Brazil GMP (BGMP) Quality System Compliance

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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 starting May 22, 2010. ANVISA conducts inspections of domestic and foreign medical device manufacturers to determine compliance with Brazil GMP regulations. Upon successful completion of an audit, ANVISA will then issue the GMP certificate, which is necessary in order to register a medical device in Brazil for some products. For more details on the ANVISA approval process, see our regulatory chart.

Brazil's GMP regulations most closely resemble the internationally recognized ISO 13485 standard.

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Compliance with Brazilian GMP requirements

Emergo Group maintains an office in Brazil and we can fully assist you with modifying your existing US FDA GMP or ISO 13485 compliant quality management system to meet Brazil GMP requirements. In addition, our medical device consulting team in Brazil has experience with a wide range of devices.

Whether you are entering Brazil for the first time or introducing a new device, Emergo Group has in-depth knowledge of the Brazilian regulations with the added benefit of a local consulting team in Brazil.

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

Commonly Asked Questions: 
What kind of products require ANVISA Good Manufacturing Practices inspection, will my company need this?
All Class III and IV medical devices require an inspection of the relevant manufacturing sites. As a shorthand, Brazil Class III and IV products are generally aligned to Europe Class Class IIb and III devices. However, some Class I and II devices also require GMP inspection. To find out if your Class I or II device requires GMP inspection, you can consult Brazilian Normative Instruction (IN) 2/2011. See our list of Brazilian Medical Device Regulations.  
 
I have heard that ANVISA allows third party organizations to audit to B-GMP. Is this true?
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. This auditing program is intended to be an additional option for companies which require B-GMP quality management system inspections; the “normal” process of receiving inspections directly from ANVISA will continue to be available.