What is B-GMP?

B-GMP stands for Brazilian Good Manufacturing Practices, the standards set by the National Agency of Health Surveillance (ANVISA), the Health Agency regulating the medical devices in Brazil. All medical device manufacturers marketing their devices in Brazil shall comply with the resolutions RDC 16/2013, the BGMP regulations.

Do all devices require a B-GMP Certificate?

As per the resolution RDC 15/2014, medical devices and in-vitro diagnostic devices falling under Class III and IV should comply with the B-GMP regulations and shall possess the Brazilian Good Manufacturing Practice (B-GMP) certificate for approval and commercialization of devices in Brazil. Class I and Class II devices are exempted from the B-GMP certification, but they must comply with the medical device GMP requirements set by the Brazilian agency.

The Normative Instruction 8/2013 requires that the manufacturers ensure that the stakeholders (such as importers and distributors) comply with the medical device GMP requirements that are relevant to them. In case of an original equipment manufacturer (OEM) or contract manufacturing business models, the Resolution RDC 183/2017 requires that the legal and contract manufacturers of final products or SaMDs and the site that releases the final product are required to have B-GMP certificates.

How can one obtain a B-GMP Certificate?

The Resolution RDC 183/2017 provides administrative procedure to grant ANVISA GMP certificate to device manufacturers, to be used for device registration. ANVISA may issue the medical device GMP certification (B-GMP  Certificate) under any of the below situations, only after a thorough assessment of submitted documents:

• Manufacturer presents a valid audit report issued under the ANVISA recognized programs such as Medical Device Single Audit Program (MDSAP)
• Manufacturer presents a valid B-GMP audit report issued by the IMDRF member country or the auditing authorities accredited by these member countries
• Manufacturer presents a valid audit report issued by the ANVISA recognized third party auditing organizations
• Manufacturer submits inspection reports issued by the Health Authorities of other countries under certain agreements
• ANVISA performs a detailed risk analysis to assess the need for an on-site inspection before granting the B-GMP. The risk analysis is based on device risk, indication of use, device technology and complexity of the manufacturing process

Prior to the release of Resolution RDC 183/2017, the ANVISA suggests that all foreign manufacturers to undergo on-site inspection for issuing a B-GMP certificate.

How can one leverage MDSAP Certification?

As a member of MDSAP, ANVISA grants B-GMP certificates after analyzing the audit reports issued by Auditing Organizations that are accredited under the MDSAP program. The reports should comply with the Brazilian regulations - RDC 16/2013. MDSAP should provide a surveillance report in special circumstances. ANVISA does not issue any Brazilian GMP certification to the manufacturing sites with Grade 4 and 5 Non – conformities. However, the sites with grades 1-3 non-conformity have to provide a detailed action plan to obtain the B-GMP certificate.

Given below are the statistics of B-GMP certificates issued by leveraging the MDSAP certificates issued through MDSAP program and those issued after an on-site inspection by the ANVISA.

It is inferred from the above statistics that the ANVISA is relying on MDSAP program for issuing the MDSAP certification.

What is the process for applying for a B-GMP Certificate?

The process for obtaining a B-GMP certificate is detailed below -

• Request has to be made by Brazilian Registration Holder (BRH) for B-GMP certification
• BRH can submit the certificates issued by the MDSAP or audit reports issued by the third-party authorized organizations
• ANVISA evaluates the reports issued by the MDSAP and other organizations, after the assessment the Agency issues a B-GMP certificate
• The obtained B-GMP certificate is submitted to the ANVISA along with the device dossier file for device registration
• Once the registration is completed, approved medical devices are legally commercialized in the Brazilian market

What are the documents to be submitted for B-GMP Certification?

The Brazilian Registration Holder (BRH) shall submit a request for B-GMP certificate on the manufacturer’s behalf. The request should include –

• A Duly filled B-GMP certification request form. The form is available on the ANVISA’s official website and requires the manufacturer to include device and manufacturing site information
• Proof of payment of B-GMP certification
• Quality manual
• List of devices produced at the manufacturing site in scope and the indication of devices intended to be exported into the Brazilian market
• Manufacturing process flow chart
• Manufacturing site layout
• INMETRO Certificate in case of electromedical devices
• Marketing information of the devices in scope – the countries to which the devices are exported and the evidence of registration in these countries
• List of all inspections in the past three (3) years along with the details of non-conformities or Regulatory actions
• Copy of the most recent audit report from the respective Health Agency of country of origin
• Copy of the most recent audit report issued by the IMDRF country or the auditing organization accredited by these countries or the third party auditing organizations recognized by the ANVISA

What is the validity of a B-GMP Certificate?

The B-GMP certificate, issued by ANVISA, after a detailed scrutiny,  is valid for two (2) years and it shall be renewed once in every two (2) years. Each Brazil GMP certificate is specific to a BRH-manufacturer. A manufacturer appointing a new BRH for a different product shall obtain another B-GMP certificate, to be requested by a new BRH.

Therefore, to market the medical devices in the Brazilian market, manufacturers must be aware of the here above mentioned B-GMP certification process set by the ANVISA. Are you looking for a BGMP certification for your medical device? Seek a Regulatory expert’s assistance right now.