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.