c c g g

T MD budg b cc mm d d w Mv budg d MD v c b c gpub c p .

2.2.4 Scope o Work o SAMD

T MD b p b :M g g M d c D v c m .

m (MD , c 3.2).M g g d b p p c g m d c d v cb.

m k d d b dv v .u g cc b m d c mmu cc.

w u p d b m d c d v cP v c c v u m d c d v cd.M d c d v c c c cc d g MDD..

m d v g dv c d .g c mmu c /c b w u p C m

m d m mb u p c m c Zd m.

up v v c mp c w qu mg. b m d c d v c w d g b

b : m k up v , d b d

m u c u , up v v c d v g dv v , g cv g ; d c d g pp c u

c m d c d v c v d puw m u c u d d b d .

p c c m m d c d v c qu m.C p c p c ..


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up d d m qu u j.m d c d v c .

2.2.5 SAMD organisation

T g c M d c D v c ( MD) w b gc M , c d b budgw b c mp d b u p c c g

w g :g mp g d b m d c d v c.

p c g m d c d v c m k c;m d v g dv c d ;b.C c v g ;c.

p c c m m d c d v c qud.m .

2.3.6 Competence

T MD d v p dv c d c mp c p cm d c d p v d u , c c gm d c d c d p cu m c w p

v c d dv c . p c c mp c qu d g c p g m d c d v c uc p cu m

d w c m c ck , v c cm c , u d d p m d c d v c .

M d c p c MD cu wv C .

u g .c c .

D g c d g .P g .

b .

c .D .


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16 Ministry o ealth

2.3 Clinical Engineering Units (CEU)


C c g g xp d d m pg m d c d v c d k d upp . T ccup

d v p d v d g du b c m m p c d d p c d. d m d c d v c

b d d b c c m c f p v p g qu pm u .

M d m d c d v c muc m c mp x. d w d g d v c c mpu b d d m d c d v c c d w c . D v c c

p b mp b , p - c v d v bug c . T qu w d g c c k

b c m d c k w dg d g d g u d d c c p k m g m c c g

p d um b d .

c c g w k w b p c c d dvk , c c b w m d c

c c g v mp c mmu c b w m d c d c g . P v d g xp p cu m , d v pm w m d , g

m , g g c p d p -p uppp v v m c m d c d v c , g c c g u d g w qu pm b g

c p k c c g . Qu d cg v u c d c ducd g c g u d d k p .

d p v d p b w c c

g g c mp c , C c g g U (C U) b b d p v .

2.3.2 Mission

T m C c g g U md v p c c d v c m d c c


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v u p d u d m m c v u p d p .

2.3.3 Policy and Strategies

C c g g U b p d wqu c mp c w g d m d c d v c w

p d c u d d g m d c dd k w g d pu c , u d c

m d c d v c .

C c g g U v xp k w dg w c m w , gu , dv c , d d d c

m d w d d dv u c u c c g d m d c d v c .

C c g g U (C U) p v d p p m d c c upp c c

p v . C c g g upp vk qu d p c pu c , cc p c ,

m c , c d d p m d c d v cpu p m d c d v c du g

u qu m : p , p d v m .

v b .

b .c m .

T C c g g U c u k b dd d .

gu .M d c p d m d .

M u c u c mm d .

2.3.4 Scope o Work o Clinical Engineering Unit (CEU)

T C U b p b :T c c m d c d v c c p.c c d p d m d c d v c c


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m p u c c d cc d g dum d u .

g v c g m d c d v c.

Box 1: Service and maintenance include: Safety control and risk management. Quality control regarding performance and func-

. Preventive maintenance.

Repair. Contacts with external companies and manage-m v c c c .

Modi cations and adaptations.

2.3.5 CEU Organisation

T C c g mp d b D c p C c g g U (C U) d p

m g C U.T M g C U mu b d c p b D

c p

2.3.6 Competence and Resources

c u c C U :f d c c g g c mp c.

c budg c ud g u c p p d b., qu pm d c c.

Competence:

C U d v d d qu d C c gbu c c ud f uc c c w k g w m d c d v c . T umb c c g c p d p d m u c mp x m d c c d d v c p p m qu d c c g g d

cc d g u p u v p g mm , w B


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20 Ministry o ealth

g g b . uc g b p m b , d c u m x d mp m

g b u v g p g mmd c mp c , m p g mm , c b c v d

m u p u v .

c c g b b xp m d cv c d c c g k w

w k w c gu v p c .

T d v pm m d c d v c d c d cg p d c g g d C U d v c mp cd v pm p w m c u u d. budg

d b d c mp c g.

T C U k xp k w dg B C dMD w pp p .

Budget and Resources: d u C U w p mp d c v c

budg d d v c db k , c mp , pp , d g. m m c d p

b c d u b d p c c uc up d v c c c d d pp p bud uc v c b c cu d w m d c d v

p cu d. T z budg u C U m c c c d p .

ools and Facility:M mum qu m c d v c qu pm

u C U:m w k p c c c d c.

p . C v c u p g d d g d p m .W k p w w kb c , c c p w , m d c g , b.d g c., p p , d qu pm

c w d k d c , d x pc., PC w c c d c p g mm

d MD w .


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3. echnical in rastructure support systems

T c g uc u u m d c d v b mu b mp v d d g

b v c . b b u m d c d v c d c w pub c d p v c mp u d d c mp uc

uc u . d d uc u pk w dg d k c g m g m m g mu b u d.

u c c d m d c d v c u c c upp m mp m d v . dv v p g m ( ) p

m b u d m u m d c d, m m k d p v cc d m c

g. m d f d p d v v p b m u c u . M d c

v c m m (MD ) v m b u d dm , g d w up c

m w m d c d v c . p u pm c , c c g d p m g m

c v c c m d c d v c . T w g c p cu d c p v upp m .

3.1 Guidelines on Adverse Event reporting system

on medical devices.3.1.1 Introduction and Background dv v w m d c d v c d d c d d/ c d c u , pc u , u xp c d u w d f c v v g

p , u p d v v u


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22 Ministry o ealth

m d c d v c . dv c d w m d c d v c m du :

c m g d g m u c u d v..

d qu uc u .b.d qu v c g d m c .c.

c d m d c dju m .d.pp p u p c c (w c m u u .d qu g).pp p m g m p c du ..

T v m w c d v c u d d.g. c c c d v c pu p ..

T c d u m g v dv c dv m c d ( .g. c m g c c ).c ( .g. d v c d g d p m

u b u c mmu mbu c ).

3.1.2 De nitions and concepts

medical device d d um , pp u , ppc , m c , w u d c

, c ud g w c p p p d d b m u c u b u d um b

pu p d g , p v , m g, m v d c mp j

d c p, c c c p . T m d c d v c , bd , d c v p c p d d c

um b d b p m c g c , mmu g c mb c m , bu m b d u c b uc m

An accessory d d c w c w b gd v c d d p c c b m u c u b g w d v c b b u d cc d

w u d v c d d b m u c u d v c ;

Blame ree culture d d m g m c g


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b c d b qu u c m. mpm u m, c c w u

pu mp v m . p u b c u g d d p d m

b m . dv v p g m c u b m mp v c g . T b m

cu u mu b c d c u g dv v p g d mp v m d c d v c d u

, d u p m p .

3.1.3 Actions to be taken by Hospital Managementb d m p c du u p m.

p g dv c d g m d c d MDM cc d c w d cum .

pp p m g (m d c d c ) c - db. p g c d d c d m

MDM w g .K p MDM m d p d c g c.

c c d .v w gu c p c du d upd cd.

3.1.4 Responsibilities

It is the responsibility o the hospital manager: d g p c du dv v p g d

c p w m d c d v c , d m kp c du k w m d c f.

It is the responsibility o the head o a clinic: p c p d c f b p g dv v . / p c p

p g, v g g d w up p d dvv d c b m cu u p g. It is the responsibility o all users o medical devices:

p dv v w m d c d v c bv v d, w d v c v c u d cc d / c

d . T dv v mu w v j p d d p .


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Box 2. Flowchart or Local Reporting o Ad-verse Events An adverse event with a medical device is discove-

d Patient is rescued and the device is taken out of

u d pu qu Te report form shall be completed by the user Te report form is sent to the head of clinic and

c d cu d m g c b . Clinic management controls that the report form

b p m g m . Hospital management completes the report and

d MDM p b Reporter (user of medical devices) and clinic ma-

g m c v c p c mp d pm p m g m

Te head of clinic take actions to prevent thev m ccu g g .

MDMS receives the report and register it MDMS consider if a complementary investiga-

b p m d, d d c p c c v d d m b u u -

v g . When appropriate MDMS informs the clinicb u w b d m c d

w m d c d v c c b p d d -k u g .

