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São Paulo, Jan 23rd 2017
T H E B R A Z I L I A N E N V I R O N M E N T F O R M E D I C A L D E V I C E S
• Overview Healthcare structure in Brazil
• Healthcare and Medical Devices Market
• Steps to enter the Brazilian Market
• Industrial policies in Brazil
• Highlights of Anvisa’s regulations
• Conclusions
• ABIMED in few words
A G E N D A
H E A LT H C A REE N VI RON ME N T
H E A L T H C A R E S T R U C T U R E
Brazilian Constitution
• “Access to healthcare is a right of the citizen and a duty of the State” (Art. 196)
• “Healthcare assistance is open to private enterprise”(Art. 199)
MINISTRY OF HEALTH
Responsible for the execution of health policy
ANVISA National Health Surveillance Agency) Independent; Power to regulate and control
SCTIESecretariat of Science, Technology and Strategic Materials
SAS Secretariat of Healthcare Assistance
ANSNational Agency of Supplemental HealthcareRegulates the private sector -HMOs (Health Medical
Organizations)
CONITECNational Commission for implementing new technologies at SUS
TOTAL EXPENDITURE ON HEALTH (9,5% OF GDP)
R$ 563.1 bi
PUBLIC HEALTH (45.2%)R$ 254.8 bi
PRIVATE HEALTH (54.8%)R$ 308.3 bi
Federal (36.0%)
R$ 91.7bi
State(28.4%)
R$ 72.5 bi
Municipal(35.6%)
R$ 90.6bi
Supplementary Healthcare
(46.7%)R$143.9 bi
Out-of-pocketexpenditures
(53.3%)R$164.5
Source: ANAHP 2015
• 6,300 hospitals (70 % private)
• 494,740 hospital beds
• 95,990 supplementary healthcare services
• 432,523 physicians
• 2,58 million other healthcare professionals
• 143,998 dentists
• 70,000 drugstores
Source: CNES, CFM Jan 2015
B R A Z I L I A N H E A L T H C A R E F I G U R E S
P O P U L A T I O N P Y R A M I D
Source: ANAHP / IBGE
11,3 % of elderly population (60 years old or +)
23 million 41,5 million
18,6 % of elderly population (60 years old or +) Brazil2014 to 2030
Geography• Area 8.514 million km²• Cities 5,560 cities• Coastline 7,500 km
Population - 2015• Inhabitants 204 million• Growth rate 1,7% per year• Life expectancy 71.9M/79.1 W • Illiteracy 8.3% (>15y)
Economy• GDP US$ 2.347 bi (2015)• GDP per capita US$8,651(2015)• Inflation rate 6.3%% (2016)• Basic interest rate 13.0% (Jan 2017)• GDP growth -3,8% (2016)• Unemployment rate 12,0% (2016)• Export US$185.2bi (2016)• Import US$137.7bi (2016)
Sources: IBGE, BC, Copom, PNAD
A C O U N T R Y O F C O N T R A S T S
ME DI CA L DE VI CE S
M A RK E T I N BRA ZI L
MEDICAL DEVICES - GLOBAL MARKET (2014)
Source: USITC and Saúde 4.0 ABIIS 2015
90Categories
10kTypes Items
500k80%
SME< 50
Employees
Global Market
US$ 350bi
Total Export
US$ 177,7bi
Source: USITC (2014) and Saúde 4.0 ABIIS 2015
GLOBAL EXPORT (COUNTRY OF ORIGIN)
40%5%
5%
5%
9%
13%23%
OthersBelgium
Switzerland
China
Netherland
Germany
USA
Manufacturers
4 032 10450
14482
71 194
Employees
132642
US$ 10,7 bi
Production + (Import – Export)
TOTAL HEALTH EXPENDITURE
US$ 291,3 bi
Source: Websetorial
32% (SP)
Manufacturers Commercial
2,8%Commercial
61448
Enterprises
MEDICAL DEVICES – BRAZILIAN MARKET
28%USA
15%Germany
9%Switzerland
8%China
4%Japan
3%France
3%Malasia
3%UK
3%Italy
24%Others
ORIGINS OF BRAZIL IMPORTATION ( 2014)
Fonte: SECEX – Alice WEB e Saúde 4.0 ABIIS 2015
Fonte: Websetorial para ABIIS e Saúde 4.0 ABIIS 2015
20%
Reagents for In Vitro Diagnostics
M A R K E T S E G M E N T A T I O N
14%Laboratory equipment
2%Hospital furniture
