Latest update Brazil Regulations By S. Jaime - Qserve Group (Qserve Conference 2013)

Page 1 | 2011 |Copyright Qserve Group B.V.

The regulatory road to market The regulatory road to market

Brazil Regulations Update Q s e r v e C o n f e r e n c e 1 8 - 1 9 N o v e m b e r 2 0 1 3

P u r m e r e n d – G r e a t e r A m s t e r d a m

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Agenda

• Geography

• Key developments in Brazil

• Health care system

• Regulatory process for medical devices in Brazil

• Validation compliance

• Additional remarks

• Summary/main conclusions

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Geography

• Brazil is largest country in South America, 5th largest in the world

• Population of 200 Million 5th largest worldwide

• Capital is the city of Brasília, main cities are:

São Paulo ( 11 Million citizens )

Rio de Janeiro (6 Million citizens)

• Brazil is ruled by the Federal Presidential Representative Democratic Republic

• 6th largest economy in 2012. GDP : US $ 12.800 , growth: 2,34 % ( Netherlands: US $ 42.300,-)

Key developments in Brazil

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Key developments in Brazil

Strengths

• Positive economic conditions in the recent years.

• Increased consumption power by C/D class. • Low risk country (ranked as 3rd most

attractive country for foreign investment). • Adaptability, creativity and flexibility.

Weaknesses

• Empire of laws / heavy bureaucracy, enormous public spending.

• Corruption incentive due to customs , tax & legal system.

• Regional inequalities. • Structural barriers to growth.

Opportunities

• Economic development forcing reforms. • FIFA World Cup in 2014, Olympic Games in

2016 and Pre Salt development (Brazil as the 6th world major oil reserve) will ramp investments in infra-structure.

• World player ambitions demand open economy.

• Brazil will be the China (GDP growth velocity) of the next decade (2010-20), becoming the #5 world’s economy.

Threats

• Possible Global Recessions. • Low pace of reforms bottlenecks economic

growth. • China dependency.

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Health Care System in Brazil

• Largest medical device market in Latin America.

• The public health system (SUS), provides healthcare services for all Brazilians citizens

• The majority of inpatient services within the SUS are operated by private providers, with more than two-thirds of hospital facilities operated by the private sector.

• Brazil has the second largest private health insurance sector in the Americas, after the USA, covering around 25% of the population

• The expansion of the private health insurance sector in recent years has resulted in demand for better medical care and, in turn, further expenditure in medical equipment.

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Health Care System in Brazil

• Private investment being encouraged through a public-private partnerships

• Public sector continues to be modernized and to upgrade

• The government is extending healthcare service access through its Mais Saúde

programme.

• Invest in SUS expanding: 2013: Reais 2.3 billion (US$1.1 billion) to support the

development of primary health and emergency care services.

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The development of the economy is forcing reforms to improve and provide a good

health system to all people covering the whole country and not only the major

economic centers as Sao Paulo and Rio de Janeiro.

Health care system in Brazil

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Regulatory process for medical devices in Brazil National Health Surveillance Agency

National Institute of Metrology,

Standartization and Industrial Quality

Registration of medical devices and

maintenance of a registered products

database Brazilian GMP audit

National accreditation body. Some electronic medical devices must obtain INMETRO certification as part of the Brazilian registration process.

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Regulatory processes in Brazil

Medical Device Classification – RDC 185/01 is the primary regulation applicable

to the registration of all medical devices, risk based classification, subdivided in

four classes similar to the Annex IX 93/42/EEC

RDC No. 185 describes the applicable device registration protocol and lists the

documents required to legally register a medical device in Brazil.

Early classification of medical devices required

RDC 185/01 93/42/EEC, Annex IX

I I

II IIa

III IIb

IV III

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Appoint Brazilian Registration Holder

Who you can use to be your BRH?

Regulatory processes in Brazil

set up your own company

use a distributor

use an independent firm

Responsibilities of BRH • Provide authorization as local entity

on the device registration to Anvisa • Request the GMP inspection, if

applicable • Submit GMP self-inspection reports, if

applicable, to Anvisa • Hold INMETRO certificates • Give permission for distributors to

import products • Coordinate inquiries, analysis and

response for reportable events and recalls

• Assist in renewal and modifications of device registrations

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Regulatory processes in Brazil ANVISA´s GMP INSPECTION

Manufacturer must submit application for ANVISA´s GMP inspection

Payment of fee in advance: R$ 37.000,00 (approximately US $ 16.500,00) per

site

New regulation: Publication of RDC 16/13 covering ANVISA´s GMP

requirements for Medical Devices and IVDs

RDC 16/13 replaces RDC 59/00 and Portaria 686 (IVDs)

GMP inspections are mandatory for manufactures of class III and IV devices

and class I/II devices listed in IN2/11

Once GMP compliance has been established, ANVISA conducts GMP

inspections every two years.

Manufacturers must self-audit every alternating year and submit report to

Anvisa

ANVISA registrations are valid for five years.