Hospital management/clinic management shallc g p c du cc d g MDM ugg -

p v v m ccu g g Te clinic management informs the sta about

c d c k c p -v cu c v


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26 Ministry o ealth

3.1.7 How to Report

T p b w g. T g c p m, c d d cum ( x 6) w c

p g. T p w u d b c c u d g. u c b

MDM b m v b .

3.1.8 How to handle de ective or contaminated items

In ected items b qu d w p bu d b p d ( - u b d pu d m u c u / upp u w g

w MDM . b d c d d b MDM b g v pp u c u v g T m u c u upp b m d p mp ,

w d p c m cc mp d b pp pp . c v g , m b p bv d m u c u w mp u u d ck m b c . w v , u dv d c b MDM , m u c u mu b w d xc g , w

m v p p duc mp c d c d w u d p jud c ub qu v g b MDM

c b d . c MDM d c d m b u d m u c u , m u c u c c d u c c m d cum

p g d.

d v c qu d u , d c v p m b m v m d c d v c c b p d. p m v d u

d uc c cum c mu b qu d d cu p d g v g . MDM dv c b ug d,

c , d c v p b c d d d kcu . p b m v d c v p w m d c d v c m u , f b m d w c d v g c d x c u du g u .

c c m d d v c , w c m c u bz d, MDM w p v d dv c w c , p


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w g m u d b m d b x m d p d c m .

W d c m /c g w u d d v d c , m b p c d p c v c mb d d p c d qu . MDM d m u c u

/ upp b c c d dv c p uc b g k .

3.2 Guidelines on Medical device in ormation system


T w g gu d d c b p c du qu v d g d m m

d v c c c u w c c m c m .

M d c D v c m m, MD , c m d c m c p g

m g c v c . m d c , c c w dm v f v

c c . W p M D , m g m d M w b b p v d c - f c

v c v c , m c d c p vp g. mp p c du w c m

p g d m g dv v v ccuw m d c d v c .

c mpu d m m m k d d g v u p d c . Tv g m bv u w u v v u d

m g d. W MD w k m

c ud v p , m v v u u g g d u d p g.

duc c mpu d MD - m u v c p g d w up

c d v c . p m p w u c v u c d c .


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28 Ministry o ealth

c d m d c d v c p w MD m u . B g m

m c p c mm d b , v mc b d d p cc d m b p v

p b u m d c d v c w k b m p g m u d w

d p k b . b kd w ccu w g v m d d v c

p , d u w m p m

d v c u p , d p v v cm b k m u u p b m . m d cv c d b w d w , b c u u d p

k u p , p b c v m d c d v c d pp p c c

mp m d. w d w c c b qu d b M m u c u .

T v w g m d p z p d c c . Bu m mum

m qu m b p c d w w kw m d c d v c w g:

v M d c D v cP v v M c d v c p g

ck g MD d c d u v c

K p g ck m d c d v c d b g b p u u c v w m d c d v c c v

c g p m d w k. W w mc d v c v c c, c c g

cc p c d m m g d v cm. w w k g d c u u upd d M d c D

v c m m c u u md v c , bu c gu pu c cum b w d v pm p u

p c m d w v m .

T m b d g d d g d uc w c b u u m d c , c c w d


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v f v u v c mf c mp u p b m m

d v c u v u c c d p . g d d c b p d m w d d

d v u d . c mpu d m m cw v v m m d c d v c , bu f w k g

m p c u p p c d gp u . T p c p g g d b w m d m u m, up p c d , c mpu .

3.2.2 Policy

c p v d w c cv m g , p d m m d c d v

c c u . T d v c p b b d c mpu d v m,

M d c D v c m m (MD ), p b c m u v m. m

g d g m d c d v c b d v p d, m d upd d m c m .T m w MD b M -MDM . Bu

MD c b pp d k p d u m.T MD c ud u w m g m dd v c m p w g d u uc

, c u d d p c m .


It is the responsibility o Ministry o Health: p v d m u qu m

, m g d d p g m d c

v c pub c c c . It is the responsibility o the State Agency o Medical Devices

(SAMD): u , m d upd MD w cum c d f u d m k

m v b v u .


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30 Ministry o ealth

d v p v g m f u qu dc umb b u d m d c d v c

b . f duc d g p p u

MD .c m d c d v c cc d c w d

d m c u .d g d upd u b ckup d

m gu b . g u z v d k p g c d

z v u . p g m d c d v c d , w v c c g g u .

It is the responsibility o the hospital manager : m m d c d v c m d v g

m d c d v c p . T gw k w MD , c ud g u d p b

b b d d d cum d c p . m u m d c d v c g

m d c d v c b c c u .

It is the responsibility o the clinical engineering unit (CEU): g b c m d c d v c d d c d b u p d m c / v c

b c d u d m b um d c d v c .

u c d g p d mc m d c d v c ccu , d d d cc b .

u g d m d c d v c m b .

It is the responsibility o the head o clinical services: u m d c d v c g

M d c D v c m m, d c d v g, c c u / c c

It is the responsibility o the user :


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u m d c d v c c v

3.2.4 Procedures and Routines

c p mu k p ck m d c d v c , mu v p c du g m d c

v c MD . T p c du b g d d d cum d d b m d v b c c g g f m m d c d v c . p c du c ub m d, v w d d upd d d u

c c , c c d pp c b .

3.2.5 Medical Devices to register in an MDIS System

m d c d v c p d/ c . c c u b g d

d w U d u d M dD v c D c v . T qu d b x 3. b w.

g u m , cc d d p b m d cb.v c b xc ud d d b g d. M d c v c p m d c d v c m b

d.T MD m c m d c d v c wc.

1995, m d c d v c w k g c d c c u .

- u p duc d d b u d um bd.c ud d m. - u m d c d v c mu

c mp w m u m u c ud v c .D v c c d d v pm b g.M d c d v c b g d du c m c v

m k g

mp .


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32 Ministry o ealth

3.2.6 Who shall register Medical Device Data

T g w k b c d u b f m c c g g u p w p c c. p w u c c g v

c m MD f. P g mcc p c g, w c c ud u c d c

m d c d v c mu b c d u . w m d cv c b d d pu v c mu bd MD p c c u . T g

b c d u m cc p c wg w m d c d v c . g c d m b u

c ck g w m d c d v c .

Box 3. De nition o medical devices

according to MDD 93/42 EC m d c d v c m um , pp u ,

pp c , m c , w u d c mb , c ud g w

c p p pp c d d b m u c u b u d um b g pu p :

- d g , p v , m g, m v d ,

- d g , m g, m , v c mp ju d c p,

- v g , p c m m d c m p g c p c ,

- c c c p , d w c d c v p c p d d c um b d b p m c g c , mmu g c

m b c m , bu w c m b d u c b uc m


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3.2.7 Classi cation o Medical Devices

M d c d v c g d m b ccc d c w d d d m c u .

m c u f d c p p d g b gu g . W m c

u c v g p -m k g g w v muc g pp u bu d up d b

u b c m g k . d m k g c v u u u u , p p g c d c

d v c , g w m k d m d , T m c u mu b c mp v d c v d v c pu m k c d d d v c g b

v , d p v d d u b c c cc d v c qu . T m c u m d d upd d c u u d m c wc c m d c d v c .

3.2.8 Unique Registration Number

c m d c d v c b m k d w u qu g umb , d v g. T g b

g d g c umb qu c . MD b pb c g umb qu c c p b g cc d g p d. T

p v g m d c d v c . w p c d v c c v m umb . T v g

b p c d c v b m d c d v c . d u . T m v

u d c v c g g .

3.2.9 In ormation to be registered

m d c d v c m m mp m b u m d c d v c b g d. M d cv c g d b g d c b v d c m c , m c

. d p c c d b u c m d c dd c d v c m d c d v c m .


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34 Ministry o ealth

c p g , p p m c mpu , c mp d v c , c ud g

M u c u upp .. umb u qu d .b.

cqu d .c. V u ( m d).d.Cu c ..P d m c d c mm d d v ..

p d m c d .g.

m d c d v c c c u b c ud d c m.T m d c d v c m b p g, p

z g d w up m c m d c d v c .C c g g U mu b u d

g p g w d w m c g g bc d u . D p u d b vc mp v . D b d b u g w d

d c w d .

v c d m c d b u c dw c c g m p m d v c

m c d d m c bu pm c . d ck c mp d p m c c m d c d v c , w g

b g d:m p w p m d p /m.

c .m p w p d p b m w m d cb.

d v c .G d c p p b m v c d.c.T p p u d du g p /m c .d.

m c mp w k b c d u b uc. d u c d d m w k cc.

c w g d p c c d v dg d.

m v c -c c d w uc v vg.m pp , c ud g v d d m


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w k c d u cc d c w g m

3.2.10 Access Rights to Medical Device Data

m u u d b MD v cc m d c d v c m m b d cumd w w c v v . p b g u d u b d cum d d b d c d d b MD c p w p m g m .