19%
Supply materials
15%
Orthosis & prosthesis3%Dentistry equipment
19%Other hospital equipment
8%Diagnostic imaging & supplies
Medical Devices Brazil
Fonte: SECEX – Alice WEB/PIA Produto - IBGE e Saúde 4.0 ABIIS 2015
A m o n g t h e g r o u p s o f i m p o r t e d p r o d u c t s f o r h e a l t h , t h e l a r g e s t B r a z i l i a n d e p e n d e n c e o c c u r s i n r e a g e n t s f o r i n v i t r o d i a g n o s t i c
Hospital materials &
supplies
Orthosis & Prosthesis
Dentistry equipment
Other hospital equipment
Imaging equipment &
supplies
Laboratory equipment
Reagents for in vitro diagnostics
Furniture
49%46%
13%
63%
49%
37%
78%
23%
S T E PS TO E N T E R T HE BRA ZI L I A N MA RK E T
• Law 6360/1975 – Sanitary Surveillance
• RDC 185/2001 – Classes of Risk – Registration/Notification process
• Law 9.782/1999 – Foundation of Anvisa
• Anvisa has a robust and comprehensive regulation for pre and
post market
• Anvisa is member of IMDRF – International Medical Devices
Regulators Forum
Source: CNES, CFM Jan 2015
M A I N L A W S A N D R E S O L U T I O N S
• Be officially represented in the country
• Have Anvisa authorization for commercialize
• Have a technical responsible
• Notify or register the product
• Notification: Products of Risk classes I and II
• Registration: Products of Risk classes III an IV
• Classes III and IV require GMP Certificate of the factory
• Factory inspection may be outsourced through MDSAP
• Some products may require product certification
• Registration is valid for 5 years (it will extended up to 10 years)
• Notification just once
• Focus on post-market activities
Source: CNES, CFM Jan 2015
M A I N S T E P S
I M D R F
• Members: Brazil, USA, UE, Australia, Japan, Canada, China and Russia
• Active working groups – e.g. MDSAP, UDI, RSP, NCAR, SaMD
BRA ZI L I A N I N DU S T RI A L
POL I CI E S
H O W B R A Z I L I A N I N D U S T R I A L P O L I C I E S C O N T R I B U T E T O R & D
MINISTRY OF HEALTH POLICIES
• PDP – Partnership for Productive DevelopmentTechnology transfer x governmental procurement
• Offset model – e.g.: Linear accelerators for radiotherapy
MDIC AND MCTI POLICY
• PPB – Basic Productive Process e.g.: Imaging products
H I G H L I G H T S O F A N V I S A ’ S R E G U L A T I O N S
• Law 13.043/2014
• No renewal of AFE
• Good Manufacturing Practice (GMP) validity up to 4 years (to be
regulated by Anvisa)
• Law 13.097/2015
• Registration: Validity timeframes for some devices may be increased
to up to 10 years depending on product characteristics and risks;
• Inspections for GMP may be outsourced: ANVISA adopted MDSAP
• ANVISA may expand certifications of laboratories authorized to
conduct health surveillance inspections and post-market
surveillance.
Note: ANVISA will need to release additional regulations in order to define
and implement the allowances made in the law.
A BI ME D I N F E W WORDS
• Founded in June 1996
• 220 members
• 65% of Market share
• Code of Conduct since 2006
• Partnering with national & international
• INTERFARMA, ABIMO, CBDL, ABRAIDI, SINDUSFARMA
• GMTA, DITTA, ALDIMED, ADVAMED
• Member of Institute Health Coalition
• Member of Institute Ethic-Health
A B I M E DB R A Z I L I A N A S S O C I A T I O N O F H I G H T E C H N O L O G Y I N D U S T R I E S O F M E D I C A L D E V I C E S
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