Briefing Session on theBriefing Session on the Draft ...€¦ · Current Honggg g y Kong’s Regulatory Environment NO overarching legislation that regulates the manufacture,,p, import,

Briefing Session on theBriefing Session on the Draft Guidance Notes for Listing of

Distributors of Medical Devices

Nov 2014MDCO

Department of Health

www.mdco.gov.hkwww.mdco.gov.hk

Outline Outline

1 Introduction to MDCO & MDACS1. Introduction to MDCO & MDACS2. Key points of Draft Guidance Notes Definition Requirements Requirements Others

3. Application Form

4. Q&A

www.mdco.gov.hkwww.mdco.gov.hk 2

Current Hong Kong’s Regulatory Current Hong Kong’s Regulatory g g g yg g g yEnvironmentEnvironment

NO overarching legislation that regulates the manufacture, import, sale and use of medical , p ,devices in HK

A voluntary Medical Device Administrative A voluntary Medical Device Administrative Control System (MDACS) was established in November 2004 to regulate medical devicesNovember 2004 to regulate medical devices

MDACS is managed by Medical Device Control Offi (MDCO) f h D f H l hOffice (MDCO) of the Department of Health


Medical Device Control Office Medical Device Control Office (MDCO)(MDCO)

Established in July 2004

Develop and implement the Medical Device Administrative Control SystemDevice Administrative Control System (MDACS)

Plan and prepare for the future statutory control on Medical Devicescontrol on Medical Devices


Objectives of MDACSObjectives of MDACSjj

The Objectives of implementing MDACS are: To help raise public awareness of the

importance of the use of safe medical devicesimportance of the use of safe medical devices

To enable traders to familiarise themselves with the future mandatory requirements

To collect feedback from the trade and industry To collect feedback from the trade and industry


Scope of MDACSScope of MDACSScope of MDACSScope of MDACSMDACS

Pre-market Control Post-market controlPre market Control

Product Listing• Class II – IV MDs

Post market control

Recalls and Safety Alerts

• Class D IVDMDs

Trader Listing

Adverse Incident Report

Tracking of specified MDs• Local Manufacturer• Local Responsible Person (LRP)*• Importer

Recognition of Conformity A t B di (CAB )

Note: * LRP = Authorized Representative (AR)


Assessment Bodies (CABs) p ( )

Regulatory Framework of MDRegulatory Framework of MDg yg y MDACS is modelled on the recommendations of the Global

Harmonization Task Force (GHTF)* and World Health O i ti (WHO)Organization (WHO)

Risk-based approach - Level of control proportional to degree of risk classified according to GHTF’s recommendations

Class of MDs Risk Level Class of IVDMDs Risk LevelClass of MDs Risk Level

I Low

II Medium – Low

A Low

B Medium – Lowed u o

III Medium – High

IV High

B Medium Low

C Medium – High

D Highg D High

Note: * In 2011, GHTF is disbanded, and a new regulator-led group known as International Medical Device Regulators Forum (IMDRF) is formed


formed.

List of Medical DeviceList of Medical DeviceList of Medical DeviceList of Medical Device


List of Medical DeviceList of Medical DeviceList of Medical DeviceList of Medical Device


PrePre––market Controlmarket Control –– Traders ListingTraders ListingPrePre––market Control market Control –– Traders ListingTraders ListingListing Listing Requirements Validity

Local Manufacturer Business Registration Certificate 5 YearsLocal Manufacturer Business Registration Certificate ISO 13485 Certificate

5 Years

Local Responsible Business Registration Certificate N ALocal Responsible Person (LRP)

Business Registration Certificate Manufacturer’s Designation Letter Documented Procedures

N.A.

Importer Business Registration Certificate Quality Management System /

Documented Procedures

2 Years

Distributor ??? 3 Years

Remarks: No application fee is required for trader listing at present


Lists of TradersLists of TradersLists of TradersLists of Traders


Definition of DistributorDefinition of Distributor Distributor# means any natural or legal

person (other than a manufacturer, an importer or a retailer) in the supply chain who, on his own behalf, furthers the availability of a medical device falling within y gthe scope of the MDACS to the end user.

# essentially modelled on GHTF's version with modifications made to suit local situationmodifications made to suit local situation.


Definition of DistributorDefinition of DistributorNote: The following are exempted from the

scope of listing as distributor:scope of listing as distributor: (i) A person who purchases or receives medical

d i ( ) l i l f ’ ldevice(s) exclusively for one’s own personal use;

(ii) Retailer who supplies a medical device or (ii) Retailer who supplies a medical device, or provides a service utilising a medical device, solely and directly to the end user; y ;

(iii) Health care facility or provider that provides di ti th ti i t ti t( ) /diagnostic or therapeutic services to patient(s) / individual(s);


Definition of DistributorDefinition of DistributorNote: (cont’d) (iv) A business party which purchases or receives (iv) A business party which purchases or receives

medical device(s) solely for use by its employees during work activities (e.g. first aid kits and disposable gloves) or for incidental emergency use as long as one is not in the business of offering healthcare service(s) to employees or other individuals; andemployees or other individuals; and

(v) A person in the supply chain involved in activities such as storage and transport of medical devices onsuch as storage and transport of medical devices on behalf of the manufacturer, importer, distributor or Local Responsible Person (LRP).p ( )In case of dispute, the final decision rests with MDCO.

www.mdco.gov.hkwww.mdco.gov.hk

MDCO.

14

Listing RequirementsListing Requirementsg qg qSubmission of application- by hand or by recorded delivery mail to MDCO- contain completed application form in original copyplusEITHER(ii) a submission folder containing copies of all required documents (by hardcopies)OR(ii) softcopies of all the required documents recorded in 2

t CD ROM /DVD ROM (b ft i )separate CD-ROMs/DVD-ROMs (by softcopies)


Listing RequirementsListing Requirementsg qg q

Establish & maintain documented procedures for:

(Mandatory) Distribution procedures and records Handling, Storage and Delivery of MDs

Sample procedure in Appendix 2 for illustration purpose


Listing RequirementsListing Requirementsg qg q

Establish & maintain documented procedures for

*Complaints handlingSameSame

*Product alerts, modifications and recalls *Managing reportable adverse incidents in HK

Same Same as as

LRPLRP *Tracking of specific medical devices *Maintenance and services arrangementsg

(* where applicable, depending on agreement with the ( pp , p g gmanufacturer and LRP, see Guidance Notes for details)


Mandatory Mandatory documented procedures documented procedures yy ppDistribution procedures and records- The listed distributor shall maintain thedistribution records for the medical devices itdistributes. Such records shall contain sufficientinformation to trace the distributed medicaldevice(s) and to permit a prompt and completewithdrawal of the device(s) from the market whenneeded.


Mandatory Mandatory documented procedures documented procedures yy ppHandling, Storage and Delivery of MDs

Th li t d di t ib t h ll l t bli h d t d- The listed distributor shall also establish a documented procedure for handling, storage and delivery of medical devices to fulfil the following requirements:devices to fulfil the following requirements:

(i) protection from environmental conditions that may affect the safety or performance of medical devices;y p ;

(ii) identification and appropriate storage, handling and deli er of medical de ices that req ire specialdelivery of medical devices that require special storage or transport conditions;

(iii) stock rotation (first-expiry first-out) for medical devices that have a limited shelf-life or expiry date;


Mandatory Mandatory documented procedures documented procedures yy ppHandling, Storage and Delivery of MDs

(i ) h dli f di l d i t t(iv) proper handling of medical devices to prevent damage, deterioration or contamination;

(v) identification, segregation and control of returned or recalled medical devices to prevent them from

/being inadvertently sold/issued; and

(vi) delivery procedures, including verification of orders(vi) delivery procedures, including verification of orders and physical inspection of label description, type and quantity of medical devices to avoid incorrect medical devices from being delivered/received.


