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Brazil GMP (BGMP) Quality System Compliance

Answered on this page:
  • Who needs to comply with BGMP?
  • Do Class I and II devices require BGMP?
  • Which device manufacturers will ANVISA inspect?
  • Will an existing ISO 13485 certificate be acceptable?

Companies that want to sell medical devices or IVD products in Brazil must comply with Brazilian Good Manufacturing Practice (GMP) quality system requirements. The requirements for medical devices are specified in Brazilian resolution RDC 16/2013.

In 2009, Brazil's regulatory agency (ANVISA) issued a resolution, RDC 25/2009, that made Brazilian GMP certification mandatory for many medical device manufacturers. With ANVISA’s release of RDC 15/2014, B-GMP certification is only required for manufacturers of Class III and IV medical and IVD devices.

B-GMP inspections prior to registration approval

Brazil's GMP regulations most closely resemble the internationally recognized ISO 13485 standard, and similar to Europe, ANVISA conducts inspections of medical device manufacturers to determine BGMP compliance. ANVISA will only approve device registrations after successful completion of a BGMP audit. For more details on the ANVISA approval process, download our regulatory chart

Compliance with Brazilian GMP requirements

With offices in Brazil and worldwide, Emergo has expertise with a wide range of quality management systems including FDA QSR, ISO 13485, Japan Ordinance 169. As a result, we know how to upgrade your existing QMS to comply with Brazilian GMP requirements.

  • We can modify your existing QMS to meet Brazil’s GMP requirement.
  • Our in-depth knowledge of the Brazilian regulations ensures that your quality systems will be up-to-date.
  • We have experience assisting hundreds of manufacturers with BGMP compliance, ANVISA registration and other regulatory consulting services.

Please contact us for more information on achieving on Brazilian GMP compliance for your company.

Ask us for detailed information about Brazil BGMP compliance services.

Learn about the process, costs and timelines.

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Listen to our 12 minute podcast interview on QMS compliance in Brazil:

Interested in learning more about QMS requirements in Brazil? Emergo's Ann Marie Boullie, Vice President of Business Development, and Tatiana Sell, International Projects Manager, discuss some of our most frequently asked B-GMP questions in this podcast interview.


Frequently Asked Questions

What products require ANVISA Good Manufacturing Practices inspection?

Companies registering any Class III or IV medical device in Brazil will require an inspection of their relevant manufacturing sites before ANVISA will approve the registration. In Brazil, Class III and IV products are generally aligned to European Class IIb and III devices.

Can I submit my ISO 13485 certification to meet BGMP requirements?

Yes and no. Yes, you can use your ISO 13485 certificate to temporarily meet BGMP requirements for purposes of having your registration reviewed by ANVISA, thus bypassing a lengthy BGMP inspection queue. However, you will still need to get inspected by ANVISA eventually for BGMP compliance. If you fail that inspection, they can revoke your registrations.

Do Class I and II devices require BGMP certification?

No. In 2014, ANVISA released RDC 15/2014 which exempted Class I and II devices from requiring B-GMP certification. While this means thatClass I and II medical device and IVDs can submit their registration without any onsite quality system certification, they still must comply with additional QMS requirements according to Brazilian legislation.

Does ANVISA allow third party organizations to audit to BGMP?

Not at this time. However, Brazil is a member of the International Medical Device Regulators Forum (IMDRF) Medical Device Single Audit Program (MDSAP) working group, along with Canada, Australia and the USA.