3.2.11 Removal o Medical Device Datab m d c d v c b d d p d m

d v c cc d c w Gu d D p c D v c ( c 4.5). D p d m d c d v

v v g m v d d MD mu upd d w w u d v c .M d c d v c d m m, f g c

c d .mp m b g d M d c D

m m d x 5.


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36 Ministry o ealth

4. Medical Device Guidelines or Local andRegional Hospitals

T w g gu d up c v mp p c c c m d c d v c p

g w cqu m d c d v c d w d p . T c mp c c m d c d

p c b d c b d u d gu 4-1. p d up w p c du , w

c mm d u w g gu dc c mp c dm u d g uc u d c b d c gu d . T

Gu d m d d u : Hospital management Medical device users Clinical engineers

c v g d c c g g p c c g , gu d um x c C c

g U (C U). T gu d c w v b u d b g , uc B C c , p

c u d v du w C c g g cc w x g C U v b p

EnsuringSafety and Efficiency

for the benefit of the patient

MaintenanceClinical Use

Disposal

Acquisition

Acceptancetest

Figure 4-1. Te life cycle of a medical device at hospital level


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4.1 Guidelines on Acquisition o Medical Devices


C c p cu m m d c d v c b c p m d c g uc u

d c u m d c dT mp w d d p c du

m b d gu d . m d cv c w m qu b b d w c u

p b m d c w u d d w m d p duc u .

T c d c b p cu m p c du d c c g uc u d b p

d u d c u m d c d v p v . T cqu gu d c v 5 d f

u :P cu m w m d c d v c

p p d c um b- u p duc

C g w pD

p c v g d m d cqu md v c b p cu d cc d g gu d .T c c b d duc w mc d v c d c c w uc U d c

d w p c d d c f c v u d. T gu d c dv c w cqu

p c c gu p duc d d p cqu d p p uc

g u d c c d cum u d

4.1.2 Policy

C -m k d m d c d v c d c um b b.cc p d u p .

p b p v d C -m k d m d c d v c b. g v u , - u p duc c b cc p


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38 Ministry o ealth

Bu d v c p duc d - u mu m m p cc C -m k d p duc .

w m d c d v c mu p cc p c bc. u d p .

T p cu m p c du mu c ud duc d.u d pp p c c g uc cp c m d c f d qu u u

m d c d v c p .

4.1.3 Responsibilities o Parties involved in the

Acquisition Process It is the responsibility o Hospital management.

d g p cu m p c du , g z p cd upp p c w pu c c . p -

cu m p c b d u m g m cc p d c .

It is the responsibility o Clinical management: d c m d c d d p c p

c d g d c d d p c du .

It is the responsibility o Clinical engineers: d c c c p c c , k

c mp c w MDD, c u cc p c , p p m c d d upp p c

4.1.4 Procurement o Medical Devices

T qu m mu b b d c c d . T p -cu m p c du c b d v d d v c cu v

v .

T p cu m p c du c p v m m d. c d v c w d c b g d md v c d d w cc p c . wc

p cu m m d c d v c u d gu4-2 d 4-3.M d c d mu d b u d d c b m gb.m .


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c g mc.p c c p duc qu md.

Pu c ( d p c du ). cc p c d d d c b m g m.C c g c d uppg.D v d . cc p c g d c c c.C c mp m - g u d cc p j.

p d m g m w c g v c c p .P m b c d p mk.

W .T m g m c c p b d g c c d d u g p c u d vp f c d d. C b

v mp v m p m mpc c d . W c c d ccu d

c m g mu cc p c u w pcu m p c du . T d c m g w

p b m d v c . x p c udm d v c v b m k d p

c p duc qu m . uc qu m mub b d d d u d d b m u c u

d d m b u m c c m m d c d v c d d u p c d. W

c m w d v c mu b p c d k v c cd g. p c du v u d m

b p c d. T w k c v v c mp c w k mu b g z d mu p mu b pu c d qu .

p c c cc p d b p v v d

cu m , pu c c . Pu c mu w bw, w c c J u 2007 c mp w u pd b c d b pu c c c

v .T g v m w k pub c p cu m bd c b d x 1.


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40 Ministry o ealth

W d v b ubm d m d f upp c p c w c g d g c

b w ( x 1). T c b d b mu p m k g up p c

. T w k b c c d b bj c v d p c p c w d upp . upp

d d qu . W c c cu d p m mu b c d d d c c c (

d v c c b m d. uc p m :C p v m c ..C c um b .b.C g cc p c .c.

f c ( g d u ).d.

M c c d m d p p ..c d cum u d c c m u c d

p d v c mu b v u d w d v cduc d f g mu b v u d. T

m p m b c d d c g d upp m u c u . qu m up

Replacementindicated fromMDIS (cond


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qu d mu b u d. T c c c d upm upp du g xp c d m p duc

b c d d. mp c b wupp d m u c u . T upp mu v cc

m m b u p duc m u c u , u c p v d p mp v c p duc . W u

p b c d b v u m d cc pm m g m b b d pu c c c c

b g d b pu c c .

D v d d b upp d p upp m d c p c

duc c . c ud d c c c d

g f. cc p c b p m d cc d p c du d c b d c 4.2 d cc dw c c . p b u d d m b

g m g, pp p , d w wd . cc p d d v , p m d u

w d c c . W p d c d g c c d u p .

Wanted tender arguments

Acceptance of wanted tender

Not OK

OK

Hospital management activity

Inform all suppliers

Clinical management activityDoctorsNursesClinical engineersOthers

Purchase officer Qualification of tendersList of tenders

Tender

Procurement teamTender awarding procedure

Contracting

Figure 4-3 Procurement of Medical Devices


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42 Ministry o ealth

c ck qu b dd d p p cu m m d c d v c c d d cum (

2). qu m c u vd c d ( x 3).

4.1.5 Procurement o Consumables, Accessories andSpare Parts

C um b d cc p m d c d vd b u d c mb w uc b p

c d cc d g c mm d m u c u d v c . w m u c u c mm d w d c gu d p m c

m d c d v c .

T pu c cc c mm db m u c u mu b p v d. p b mu b d d - u p duc ( 4.1.6). Wp cu g w m d c d v c , c d cc

d c um b b qu d m upp m u c u . c um b , g -u m d cc

b cc mp d b uc u , d v c p ck g v p ucc ud d w p ck g. m b g

u d d b d d u .

C um b u d g w m d c v c b C m k d b m k d w (b c

umb c d . m w xp b p cu d uc b g qu m

d g w c mp m xp m . W p cum w xp m d m upp

c ud m b u m g m u . C umb d g -u m w c v p d xpd mu b u d.

D v c b d g u d g d w b m u c u w b -u d. -u

g -u m w c mp m p


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f. upp u b d g -u m b c d d u - u p duc c b gu d

W p cu g w m d c d v c p p budg b d m c g u u d m d

d v c . c c c ( CC) b p md m c d c d p p

m d c d v c .

c mm d d p p , d c

g d g w c p p bu b m d w c c c g d c b wp m g m . P p cu g p p , u c

ub g mu v b c d u m d cd v c . p p w m c p c d bm u c u .

u b d p p b v d d u cgu d w k d c b m

u . T u u b d v p p b d m d b qu v d mu k cc u

k p d u d b u d cum d. c C -m k v u bu - u p duc

d. k mu b c d u pc d d. P cu m p p p d g

d w c mp m b p d d mu b p v d.

P cu m p p b b d- c, c p b w g g b k d w

v c . W b g v d f p m d c d v p c , v p b ,

up d d p p ck. T u qu p p m b d ck. M m u c uupp b p mp d p v d d v p p . p p d d c

M c m b d ck.

W p cu g m d c d v c d m u


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m k. T m d c p b p c m p duc m qu qu m d

b u p . T c m c ud m b xc d k d f u g d v

d qu d. C c g g c mp cd cum d v c c c . T c ud

k d cc p c c . T d cum d cum mu b d p c g d v c u d w du g w ub qu .

u - u P duc p c b qud, m d c p b p mu pp c p c b c c mm uqu . x 7 dm p d g d c mm

u p duc u d.