Mandatory Mandatory documented procedures documented procedures yy ppStorage requirements:- The distributors shall also make reference to the

“Requirements on storage of Pharmaceutical Medical devices” from the website of Drug Office Department ofdevices from the website of Drug Office, Department of Health (web site: https://www.drugoffice.gov.hk/) where applicable for storage of the medical devices which pp gcontain pharmaceutical products and for those which have specific storage requirements of temperature and humidity. In general, there must be adequate storage facilities with appropriate measures in monitoring the storage temperature and humiditymonitoring the storage temperature and humidity.

- (http://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/Storage_requirements.pdf)


OthersOthersRequirements for Inspections make available to the MDCO for inspection, as soon as

possible, the distribution records (of devices including make model batch/serial number quantity expiry datemake, model, batch/serial number, quantity, expiry date, customer/delivery details) and other requested documents maintained by them; docu e s a a ed by e ;

allow the MDCO to perform inspection of the applicant’s/listed distributor’s premises and any related pp p ystorage and/or transportation facilities. The applicant/listed distributor must make provision for such i ti d id ll th i t tinspections and provide all the necessary assistance to the MDCO to facilitate the conduction of the inspections.


OthersOthersNotification of changes

N tif MDCO b t l t th 4 k- Notify MDCO asap but no later than 4 weeks after changes (such as contact details & di t ib t ti l )distributor particulars)

List of medical devices distributedsubmit a list of MDs during application in which- submit a list of MDs during application in which information on make, model, device description, and HKMD listing no (if applicable) should beand HKMD listing no. (if applicable) should be included


OthersOthers

Administrative Provisions - Validity of Approval: three years- Renewal of Listing: apply 6 months before expiryRenewal of Listing: apply 6 months before expiry

date

Retention period of records- not less than the lifetime of the MD, or seven

years from the date of product distribution, whichever is longer


OthersOthersSame as other Guidance Notes Requirements in Respect of Advertisement,

Promotional Materials, etc. Processing, Approval and Rejection of

Applicationspp ca o s Fees (free of charge)

Undertaking by Applicant Undertaking by Applicant Delisting of Distributors The List of Distributors


AppendicesAppendicespppp

Appendix 1 (Documented Procedures Required)Appendix 1 (Documented Procedures Required)- Describe essential content to be covered in each

procedure(such as Purpose, Scope, Roles and p ( p , p ,Responsibilities of persons, Detailed procedure and Records)

Appendix 2 (Sample documented procedures of pp ( p pa medical device distributor XYZ Co. Ltd.) Sample procedures for the distribution of medical devicesp p

(for illustration purpose)


Application FormApplication FormppppSimilar to the Application Form for Inclusion on the ppList of Importers (MD-IP)

Contains three parts:P ti l f A li t- Particulars of Applicant

- Applicant's Intent to distribute Medical Devices- Quality Management and Vigilance Practices


Application FormApplication FormppppPart I : Particulars of ApplicantppContains Company Name Company Name Address in Hong Kong

C t t I f ti Contact Information (Contact Person, E-mail, HK Telephone No., HK Mobile No. for urgent use (24 hours), HK Fax No.)


Application FormApplication FormppppPart II : Applicant's Intent to distribute MDsContains Details (MD Listing No., Make & Model) of listedDetails (MD Listing No., Make & Model) of listed

MDs Storage address (if different from Company Storage address (if different from Company

address) Full list of ALL MDs distributed & to be Full list of ALL MDs distributed & to be

distributed covering key information of each device including make, model, device description g , , pand listing no. of medical device (if applicable)


Application FormApplication FormppppPart III: Quality Management & Vigilance PracticesS b it f b l d t d dSubmits a copy of below documented procedures Keeping of distribution records Handling, storage and delivery of medical devices *Managing product alerts, modifications and recalls *Managing reportable adverse incidents in Hong Kong *Complaints handling *Tracking of specific medical devices *Maintenance and services arrangements

* (if applicable)


CommentsComments

For the draft GN youFor the draft GN you are welcome to sendare welcome to send

CommentsComments

For the draft GN, you For the draft GN, you are welcome to send are welcome to send your comments your comments to the Medical Device Control to the Medical Device Control Office by post, Office by post, email email or fax or fax on or before 31 on or before 31 y p ,y p ,December December 2014.2014.

