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Compliance Audit Checklist in Brazil: What You Need to Know
São Paulo, Brazil - For companies seeking to sell Class III and IV medical devices or IVDs in Brazil, obtaining Brazil Good Manufacturing Practice (B-GMP) certification is a must. The requirements for medical devices are specified in Brazilian Resolutions RDC 665/2022 and RDC 497/2021, which are similar to FDA Quality System Regulation (21 CFR part 820) and ISO 13485 requirements.
Who Needs to Comply with B-GMP?
Companies that want to register their Class III or IV medical devices with ANVISA, the Brazilian health regulatory agency, must submit a GMP Certificate along with their registration application. This certificate requires an inspection by ANVISA, which could include a review of quality management system (QMS) documentation or an onsite inspection of manufacturing facilities.
Foreign Manufacturers: ANVISA Inspection Requests
For foreign manufacturers seeking to register their devices in Brazil, the process involves submitting an inspection request through their Brazil Registration Holder (BRH), who will then own the certificate issued by ANVISA. The BRH is responsible for ensuring compliance with B-GMP requirements and submitting the necessary documentation to ANVISA.
Compliance with Brazilian QMS Requirements
To help companies comply with B-GMP requirements, Emergo by UL offers a range of services:
Compliance Support Services
- Conducting thorough gap assessments to evaluate current levels of compliance
- Modifying existing QMS to meet Brazil’s GMP requirements
- Performing on-site mock audits in preparation for ANVISA inspections
- Providing on-site support during ANVISA inspections
Expertise in QMS Requirements
Emergo by UL has experience with a range of quality management system requirements, including:
- FDA QSR (21 CFR part 820)
- ISO 13485
- Japan Ordinance 169
The company can help companies comply with QMS requirements in Brazil and worldwide.
Additional Resources for Brazil
For more information on compliance audit checklists in Brazil, readers may visit the ANVISA website or consult with a regulatory expert at Emergo by UL. Within the UL family of companies, there are also certification, notified body, and consultancy services available to support medical device manufacturers.