4.1.7 Change o Ownership

p b u d m d c d v c , w c g c c d pub c p , c u d b u

d f pub c p . uc m d c d v c m b d u m c g

cc d g U g m d c d v c c b m k u C m k g p c du b p

m d. W c g g w g g qu m b c d d d -c c c (

m b m d b cc p g m d c d v d u u m c c . mp

k p m d w m d c d v c d mc u g u p b . T p b

pp w m d c d v c m k d u c d d. uc d v c b d -

p duc d k- m w b c dB , d w p md v c , b p u d ug v g

b p c c u w g dv . x mp , w u m b

u c d u p d pu c c pp p


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46 Ministry o ealth

c c u d. T m u m qu w g d c m , f c m w

u u p b m d c d v c .

qu m M d c D v c D c(MDD) qu g m u c u p v d

m d d v w m d c d v cp c c d , p u d u

qu c m c d c b d d u d v c p p p d m

d u g d p c c , m u u d pp p c p , d c g w p mc d v c , u d v c . T m

b v b w u b c g w p b upp d w m d c d v c d v .

T g u m u u d b upp d g w m d c d v c , d u c d u m d c d v c . c mm d c

g u d b g v . T g m d c d v c m uu u d b b p v d m . m

d g m v b , m d c b c d d u u b p g w u

upd w c v b u d c m d c d vw m u c u d u d b c ud d d v . T wu u d dd u m d kup d w upd m m u c u

u u . T b c u m u c u m b ww p w m d c d v c , d w

pu m m g upd . mc d v c g b k d v c c d u d b

p d w m d c d v c d p d w uB m g b k w b p b ck mc d v c b ckw d ug u . B w

k m d c d v c c c u cc p cu d b c d u b c c g . T m d c d v

b g d M d c D v c mm d v p m c .


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4.1.8 Donation o Medical Devices

D m d c d v c d d p m c g v w d . v , d

m d c d v c d c mp w m p cd d w m d c d v c b g p cu d. g

u d b d f c w m d c d v c d d p cu d ug gu p c du , d c b

c 4.1.4 b v . p b d d m dd v c w d c g d v d d c m m u

u , c m u c u c gu C -m k d d v c . c m d c d v c b d - u p duc , p c d c

4.1.6. w v , c d m c v d d b c p c du

d p b d d b p p d muv qu . W c p d d m d c

v c cc p m d c d v c d c p wp b m d c d v c c b u d

c w . d b c b u w u u c mmp c d d m d c d v c w v , ug

m w -c c -c u d w b cu .

Donation PolicyT b p c d m d c d v c

d w g x : m d c d v c p p d d u d .

f c v v u d d u d u c c d b cc p d.

d d m d c d v c u d b c - f c v pb., p d m c .

d d m d c d v c u d b cc p d cc. b p p d, p d, m d d pp p u d.

d d m d c d v c , w u d, u d b d bd. d b pm d p , c

d w k g m b c ud d m .


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48 Ministry o ealth

d d m d c d v c u d b C -m k d d b c-.c mp d b u m u , p b b

gu g . cc p c g d g u d b c d.

d d m d c d v c . D d m d c d v c b c ud d m c m.

B cc p g u b d u d m d c d v cg.u d b b d m u c u c u

p v d p p , d xp c c m dd v c u d b d c d.

d, b k , u m d d, d du d m d c d v c . w c p p d c um b g v m d c d v c w c g upp d b

m u c u u d b cc p d d . D P b v b d c.w c m d c d v c d d d w c c

upp v b p c c p d b d .

Responsibilities o parties involved in Donation activities It is the responsibility o the MoH

mu c p c , gu d dmu cc p g d d m d c d v c d c

mu c p c p d .

It is the responsibility o the recipient: d p c d u b M . T c p p b p c

qu m cc p g d d m d c d vd c mmu c qu m f c v

d . u p b c u d w f p p d d m d

d v c u , c b u d

w d u qu m . It is the responsibility o the donor:

u d d m d c d v c u qum u b c p w w g c b gu d w b . T d u

p b u g d d m


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d v c u d u u c w v d. T d p b d v

d d m d c d v c , c ud g b m ucc d c um b w c cc m

g d cum .

Procedures and RoutinesT b d cum d p c du

p b w d d c p . T d d c p k c qu p w b p

p c c d , p b d qu mc p d p c k w w c p c du w. T p c du b g d d d cum

d d b m d v b d d c p w upp v c c g g f m m

d v c . p c du c u u b m dv w d d upd d d u c c , c

d pp c b .

x 4 d c b p c du d c v d d d cqu ucc u d m d c d v c pub c c c . m b d d c p d p u w p c du d b b

ucc u d .T d gu d d v p d c mp c w

c mm d mu d W d g (W ) gu d c qu pm d

4.2 Guidelines on Acceptance est o Medical Devices

4.2.1 Introduction and BackgroundT m cc p c u m d c d v

b d v d cc d g c c d u MDD c . w b d m d c d v cp cc p c b c b u d p

p m g m mu g z c p c du


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50 Ministry o ealth

cu qu m p c d. T C c gg U (C U) c mp b d x cu c b w upp . v c mp x d

b d m qu d p p m c p c . uc c c c g g m

p c du . w cc p c b p mmu b d p cu m d cum .

T cc p c u m d c d v c : d v d c mp d g d c d w u

b d c d v d u w k g d d p m xp cc d c w d u

P c d u d c cg g u ( c ud g c c )

d v d w u d cum c udu m u gu g

d v d w c g u d guc u c p d v c d

g c m g c m c .

4.2.2 Policy

c p v u w m d.d v c m b u d p cc p c g. cc p c g b p m d b c c b.

c ck d v , m k pp p m k m d c d v c w v g b

pp v d u . m d c d v c pp v d u bc.

v g d v c .M d c d v c d b v g d.

b u d. m d c d v c p b g.M d c D v c m m (MD ) m d

c c g .


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It is the responsibility o hospital management m k u w b d m d c d v c

pu c c v c w u ucc u cc p cc d u b C c g .

It is the responsibility o the head o clinical services u m d c d v c g

M d c D v c m m, d c d

v g, c c u / c c

It is the responsibility o Clinical Engineering Unit: c u cc p c p w g m d c d v c M d c D v c

m w u d .

It is the responsibility o the user u m d c d v c c v


W w m d c d v c d d c p v m c p d b g b d , .

C U. T u p p cc p c b w d v c c du d v p w

upp d w d g v b p m d w d v

c . dm p, d g d C U p v c u din box 4. W cc p c p v dc c d v c b u d w m dd v c w v g.


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52 Ministry o ealth

4.2.5 Registration o Medical Devices

cc p c m d c d v c b g v d m c m (MD ). gd c d k p g mp f c v m

c d v c m g m . v g g d m d c d v

m c m p u c p gw p b m m . g d c d k p g m d c d v c d d d :

g v m d c d v c u qu d ,.p v d d v , p d m c d b.

c d v c d ,p v d m b u u g c ,c.

Box 4. Roadmap designed to assist the CEUto pass a new medical device (acceptance tes-ting).C ck m d c d v c d cc c mp w pu c d cum ( p d v -

d).C ck C m k/ pp c b d d d -d d u .

x m w u m u cc p b

d gu g .x m w c c d cum d qu .x m w b g m d cc d c

w v d d d m k g d qu -.

P m c ( c c , g ).g d v c p M d c D v c

m m ( v g). d p m u c c (w

u ).C ck d/ p m g f, u d

c .P p p d p v v m c .


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k pp p c w g m u c u wd.d w , d

c m d c d v c v b u d p cc d.

m d c d v c v p d cc p c g p d b c c u b g d d b gu qu g umb , m d v

g. v g c b b d m g cM d c D v c ( MD) C U. T v g b x d m d c d v c . m d c d v c

m k d w v g cc p d c c uc b u d p .

mp m b u m d c d v c bd d c b d c 3.2.

T C c g g U c p u d vk c u g , m c d d k p

m d c d v c . T u d b c u b C U g v m p cu

p c . d g c c d m d c d v v , M d c D v c m m (M

b d g d, mp m d, p d d m d b g c M d c D v c ( MD). T C U

c mm d m MD p c w m b g d d w m b upd d.

w u C U c u w MD c C p 3.2 d .

4.3 Guidelines on Clinical Use o Medical Devices


T m j c d d cc d w m d c d v du um m k b d u g . P c du w

p m d c d v c g mp p . M d m d c c

v v u v m d c d v c m m m d v c , w c c p k d


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54 Ministry o ealth

c . T mu b d cum d d d p c du u , bu p c du f u g m

d qu c mp . T b p g mm m c . b u d mp v d b

m dv v c . d p mc d v c c d m mp . p c

d qu m c mu b d cum d. g m b qu m.

M ud d c mm xp c w p b m

w m d c d v c ccu b c u f mw p p u c g d v c . M u vc v c v d g. pu d md u u d xp c d k w w

m d c d v c u c g. T ck g bk p w f. M

c d v c p d u du u m ud g . T c u p b m c c g

u u c k p b m - xc g u p p u g m d c d v c m k c b duc d.

w v , m d c d v c w - c g - b k d w . T u d v c mu p p

uc u . v d v c d m d muv b .