Medical Medical Device Control Device Control OfficeOfficeWebsiteWebsite: www.mdco.gov.hk: www.mdco.gov.hkAddressAddress: Room 3101 31/F Hopewell Centre: Room 3101 31/F Hopewell CentreAddressAddress: Room 3101, 31/F, Hopewell Centre, : Room 3101, 31/F, Hopewell Centre, 183 Queen’s Road East, Wan Chai, Hong 183 Queen’s Road East, Wan Chai, Hong KongKongggEmail: [email protected] Email: [email protected] FaxFax: 3157 1286 : 3157 1286


Thank You! Thank You!


Supp infoSupp infopppp

Definitions of distributor overseas Definitions of distributor overseas Related definitions under MDACS What is GHTF and IMDRF? What is GHTF and IMDRF? What is AMDNS?


Definitions (GHTF)Definitions (GHTF)( )( )Distributor: (GHTF Final Document)http://www.imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n055-definition-terms-090326.pdf

means any natural or legal person in the supply chain who, on his own behalf, furthers the , ,availability of a medical device to the end user.

Notes: More than 1 distributor may be involved in the supply chain. o e t a d st buto ay be o ed t e supp y c a Persons in the supply chain involved in activities such as

storage and transport on behalf of the manufacturer, g pimporter or distributor, are not distributors under this definition.


Definitions (HC)Definitions (HC)( )( )

Distributor: (HC)Distributor: (HC)http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/directives/gui-0016-eng.php

is a person, other than a manufacturer, an importer or a retailer, who sells a medical device in Canada for the purpose of resale or use, other than for personal use. A person outside of Canada selling medical devices into Canada is also considered to be a distributor.


Definitions (MDACSDefinitions (MDACS))(( )) End user is an individual who purchases or

receives a medical device for one's ownreceives a medical device for one s own personal use or receives treatment or diagnosis with a medical device from a health care facility orwith a medical device from a health care facility or provider. Business party which purchases medical device(s) solelyBusiness party which purchases medical device(s) solely for use by its employees during work activities (e.g. first aid kits and disposable gloves) or for incidental emergency use is also considered as an end user as long as one is not in the business of offering healthcare service(s) to employees or other individualsservice(s) to employees or other individuals.

[follows HC; Re.: HC uses the name “Ultimate Consumer”]


Definitions (MDACS)Definitions (MDACS)( )( ) Person is a term that includes legal entities such

ti t hias a corporation, a partnership or an association. [GHTF’s definition]

Retailer is a person who supplies medical Retailer is a person who supplies medical device(s), or provides service utilizing a medical device, solely to the end user.device, solely to the end user.

[HC’s definition]


What is GHTF?What is GHTF?

GHTF (Global Harmonization Task Force) was formed in 1992 by a group of representatives from regulatory authorities & MD industry. The aim of the GHTF is to harmonize the standards & principles for the regulation of MDs. The founding members of the GHTF are the USA, EU, Canada, Australia, and Japan.

We recognise marketing approval certificates issued by these 5 founding members & our GNs and TRs, etc. are

ti ll d ll d th GHTF d tessentially modelled on the GHTF documents.


What is IMDRF?What is IMDRF? IMDRF is a voluntary group of medical device

regulators from around the world who have comeregulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force onof the Global Harmonization Task Force on Medical Devices (GHTF) and aims to accelerate international medical device regulatoryinternational medical device regulatory harmonization and convergence.IMDRF was born in October 2011 h t ti IMDRF was born in October 2011, when representatives from the medical device regulatory authorities of Australia, Brazil, Canada, China, European Union, Japan and the United States, as well as the World Health Organization (WHO) met in Ottawa to address the establishment and operation of this new Forum.


What is AMDNS?What is AMDNS?


Documents

Briefing Session on theBriefing Session on the Draft ...€¦ · Current Honggg g y Kong’s Regulatory Environment NO overarching legislation that regulates the manufacture,,p, import,