EMERGO SUMMARY OF KEY POINTS:

• Brazil’s ANVISA has published updated BGMP certification rules allowing for desktop reviews instead of on-site inspections.
• The new BGMP requirements apply to Class III and IV device registrants able to provide adequate technical documentation for review.
• A Normative Instruction from ANVISA is anticipated that will provide additional details on how the new BGMP certification process will work.

Brazilian medical device regulator ANVISA has published updated requirements allowing for quality management system certification for some higher-risk devices without on-site inspections.

As Emergo consultants in Brazil previously learned, ANVISA had proposed these changes to address a persistent Brazilian Good Manufacturing Practice (BGMP) inspection backlog. Proposed changes include implementing a risk-based quality system inspection regime, as well as start allowing “desktop reviews” of Class III and IV devices’ technical documentation in lieu of on-site facility inspections in order to certify BGMP compliance. Now, the regulator has published RDC 179/2017 (link in Portuguese) to bring these changes into force.

Three BGMP certification pathways

With the publication of RDC 179/2017, Brazilian market registrants now have three BGMP certification routes:

• On-site BGMP inspections by ANVISA
• Medical Device Single Audit Program (MDSAP) certification
• Desktop review of quality system and technical documentation in lieu of on-site inspections

BGMP inspection changes now apply to all new and in-process inspection requests. A planned ANVISA  Normative Instruction guidance document should clarify specific documentation requirements and related issues.

Additional ANVISA and Brazilian GMP resources from Emergo:

• ANVISA medical device registration consulting
• BGMP implementation and compliance support
• ANVISA medical device classification consulting
• Whitepaper: Brazil’s medical device registration process
• Whitepaper: BGMP requirements for medical device companies