Answered on this page:
- Who needs to comply with BGMP?
- Which device manufacturers will ANVISA inspect?
- Will an existing ISO 13485 certificate be acceptable?
Companies that want to sell Class III and IV medical devices or IVDs in Brazil must obtain Brazilian Good Manufacturing Practice (BGMP) certification. The requirements for medical devices are specified in Brazilian resolution RDC 16/2013 and are similar to FDA Quality System Regulation (21 CFR part 820) and ISO 13485 requirements, with some notable differences.
B-GMP inspections prior to registration approval
In order to be in compliance with Brazil's requirements, you must submit a GMP Certificate with your Class III or IV registration. GMP certification requires an inspection by ANVISA, which could include an off-site review of your QMS documentation or an onsite inspection of your manufacturing facilities. ANVISA will only approve device registrations after successful completion of a BGMP audit.
BGMP inspection requests for foreign manufacturers must be submitted by your Brazil Registration Holder (BRH), who will then be the owner of the certificate issued by ANVISA. For more details on the ANVISA approval process, download our regulatory chart.
Emergo can help you comply with Brazilian QMS requirements
With offices worldwide and two locations in Brazil, we know how to upgrade your existing QMS to comply with Brazilian GMP requirements. We have experience assisting hundreds of manufacturers with BGMP compliance, ANVISA registration, and other regulatory consulting services. Here's how we can help:
- Complete a thorough gap assessment to evaluate your current level of compliance.
- Help modify your existing QMS to meet Brazil's GMP requirement.
- Perform on-site mock audit in preparation for your BGMP inspection.
- Provide on-site support during ANVISA's inspection of your quality system.
Emergo has experience with a range of quality management systems requirements, including FDA QSR, ISO 13485, and Japan Ordinance 169. We can help with QMS compliance in Brazil and worldwide.