T c d c b p c du w c d b d p v d u g d

c d v c d c w .

4.3.2 Policy f w p d d/ u m.

c d v c mu v g d u c k w dg dg d g m d c d v c , c

pp p w . m d c d v c b u d d d d b qub.


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f d d w . f w pc. mu b w c d

d p k w u g d g m d c d v, d c d c p , d v p

k w dg w m g k . m d c d v c , - u m m d c d v c md.

c u , mu b pp v d u b c c gp u p .

g b p v d d m d c f g d g . d c u pp c b m d c d v c .

m d c d v c b cc mp d b u m u. p b b gu g .u - u c g m d c d v c mu b pg.

v d m b g b u d. cc d d dv v w m d c d v c .

p d d v g d. f w p u d g c .p u c m d c d v c p , d c d

w c c g w m g c d v c b w c c


It is the responsibility o MoH to: P v d u c d d u c uc c pub c p c u pp c b m d cv c d pp p w .B d c cc u b u d d g m

c d v c w p .

It is the responsibility o the hospital management to :

P v d c u c v f

g u c g w u m d c d v c d pp p w .

P v d c u c d mp mpp p p c du c u /c c.

C pp p p c du mp m c u /c c d m f c v .


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56 Ministry o ealth

It is the responsibility o the head o clinic to : u m d c d v c b g u d p p w d f g u c g

u m d c d v c .M k u m d c d v c b g u d c d c w d d w d b qu d f,

p c d b m u c u .mp m pp p p c du c u /c c.

It is the responsibility o the user to:

U m d c d v c d d w d

w p c du u w uc u m u .B w d c c p w c d v c w c d c p b .

m d c c c / d g m d c d v c v p b m w p g m dd v c .

p cc d c d w m d c d v c d C c.


c u /c c w p d /u md v c v p c du d c c d

m d c d v c . T p c du u d b g d d cum d d b m d v b f dm d c d v c . p c du u d c u u b m

d, v w d d upd d d u cc c d pp c b .

T b pp d c p (m d c d v c c

d ) m d c d v c c u /c c. T mc d v c c d p g p b mc d , m k g u m u v b , g z g g c v u , m k g qu v c , c

g c c g , d c d g u z m d c d v c . b d cum d, d m

k w , w c f u z u w c m d


53/111


c d v c . f u m d c d v c v pf u m d c d v c v ppp duc d g u d v c

c w d d cc d c w p c c m u c u ( u d u m u ).

4.3.5 Introduction o new Medical Devices, updatedSystems and So tware and raining upon Delivery

Up d v w m d c d v c upp mc d v c p v d g f g

u m d c d v c . T upp g v cg p b c c g gm m d c d v c u u . uc g cp m d v c c u - b c d u m u c u p m . U m u mu b m d v

b b gu g b upp . T c d b g upp b d d p

p cu m p c . B w m d c d v c b ug v c , cc p c g d gb p m d b qu d c c g . m d c d v c c d u b upp mu

cc p c c c b c c g .

4.3.6 raining a ter Update

M d c d v c d m w w p v c m b ubj c d upd w u

c d u c c b c g d. uc upd , v f mu b d d b m d w c g d u c-

. M d c d v c g upd d w w u cc , w m b k cu u c g p v d d. uc g c

p v d d b c c g upp /m u c u p b d u /c c u m g k w v f.

4.3.7 User Manuals

T b u u m d c d v c


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58 Ministry o ealth

b g b d cc mp d w u m u . u d d u d d u m u p u . U m u b k p d d k w c

w c cc b b pp c b f.

4.3.8 Continuous raining

M d c d v c qu c u u g bd b d c c/c c g . T b p

du c u u m g d

m d c f. C c g m d b u p c c p m d c d v c qu xu g d u d f c vW u p b m d m d c d v

x u g b m d v b vC c g w k c w c u /c

d /u m d c d v c d c - d d mv b u g v f. T g

m d v b gu , w d d up qu u . P m d g u d b d cum d.

4.3.9 Procedures or Use

m d c d v c p d g c pp c du . uc u /c c mu v d v p d pc du d c w k p . W m d cd v c u d v mp p c duw k w w d. M c mp x p c du mu b d cum d d c k d c

m g k w k .

4.3.10 Function est

T b u u /c c m k u m d c d v c p d b g u d p

g p ) mu b c ck d p c u . u c b c d u cc d c w d c

u m u cc d c w uc c c g . u c c


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p c . m d c d v c d p u c b u d p .

4.3.11 Critical Devices

M d c d v c c c u c mp c d mqu p c c u . T d m w cc m d c d v c b p c d b d c

u b d cum d d p c w xg d d, w c f d w k w dg

m d. u c m b g d uccg.

4.3.12 Accessories

M d c d v c d cc v u cp cc v b . cc v

c mm d d b m u c u b u d. U cc m b u d d p m

m d c d v c c b gu d b qu d cg . P uc u k m u d b p

m d b c c g .

4.3.13 Medical Device Mal unction

M d c d v c v d c d p b m u p cv m u c mu b p d c c g

m d c d v c b k u v c d b gg d w w g c b u d. pp c b u

m d c d v c mu b m d d v c u . T m dc d v c m b u d g g p c du u p b m v d. m d c d v c w g v c

p , mu b d p c . uc cb d d d c mu b g z d uc w u c g m d c d v c c g m x d up w - u

g. m d c d v c b u d w cc d u p c d cc d , ccu d mu b p d cc

c w u p g cc d d c d Gu d c 3.1)


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60 Ministry o ealth

4.3.14 Accidents and Incidents

M d c d v c w c v b u d w cc d p ju v ccu d, c u d v ccu d, u

b ubj c d v g . uc m d c d v c mu k u v c d b gg d w w g c b u d. pp c b f mu b m d

d v c u . T m d c d v c m b u d u c v g d d u c

b c d u b c c g . T p c du

p g cc d d c d b m d k w f. T p c du c mp w c mm d dv v p g ( ) m. P

c p 3.1 gu d .

4.3.15 Maintenance

T U /C c v m mp m d m d p m c m d c d v c c u

b , p b up v d b c c g . m m u p c u m p , m

bu , c c g mm d u g b pp p u c . m d

d v c b g d m c p g m d d d p c du p v v m c . T m

c p g mm c b up v d b c c g .

4.3.16 Use o In-house produced Medical Devices

T b d cum d u - u p duc m d c d v c uc b u d ( c 4.1.6). T

u pp d v c m d d w

cc d c w g m u c u c mm m d c d v c . - u m d c d v c mupp v d d d b c c g p u

c c g b p b d qu p m d c d v c b g pp d. - u m d c

v c cc p d b v g d vu m u w b gu g .


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4.3.17 Disposal o Medical Devices

M d c d v c d m d u u b b k u v c . d m d c d v c

b d p d. D p m d c d v c b cc d c w c mm d d u d w

c c c g . D p d m d c d v c b u d g g p c du . T d p mu b

v m d b c d u cc d c w p c du w m g m , u d

c p 4.5 d cum .

4.4 Guidelines on Maintenance o Medical Devices


c c m d v c mu b xp d mc p c du d u c d d d

w v b d c c d. T m c c m c mp c u pu xp c d. T

m c p c du g mp c d c c .

4.4.2 Policy

M c m d c d v c b p m d .p d c - f c v w uc ccb , p m c d m d du g

m p duc . m c m d c d v c mu b p d, pb.

d, p m d d d cum d p d

c c b w c c u d v , - u w ubc c d, m c c.b p m d u d p b d up v

c c g .v u d d c g d g p v v md.

c p c du , m d m c , w u ubc c , d d cum d m c


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62 Ministry o ealth

p c p c c m d c d v c b m d du p cu m p c .

d u b g d g u c d .p v v m c b d qu m d dm d m:

- T w.- gu .- M u c u c mm d .- T u .

M c b p d d p m d uc .

c c w k u c d p b . m c mu b d cum d d c d d g.MD .

4.4.4 Preventive Maintenance asks

P v v m c (p d v c ) v v m w p c d p c m c c p b b k d w , d b d v u p m b-

c - f c v , .g.c mm d m m u c u ,

p m ,c g c m ,d cum d c c xp c ,c c d ,

k cc b u c

P v v m c m b x cu d , pb C U ug c c w x upp

m d c d v c v c . T d c b b k d c - f c v .

d b bu c c c d v c c c

Du g p d p v v m c c c v c b p m d, d pp p . T c

c d d d p d c c v m c . m d c d v c c mu b v u d

u d b c ud d m p v v mT v u b b d m c qu m


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d k . m c m d c d v c m k d w m x p v v m c . Tc c u mu b m d w p v v m

b p m d d b u u m

4.4.5 Corrective Maintenance asks

C c v m c (u p d b kd w ) d pc b x cu d , p b C U ugc c x upp . T c c g

v u w p b c d g u d v c d c p . D c b m d c - p w u , c ud g w

v c m x upp d d. D cum c v p m d c ud b v m d

p c m p p d w up p v u c ud g c m c p m b p m d.

