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B-GMP

ANVISA in Brazil

Submitted ANVISA Brazil Registrations Medical devices in Brazil are regulated by the Agência Nacional de Vigilancia Sanitária (ANVISA). Brazil’s base regulations and medical device classification schemes are similar to European MDD 93/42/EEC.

Classification

Lower risk: “Cadastro registration” route, includes a simplified application

Higher risk: “ Registro registration “process.

Submitting

Cadastro registration route:

An application, Legal Documents, Proposed Labeling and IFU to BRH (for ANVISA audit)

Registro route:

Technical File (clinical data/clinical studies/Legal documents/IFUs/proposed labeling) and additional device information in accordance with Annex III Part A, B or C of RDC 185/01 and submit to ANVISA.

Brazilian Registration Holder (BRH)

Foreign medical device manufacturers located outside Brazil must appoint a Brazilian Registration Holder (BRH).

--Submit registration application to ANVISA

--Maintains control of device registration and Brazil Good Manufacturing Practice (BGMP) certification

INMETRO Certification

Active Medical Devices subject to IEC 60601 need to obtain National Institute of Metrology, Standardization and Industrial Quality (INMETRO) certification from an authorized local certifier in Brazil. 

ANVISA approval normal Cycle

(Depends on device type)

Class I, II: Cadastro application, 1 to 7 months.

Class I, II: Registro application, 6 to 12 months.

Class III, IV: Brazil GMP certificate required, the approval timeframe could be up to 4 years due to ANVISA’s backlog. (ANVISA registration technical file preparation and translations excluded)

Registration Certificate Transference

 (According to Brazilian Resolution RDC 22/2010)

-- ANVISA does not allow transfer of a registration in most cases

--Registrations can only be transferred when: merger, spinoff, incorporation or succession of the BRH.

--Transfer of a registration is not allowed in case of distributors switching.

Brazil Good Manufacturing Practice (BGMP)

Class III and IV MD /Class II, III and IV IVD products sold to Brazil must comply with Brazilian Good Manufacturing Practice (GMP) quality system requirements, as specified in Brazilian resolution RDC 16/2013 for MD.

B-GMP inspections before Registration approval

ANVISA inspects MD manufacturers to determine BGMP compliance, no approval for device registrations without BGMP audit. 

ISO 13485 Certification & BGMP Requirements

--ISO 13485 certificate can be used for temporarily meeting BGMP requirements for ANVISA registration;

--BGMP inspection should be supplemented even with ISO13485 Certificate; registrations can be revoked if inspection fails.

What We Do?

--Gap analysis audit

--Pre-assessment audit

--Full or partial internal audit

--Subcontractor or supplier audit

--Document and records control

--Training on regulatory requirements and internal procedures

--Design and development

--Risk management

--Software development (if applicable)

--Supplier evaluation

--Control of measurement equipment

Why Jiushun Management?

Jiushun Management, focused on Medical Device Registration, Certification for 20 years, provided high quality service for more than 5,000 global customers.

The MD industry focus degrees, regulatory familiarity, and rich experience, determine our high efficiency and professionalism.

Our professional technical support, from the early regulations, processes guidance, documentation preparation, to testing assistance, review tracking, as well as years of MD industry resource integration, will greatly shorten the period of your product approval, and well practice our principle "Jiushun Management, create value for you. ".

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