Audit are currently only performed by ANVISA – no Third Party authorized

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Regulatory processes in Brazil ANVISA´s GMP INSPECTION

• Queue time for Anvisa´s GMP inspection is currently about 2 years

• After successful inspection, Anvisa issues an Inspection Certificate which is

prerequisite for later medical device registration

• Manufactures of Class I and II devices not listed in IN 2/11 are exempt from

Brazilian GMP inspections

• Market access according to the Cadastro Process RDC 24/09

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Regulatory processes in Brazil - INMETRO Certification

INMETRO Exemptions

Medical devices for which no test

capabilities within Brazil are available

such as Magnetic Resonance Devices

and Computer Tomography Scanner

Mandatory INMETRO certification

for most electrical Medical

Devices under the scope of

standards as listed in IN 3/11 -

mostly similar IEC or ISO

standards

Some none electrical medical

devices

e.g. Gloves, Male Condoms, infusion

sets, needles , syringes

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Regulatory processes - INMETRO Certification

Test report must not be older than 2 years – Ordinance 350/10

After successful completion of Documentation Review and Pre-license Inspection, certification is accepted

Must be completed prior to registration at ANVISA – RDC 27/11

Annual factory inspection in order to maintain INMETRO Certification

INMETRO Certifications is valid for 5 years

For Re certification after 5 years, the Medical Device has to be completely re-tested even if it has not been changed

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Prerequisites

ANVISA´s Inspection Certificate

INMETRO Certificate – if applicable

Complete set of documentation according to RDC 185/01

Content of documentation according to RDC 185/01

Registration Form

Instructions for use in Portuguese

Technical Report: technical and scientific data regarding device safety

Manufactures letter authorization for a Brazilian legal entity to register, import and distribute the product

Manufacturing Description - Flow Chart

Regulatory processes – Anvisa Registration

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Clinical Data, can be clinical trials or literature depending on the risk

Proof of home market approval / Free sales Certificate

Alternatively proof of two other marketing approvals and explanation for no

home market approval

List of all accessories

Economic Information Report can also be required for some medical devices,

(cardiovascular products, implantable medical devices), information about

lifetime, pricing in other markets, number of patients per year – RDC 185/06

Specific documentation regarding the device can also be requested by ANVISA

Regulatory processes – Anvisa Registration

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Manufactures of Class I and II devices not listed in IN 2/11 - RDC 24/09

Registration Form

Technical Report

Payment of fee

Timeline: approx.. 3months

Regulatory processes – Anvisa “Cadastro”

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Timelines

Lead Time Anvisa Inspection up to 24 months

Time between application for GMP Inspection and execution of inspection / issuance of certificate

by Anvisa

Anvisa Review Time up to 12

months

(depending on classification, risk,

complexity of product)

INMETRO Certification About 1/2 month's

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Additional remarks

Brazilian medical device market regulator ANVISA plans to launch a two-year trial period to allow third-party audits of Brazilian Good Manufacturing Practice (B-GMP) quality systems.

ANVISA has set a tentative start date of January 2014 for the trial; the US, Canada, Brazil and Australia are expected to participate, meaning that third-party certifiers would be able to audit a manufacturer’s quality system for US, Canadian, Brazilian and Australian requirements at the same time.

Although third-party inspectors will be able to perform B-GMP audits, they will not issue B-GMP certificates. The inspectors will instead provide reports to ANVISA, and the regulator will then issue final certification to the manufacturer in question.

This auditing program is intended to be an additional option for companies that require B-GMP quality management System inspections; the “normal” process of requesting and receiving inspections directly from ANVISA will continue to be available

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Validation compliance Brazil

• A new Good Manufacturing Practices regulation, RDC 16/2013, replaces two prior BGMP resolutions, RDC 59/2000 for medical devices and Ordinance 686/1998 for in vitro diagnostic (IVD) devices

• Classification has impact on timeline: Complete registration process or cadastro

• When applying for ANVISA GMP Inspection, the time on line has to be considered

• ANVISA has published RDC 39/2013, issuing GMP certificates as well as Certifications of Good Distribution Practices.

• In addition, RDC 39/2013 allows foreign companies to change addresses of facilities listed in applications for GMP certification, provided their applications have not yet been reviewed by ANVISA.

• INMETRO Safety certification for medical devices with electrical and other components has changed in Brazil.

• Foreign manufactures in the process of appointing BRH partners for devices that must undergo INMETRO testing and certification should therefore verify that any potential in-country representation partner can properly obtain INMETRO certification as well as manage ANVISA registration

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Summary/main conclusions

• Current size and anticipated continued growth of the Brazilian market present significant opportunities for manufacturers of medical devices.

• The length of time between filing an application for a registration of a medical device and the final government approval can be lengthy.

• Medical device manufacturers can ease the process of gaining access to this lucrative market by understanding the similarities and differences between Brazil’s medical device approval scheme and the ones used in other major markets. Staying informed of anticipated changes in regulations provide valuable time to develop alternative plans and strategies for gaining and maintaining market access.

• Finally, working with an experienced and knowledgeable company in Brazil can smooth the compliance process and mitigate setbacks from unanticipated issues and challenges.

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Thank you for your attention !

S h e i l a J a i m e s h e i l a . j a i m e @ q s e r v e g r o u p . c o m

www.qservegroup.com Qserve Group B.V.

Asterweg 19 D12 1031 DL Amsterdam

The Netherlands T +31 (0)20 78 82 630

E [email protected]