4.4.6 Sa ety and Function Control

m c p c du , - u w ubc d, d u c c mu b p m d

d cum d b d v c k u . pu d g d du c c p b m , d

d du g m c , b p d cc d g dv v p g m. c 3

4.4.7 Registration

c v xp c d du g m c , u c c mu b d cum d, c ud g b v

, p c d p p d c . T m

d cum d b u c v u d p v v m c , c m c c qu c , p cm m d c d v c , w p c , d pp upp d m d c . D cum d u

p v v m c p g mm b bc d d v w d c c m d , .g. MD ,

pu p c b . T d cum c d


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64 Ministry o ealth

b v u d d dju d c b cu u mp v m d c - f c v p vv

m c p .

4.4.8 Competence and Responsibility

M p b m c c . T M d g d

b p m c p d c . T d c c d g p m c p C

B C b C U d upp . D g p b mu c ud d g u c c k. M c p m d b p c

c g g p , B C p m uppu d c c g g c . m c d v

upp k B C b m d. Quc c g v d cum d u c d c

duc d g c g u m c

4.4.9 Priority o Maintenance o Medical Devices

P v v m c b p m d d :

upp g qu pm w mp k.up u c , d b

b qu pm w p c qu m qb..

X- d v qu pm m u d cc.w mp k p up u c , d

b . qu pm w u p d p w b u cc pd.

b c d m g qu pm .


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4.5 Guidelines on Disposal o Medical Devices


T m w m d c d v c c b ubj c d p . m g v p b m c

b p d, p m b m xp v c u cqu g w m d c d v c . m v

m p b m c b c c d, g k g cu d d . uc m d c d v

mu b p v d m b g u d. m m d c d v c bc m u d d d m g b d d g gp c du . uc m d c d v c d c d b d p d b d mb g. Bu g g b k

m pp u d d m dd v c w. Qu w m d c d v c

d p c d m d c d v c d w w d v d v d f w k p d m d c d w . m d c d v c w p c d du c w u b k u v c . T d p

m d c d v c m c u c c c c d p cu w c c g m d up d g

w f. T u mu b p d b . T c c g mu v w

c p u u w c qu c m d c d v c k u v c .

p c k g c d p d m d c d v p c um d v m mu b

p . c m d c d v c c m p m c u d g d c c g p m p d

u d v gu .

M d c d v c c p c c g c p , c md u d , d c v ub c , c c d c

p , b d x c p c m m m z d u d m qu x c .

u m m d c d v c m v


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66 Ministry o ealth

d c um b , cc d g -u m b g u d g w m d c d v c . T p

c b d p m d c d v c d u dd m d c d v c .

M d c d v c g p c p c m , gm , b d mp , c u d - c u cw . T m b c d d d p mc d v c d w b c v d c . T p

m u uc d v c w g v c mm d

w k c uc m d c mm d w b w d. dd c w mm p p w b w d.

T c g v gu d c d p u p b c d b b d

v m m d c d v c u u . Mc d v c c b d m w uw d d w u d m w k. vm mp c m g mu b c d d

p c w d g w m d c d v c g md w b g , ug f c v m c

m k m d c d v c g d c up p p w . d b f c v wm g m c qu w p

w k c c c d w u d v m . T mp m uc u c

c d d d g v m p b .T c d c b p c du d b

d p v d u d pd p m d c d v c . d c b p qu

d c w m d c d v c b c d

b d p d.4.5.2 Policy

m d c d v c p v d g d d u c .u d d d w d c v

g mu b c c u .


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M d c d v c u p c d v d g, mb.d g, v u p c u d v ,

p c d, xp d d u , b w bv c w b d c v u mup v d m b g u d.D p m d c d v c mu c mp w w , gc.

, d c mm d m u c u w pp c b u p w m g m p

qu pp c um b , cc dg -u m w c p m d c d v c .

C c d d p d m d c d v c mu b d uc d d. d w d mu b m x d up w m d cd v c c c u .

c p v w m g m p d.p d m d c d v c d u p c m

w m g m p d gu f w p d p m d c d v.

p , mu b w p w mg m p .


It is the responsibility o the MoH: p v d c u c d d c c k c d p d m d c d v c , d p

d v m p p w . d w c d d w , c g wd w d f w b d d.

It is the responsibility o the hospital manager : m d c d v c w p

u d d p d m d c d v c c b u

p v d u c mp m g p w

m g m p c ud m d c d v c , c umb , g -u m d cc w c pm d c d v c .

p v d c u c d mm pp p p c du d p p d p

d d mb m d c d v c c c g


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68 Ministry o ealth

g u v d p m w c cg c mp c .

m d c d m d d v c b d c

m d m c c g d qu cc g g u k c d c d d m dd v c u v c .

It is the responsibility o the head o clinic/unit: mp m u cc d c w p

w m g m p d p c um b

g -u m d cc w c p mc d v c . m k u e m d c d v c / c c u d gu m c c d u

c d c w m u c u c mm d d/ b ugg c c g .

It is the responsibility o the user: c c c c g m d c d v c

p c d v d g, m d g, v u p c u d v , xp d d u

b d c v u . w p w m g m p c

, c um b d g -u m pm d c d v c .

It is the responsibility o the clinical engineer: dv c p D c b u m d c d v c

ubj c d d p . k u v c , d d g d pp c

m d c d v c d c d d b d p d. c d d p d m d c d v c , d uc

u d p c d p c . upd M d c D v c m m, c g b k , cu u d p d m d

d v c .


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4.5.4 Procedures

T b d cum d u c c gg u c c d d p m d c d v c .

c c/u w p d p c um bc d g -u m p m d c

v u d p p d p . b g d d d cum d d b m d v

b f d p m d c d v c p p c du c u u b m d, v w d

upd d d u c c , c c d p c b . qu d p c du c c d d m d c d v c w g:

4.5.5 Disposal o Consumables, Accessories andSingle-use Items

c c c/u w p g d c um b , cc d g -u m

u d c c d p . T u mb m d k w v f c c/d pm . C um b , cc d g -u m d p d d d c w c fp . D p mu b m d v m w d b cc d c w p w m gm p d p c v m

m v c c d d p d m b m d guw c c d g /c mp .

4.5.6 Monitoring o medical devices

T c c g g u c u u m

u m d c d v c w p c d p . d b ubj c d v d g, m d g, u pu , d v p c d du c g m

p c du , xp d d u , b w b v c w b d c v u b k

c c u d b d g d d pp c . d v c b c d d d d p c d


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70 Ministry o ealth

. T c c g g u g wu M d c D v c m m (MD ).

4.5.7 Investigation

c c g c u v g c d v c ubj c d d p . T b cu c b w d c c w c p

u m d c d v c d . uc v c d m d c d v c p b

w k d d mb m d qu d, -c c p b p p , v g c c u d d d ugg w m d c d v c

b d. m d c d v c w m p u d b c d d b d p d. T u

v g b d cum d d c b p mp p . upp v m m g b k ( M d c D v c m m) c b c d. T d cum c ud c mm d

m c c g d p c k w m d c d v c c d d u u .

4.5.8 Disposal Certi cate or a Medical Device

W m d c d v c c d d b u b u d, cc d c w d c p b v , m b u d

g g p c du . T c c g mu k pc u p v m d c d v c m b g u d

m p m g w d v c u . T m v g b p d p

g w w v p b k d m d c d v c w c mm d c c

c d k mu b u d. pm g g d p c c , w c w cm d c , d d v c c g

qu k m d c d v c u v c .


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4.5.9 ake the medical device out o service

T c c g g u (C U) v u u g d p d m d c d v c c b u d

g g c c p c du . T d p d m d c d v c b d uc d w c b u d. T d ucmu b p m bu d c ud p mc d v c . p c c c w g m

ug ju m v p w c d b . P c b u d p p c b

d qu g d d c c g c b p p u c g p p .

4.5.10. Medical Device In ormation System

W m d c d v c d p d g x c v d v c v m M d c D

m m (MD ). c d b u m dd v c c b k p d u u c , bu m dd v c g x v m. T

b upd d d v g mu b m v d u d d uc d. umb d m k

m m u . m d c d v c d b v g b d pp v d u .

