ANVISA BGMP Certification Timeline for Brazil

1. Document Review Phase: Approximately 4 months
2. On-site Audit Phase: Estimated 6 months
3. Certification Evaluation Phase: Commences only after audit approval, takes roughly 2 months

FAQ

Q: What are the special mandatory requirements under BGMP?

1. Purchasing & Supplier Controls Verify that all consultants engaged for medical device design, procurement, manufacturing, packaging, labeling, storage, installation or after-sales services hold valid professional qualifications. Per ANVISA RDC 16/2013 Clause 2.3.3, formal written contracts must be signed with all consulting service providers. ANVISA mandates consulting services to be fully governed by the manufacturer’s purchasing control procedure, including standardized supplier assessment criteria and formal evaluation workflows.
2. Document Control Maintain complete change records containing full change descriptions, unique document identifiers, authorized signatories, approval dates and effective implementation dates (RDC ANVISA 16/2013 Clause 3.1.5). Companies shall maintain a master register of all current, approved documents. Electronic records and secure data backup systems must be fully established (RDC ANVISA 16/2013 Clause 3.1.6).
3. Nonconforming Product Management Formal evaluation processes for nonconforming products must be documented, including formal investigations and notifications to accountable personnel or departments. All assessments and follow-up investigations shall be fully recorded on file (RDC ANVISA 16/2013 Clause 6.5.1). Manufacturers must implement documented procedures for product recalls and other post-market field safety corrective actions for distributed products (RDC ANVISA 16/2013 Clause 7.1.1.8).
4. Corrective and Preventive Actions (CAPA) Maintain records identifying all quality nonconformities. Where applicable, formal CAPA documentation must be submitted to regulatory authorities for official notification and ongoing surveillance (RDC ANVISA 16/2013 Clause 7.1.1.7).

Q: When shall renewal applications be submitted prior to BGMP expiry?