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 the their relevant manufacturing sites before ANVISA will approve the registration. In Brazil, Class III and IV products are generally aligned to European Class IIa, 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.