4.5.11 Disassembly o disposed medical devices

T c c g g u (C U) v u d mb m d c d v c . p c w ww d f m d p mu b c d d. T

g m qu p c p c u d d cum d u

a. Fluidsu d p c u d g d c g ppuc dg d z (c c cu ) d -

d . dg d z c g d c b v u d m v d u d c d . dg

z d d c g mm mu v m x c d d d u b c p


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72 Ministry o ealth

g d p . mm p z d u m , x c um d c p k

xp . c p c b u d X- g p c d b p (PCB). uc b m

d c c d p c . p c p c ub k w d g w PCB d d b m v d

d d p d pp p c d c .

b. Mercury containing componentsM cu u d g d c g mp , m d c d v c

d m , c mmu c , d m b p b u d b , m , p, d w c . u c c d

qu pm d c d g c c . pm b , m m cu c g m k

b u d c cu b d. Tu , m v g c cu b dw u d u m v m m cu c g cp uc w c . M cu c g c mp

d w d d u d m v m d m pp p b d c .

c. BatteriesB d b p ck ccu m m d c d v c

c b d d p d c cu b d . Bu d b m v d c uc w c

c g b b . m v d b u d b pp p b d c v g du g d

k b c p .

d. Circuit BoardsC cu b d mu b m v d w c cu b d

g p c . c m v d, mu b d u b

b d c b b b p cc v .

e. Cathode Ray ubesC d ub (C ) m u d c mpum v . d g C c pd g mp . c qu c , m w


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w d b u d c k. C v uc c g u d b m v d u d

c u p u m. C b p cc v .

. Liquid Crystal Displaysqu d c mb dd d b w g

c c c m . CD u d m (CD v ) d b ck- g d w g d c

mp . T w d b m v d, d b ck g w

d b p d m CD. m v d g dc g b ck- g d CD u d b d p p p b d c .

g. Components containing Radioactive Substancesd c v ub c p c u d m m d

d v c d um . T p c p c uk c d d c gu

b w d w w k g w d c v ub c , p w 1825 d P c c .

h. Capacitors containing Polychlorinated Biphenylsc , p c d b p (PCB ) w

v u d c c qu pm uc c p cm . w v , u p pp c

w d b d 1972 d v b u d m u c u w qu pm c 1986. Tu , u

pp c m 20 d, k cc p c c g PCB v m . PCB c m

v m d um . c p c , d d c g PCB , w d b m v d d d p d

pp p c d c .

i. Electrolyte CapacitorsC p c u d p c m g c p c

upp u m . Cu d ub c c c , d m d c c p u k c z d u ub c .

c p c w m u d d c c cu b


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74 Ministry o ealth

d u w u d b m v d c cu b d m v d.

4.5.12 Storage and Collection

pp p g mu b p c d mb d pT g f pp p p g c c c

, b f d p d b d xp d g . c w d p d m

d mb d p b c m k d.

pp p c x g bp c c g PCB d z d u w uc d c v w . b u d b d d d

w g d p k c d w P ( .g. m d c mp ) c d/

u d mu b pp p d gg g d d c cu d uc d

c c p m m. T c mu b d w mp m b u c d d d

m. x c w mu b d d ub c b c c m k g. T z d u c c w

w p : c u d - c u (c m c ). T c u z d u c c w w b gu d u

p c c w z d u w m g m d u d c p d cum , c b p d w .

M d c d v c w g m v b d w u mu b k p p m c c

T u d b d ck b g m. m d c c , c d , w g m , c d

m m . mu b c d v c k

v c . p g d c g u b b d v c . T d v c mu b d uc

4.5.13 Planning or Replacement o Medical Devices

v m c d d c , m v g p c b c p d


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m p g c v . T qu m p c c , wcqu g w m d c d v c , qu m

p p d p m d c d v c . T m u c ud/ d bu f v k -b ck c p c c c d m d c d v c , cc w u p D c v c c d c

W (W ).


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76 Ministry o ealth

5. Health echnology Assessment

5.1 Vision

T M v c g ( ) c w W d g z c p qu d v pm m , w c c d x g v d c mp

c g d u d c p p d u m : g z , p c , p c du , d v

d d ug .

T w u m c m d c m. p c g m c m , d c .T bj c v c g m p vb.

d c m k mu b c c v b p c , c d c c d c

c c w g d pp p u T u z m duc vc.u , m u u d u c g d m x m mp v g , d c

c v m . p b d c p c b d p w

p c v d c b d d c m k g.u z d p m g ucd.

p c u b p duc g m c c g

m w p w gu d p c d c c pw d b p b d c u c m . 5.2 Institutionalization o H A

u z b d v p d w pd g c pp c : p -d w d b m-up .


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Te top-down approach c ud b m - C p b c u d p duc

c qu d v d c w c c g p cu qu dd d c .

c x u z dd w uc u C

, d cc d u ( Cw d p m d g w , v d c BM d c ( BM) d Gu d B C c P cT CQ w c c u g g c M

du g d c -m k g p c w g c g m .

Te bottom-up approach m p d c m , c mp d v u u c m ,

d c c g u d d cu c p c c . T k d xp c d b c duc d bm qu m m , m c ud

d c mp qu d c , cc d , p d p c . T pp c m v

c mp c duc u c u c g , m m z v u , m u u

u , p c m c c g d duc b w d m f c v .

B m-up pp c d b b d p - m v w d b p c c d c u

qu c d v pm pp c . u u c v u pp p d u c d m

b u z d . C v , c ud cm d c d b d qu d v pmm u cc d g . M c p c c c

mu w c b d xc g mw c u d d. b p g mm k p c v d w k

Cooperation at the national level v v :C d c v d p ..

b m c b d w g m db.


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78 Ministry o ealth

c d d p - g.D c z c w uc.C p m m xc g d.

d p .Mu d c p ..

b m m k p c ..

Cooperation at the international networking level v v :P c p j p j c ;.C - u u d b g v g p ;b.

xc g m , p j c p , d mc. .

T c p c bu d g d m c g BM p qu u z

. g d duc g xpg z d f qu c . g d duc

g c ud c u , pc , du , m d c d v c m u c u , c d

u , c mbu m d u d g gd p c -m k g u . mp m

u b b d mp w m d c -m kb m g d duc .

u u d v pm c ud g u d b c m f c v , d v p

c mm u p m g d m d g d d v pm p d m c m d

g g b v ud d g d .


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Annexes

Annex 1Te Legislative Framework or Public Procurementin Albania

T c v pub c p b b d umb 9106, d d 17 Ju 2003,On the hospital care in the

Republic o Albania. T c gu p c pc d m g m d p g c v p .

T c gu w g u :p p g c d g v .p m g m .

T p p v p .

c p c g ( u z ) p b M

c p uc u m d c c mm w c c b d g v c c dv c b d

d c g p u . c mpd c p , c v c w

v c d m v c d u c w p u . m g u c c mm

c p p b d d c pm d c , d g c d p u c qu pm b pu c d. cc d g w, pub c p

c d b :T M .

u c u .

c u . D m c d g d .

p x c c v w g c c u w d p d b p cu m d, c mp d p u d

Pub c P cu m g .


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80 Ministry o ealth

T pub c p cu m b b d w g cT w umb 9643, d d 20 v mb 2006 On PublicProcurement, d c b 1 J u 2007 ug

pp v b P p mb pub c .

T D c umb 1, d d 10 J u 2007 On ap- proved o rules on public procurement, d c 20 J u 2007 ug pp v b C u c M -

.

T Pub c P cu m w (PP ) u u pp p cu m g d , w k d v c b c

c g u . T w b d U gu p cu m p c du . T bj c v

w : p m c c d c c pub c p cu m

p c du c d b c c g u . u b u pub c u d d duc p c

du c . c u g c m c p p c p pub

p cu m p c du . p m c mp m g c m c p . gu qu d -d c m m

c m c p p c p g pub c pm p c du .

gu g , pub c u d p cpub c p cu m p c du .

T w g w d g p c p uc : d c m d qu m c u

p d ,

p c p cu m p c du , d

p p qu m d b g mpc u d p d .

T PP pp w d g p c du . T pp c bxc p w c gu d w w

m c g d g d c p cu m , c cc d c c qu g p c cu m u


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v c c c w d d b xc u v w c j pu u pub d g .

w p c du w c z d pu c g. ccu w m c c g u d

m k d g d , w k v c . c u m d c d v c z d pu c g

w : g m k p cu g uc m b .

uc C Pu c g B d b d pu u

p cu m gu c u vw d g p c du .

C c g u m k c pu c g c u p c c w d g p c du wg p c du b w c z d pu c

w u d b m ub c m c , c g d g upp m g u g d w c

f d m k u d m c d . cu w d g p c du g d , C

c g B d ubj c p v PP .

T pub c p cu m g z b d p b c c g u ( p ). c c

u p b p cu m w pub c u d p ubj c p v PP , u

c d p cu m gu .

p cu m p c bu m c mm pcu m u uc :

-d c m .

cc v m .

m c mmu c .c c p c c .m w d g p c du .

C d . v d c c up d c c .M d c cu g m d v u pub c c


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82 Ministry o ealth

T d .

cc d g PP , c c p c c c d c c g u qu m b c

d d p g ccd d , cc p d c c pp v ,

m c c p c c , d d , c c c m b d b

d d z b d , w d x , d d , c c pp v c

p c c g d g , c cu d x c w k d u p duc .qu m m p m c , v w qu m k g c

d d m p um g c m w ucp m c u c qu m .B m d d f p duc , v c w k c ud d m c c .

d d, d c p w k , g d v c c c p c c b c v d, c ud g p

d w g d m d . c u c d c p w g d , c c p c c u d c d u

d c b c p w k , d d c d c cum c w c mp p p

b d. T d c p d c c pw k, bu qu m d m d w k

c c , c m c, c d u c p c . gu c mp b d c

bj c qu m g d u cc mp d b dd b p v d d w p c qm u c p m c , u p g m d

g b d p p . p c c upp pp g d v c v m b d d c p w k .

T b qu m c cc p c c p cu d m k m , pd g p , p c c g , p duc v c p vu u c p c g b


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d c b g p cu m qu m d p v d d w d uc or equivalent c ud d p c c .

T pp c b d pu p PP :g v u d w c 600 000 000 pub-c b u c c d 100 000 000 pub c c -

c v c d g d .w v u d w c 3 000 000 pub cb u c c d

2 000 000 pub c c c v c d g d .

w d g pub c c c , c c g u pp p c du PP .

T p p c du b u d w d pub c pcu m c c b :

p p c du .c d p c du .

g d p c du , w w u p pub c c c c .qu p p .

D g c .

c c , p p c du c w b u d. cc b v w v u d , c c g u

u p p c du , c d p c du , d g c. c c v u w w v u

d , c c g u m u g d p c dw w u p pub c d qu p p

m v u pu c g d , v c w k , b w d, c c g u m u mp

p c du .

C c g u w g w d pub c cp , c d g d p c du m k k

b m c c c . C c c c v u b v g v u d

b pub d Pub c P cu m Bu , d w p p u p d bu . C c


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84 Ministry o ealth

c c c v u w g v u d , bu b v w v u d , b pub

Pub c P cu m Bu .

m - m c p qu p c p d c p d v d p d g d f k d p cdu d d . g m up 52 d

d w c c c pub d. Tc p cu m v c m c m d c v c , w v c p cu d g w

m d c d v c dm v u d gu dv u k d p c du .

Contract Award Criteria

C c g u m award public contracts - w c m qu c c d p

f w w p c . C c g u mv u c , x mp : qu , p c , c c

c d u c c c c , v mc c , u g c , c f c v , -c d c c c , d v d d d v p

p d c mp , p v d d c :C k d ubj c -m pub c c

b w d d.bj c v , p p d -d c m .

C u c c c dm .C u qu d qu m m g

v u d , d xp d m mu g ail/pass criteria.

, g v c c , m d pp b m w g d , w k v cc g u , b m j c

d , qu w g d d :T c m c c uc m d, m u c-

u g p c v c p v d d.


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T c c u c d/ xc pv u b c d v b d

w k, upp g d v cT g w k, upp v c p pb d .C mp c w p v g mp mp c d w k g c d c pw w k, v c upp b p m d.

C c g u v c u

m d m j c , d d gu v p c .

c w d c c b g v p mp d w ubm d d d d

ucc u d . W d m cw d, c c g u d c

c P cu m g c pub c Pub c P cum Bu . T c c w :

T m c d d .T p c f .T m d qu d d d f d p cT m ucc u d d f d p c

T c c g u d d g c c w 30 d pub c w d Pub c P cu m Bu . T p d b c

d b xc d p d f c v d , c c c d d cum

W c c g d b d d c c b m dm

v w, c c c d d u d v d.

T m c c w d d pu u PP d f m p c p b d

d cum d ucc u d . W u p jud c p v PP d g v p v

pp c b c c g u , c c w du PP b ubj c b c v w.


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86 Ministry o ealth

Administrative review procedures

p v g v g d b g puc c d w b k b g m d b d c

k b c c g u w c g PP , c g uc d c . bj c b d

c w c c d c c g u w g 5 d m d c mp b c m w uv b c m w g d b c PP .

Up c v g c mp w bj c , cc g u u p d g g c c w

p c du u bj c u x m d d mud d, x d m - m c c w d p c d p d u p .

T c c g u mu x m bj c d k ju d d c w 5 d c p bj

d mu m c mp k d c d ju c x w k g d

c c g u x m bj c5 d , j c bj c , c mp m w

pp w Pub c P cu m g c (PP ) w x v d . T c mp PP u d b c mp d u -g p c v mp , c g m d dd

c mp , c c c p c du , g g u d d d c p v . T b v m

x m c mp . T PP x c mp , w g w, C d dm

P c du d pub c p cu m u . u c mp g g m k m d c mp v d.

Up c v g c mp w pp , cu u p d g g c c w d p c dUp c v g c mp w pp , PuP cu m g c p d w v d . W c c g u qu m v wc mp , g c p d w g, cc dw pub c p cu m u , bu 20 d


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Up c v g c mp w pp , PP u c c g u u p d

g g c c w d p c du . P c c u pub c p cu m c c , PP p w :

M k d c w g d g u pp w c pp ubj c m c mp u w p c d c c

c g u c w PP . T c p w m v c c p p c

c , w c d c mp w PP .uc c c g u c c bd p c d w c c w d p c du ,

uc c c .d m c c w d p c du .

w g c c u pub c p cu m cPP p w :M k d c w g d g u pp w c pp ubj c m c mp

u d c d c b d w c c mp w uf d d m g , u b c PP m c m d m g b C u .

k m u g p b p : pu w v u m 50.000 100.000 d

p p d c p m u d cc g u .

w g c d c m d m d m m , p v d d c 63

PP , w PP d d x m c mp , c m-p v g d u c dm

c c D c C u . T x m c mp b C u m k g u d u p p cu m p c du , c c u

pub c c c g d , v c d w k b cg u , x cu b g , cc p cu m c c b w p .


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88 Ministry o ealth

w u Pub c P cu m dv c . B c mp , w v , Pub c P c

m dv c m v g p c du , b v u p c b g m

PP . T PP dv c d c p v g d p d PP wd m c p c mp , mm d

d c v g / w k . Pub c P cu m dv c

g u d g m pub c p cu m p c du

c PP g v, d mp m , / gc mm d p p c g , m dm d/

mp v m w .P p m dm mp v m dm

gu c c g u d p d w uc gu v w PP .

u c v v c c g u p

v , pub c u c p w Pub c Pm dv c c u g u d Pub c P cum dv c qu m c mp u

dm v p c du d k d c p m

T w c w U gu c d p c du uc c , v d , d d d cum , g m m p c p

d , qu c d d qu c d ,d cu , p g d x m d , d c

c w d c d c w d d gc c . T c m c mp c PP d

duc w u Pub c P cu

dv c c u c u x p c du c c u w pu p v pc c g u w d c mp

b v m d u .


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Annex 2Checklist o Questions to be addressed prior to Procure-ment o Medical Devices

Question ApplicableYes/No

Extracost?

Specify

RegulatoryWhich test house has certified the CE-mark (not for class I product).If the device is not CE-marked with whichsafety standards does the medical devicecomply? (Standard, Test House,Certificate)

What is the intended use according to themanufacturer?

InstallationIs installation included?Within what time from ordering date willinstallation be completed?Does the medical device require specialfacilities or constructions in the premises,such as ventilation, water, sewerage andelectrical wiring

TrainingWhat kind of training is offered for users?What kind of education level is neededfrom the operator?What kind of service training is offered for a clinical engineer?

ConsumablesAre there consumables and accessoriesavailable in stock?What other brands of consumables andaccessories are safe to use according to themanufacturer?

MaintenanceWhat kind of maintenance is required by aclinical engineer?What kind of maintenance and/or cleaningis required from the operator?Are there any critical spare parts or itemsthat need to be replaced regularly?Is there a supply of all spare partsavailable?Does the device require calibration, and if so how is that carried out? Calibration kits?

For how many years from the date of lastmanufacture is the supply of spare parts


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90 Ministry o ealth

guaranteed?What kind of training does themanufacturer provide for the supplier?

SoftwareDoes the medical device include software,and if so in which user language?Is software for fault finding provided?Are there any service or maintenancerestrictions, or functions that require passwords which are not accessible.Are upgrades for software driven devicesavailable and free of charge?Is there a remote diagnostic supportservice? If so, how is this operated andsupported? Is the support via a modemlink?

Offered servicesIs service contract offered, and at whichlevels?How fa

Documents

Albanian Policy