Answered on this page:
- Who needs to comply with B-GMP?
- 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 Brazil Good Manufacturing Practice (B-GMP) certification. The requirements for medical devices are specified in Brazilian Resolutions RDC 16/2013 and RDC 39/2013 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 B-GMP audit.
B-GMP 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, log in to RAMS to consult our regulatory chart.
Emergo by UL 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 B-GMP 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 B-GMP inspection.
- Provide on-site support during ANVISA's inspection of your quality system.
Our expertise in QMS requirements, including ISO 13485 standard for medical devices
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.
Emergo by UL can provide eQMS support in strategic alliance with Greenlight Guru. This helps you leverage an eQMS system designed specifically for the medical device industry. Ask us to schedule a demo so you can explore a software solution that connects with your processes, people, and data.
Common Brazil GMP questions
Can I submit my ISO 13485 certification to meet B-GMP requirements?
Yes and no. Yes, under certain circumstances, you can use your ISO 13485 certificate to temporarily meet B-GMP requirements to have your registration reviewed by ANVISA, and bypass a lengthy B-GMP inspection queue. Ask Emergo by UL more about this. However, you still need an ANVISA inspection for B-GMP compliance. If you fail that inspection, ANIVSA can revoke your registrations.
Do Class I and II devices require B-GMP certification?
Class I and II devices are exempt from B-GMP certification. They can submit their registration without any on-site quality system certification, but they must still comply with additional QMS requirements according to Brazilian legislation.
Does ANVISA allow third party organizations to audit to B-GMP?
As a member of MDSAP, Brazil allows B-GMP audits by authorized auditing organizations. Proof of MDSAP certification is provided to ANVISA, and ANVISA will issue the B-GMP certification.
So, while the MDSAP certification doesn't REPLACE the B-GMP certificate, the MDSAP audit can take the place of a B-GMP audit. Note that if you use MDSAP audit, you must still pay ANVISA's B-GMP fee in addition to the MDSAP auditing organization's fee.
Can we accelerate our B-GMP inspection?
Some medical device manufacturers with foreign QMS certifications (such as ISO 13485) can submit their device applications before completing the B-GMP inspection. To qualify for this exception, you must submit through a member of ABIMED (Emergo is a member) and you must submit proof that you have been waiting six months or longer for your GMP inspection, plus proof of other quality system certification.
Within the UL family of companies we provide a broad portfolio of offerings to all the Medical Device industries. This includes certification, notified body and consultancy services In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our Brand and our customers brands UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality.