Brazil BGMP under RDC No. 665/2022: Scope, Ten Chapters and Ongoing Compliance Monitoring

1. Key takeaways

The current basis for Brazilian good manufacturing practices (BGMP) is RDC n° 665/2022, effective May 2, 2022 (Article 138), superseding RDC n° 16/2013 and IN n° 8/2013 (Article 137). Article 1, §2 expressly incorporates MERCOSUR GMC Res. 20/11 into the Brazilian system while repealing GMC Res. 04/95, 38/96, 65/96 and 131/96.

GRZAN’s judgment: the reach of BGMP is wider than most companies expect. It governs the full span from design through technical assistance, and a quality system trimmed down to the production floor will not survive the on-site inspection that follows.

2. Legal basis

• Brazilian good manufacturing practices — RDC n° 665/2022, published March 30, 2022 (DOU March 31, 2022), Article 1 with §2, Articles 103, 104, 105, 106, 137 and 138
• Classification, notification and registration of medical devices, and labeling and instruction-for-use requirements — RDC n° 751/2022, resolution of September 15, 2022, Article 10, §7, Article 14, item V, and Article 27, §1
• Grant and renewal of good manufacturing practice certificates — RDC n° 687/2022, Articles 3 and 17 (effective June 1, 2022)
• Health risk management and compliance monitoring for CBPF and CBPDA — RDC n° 982/2025, resolution of July 28, 2025, Articles 3 and 6

3. Expert insights

Article 1 writes 9 stages into a single code: design and development, purchasing, production, packaging, labeling, storage, transport, installation and technical assistance. GRZAN reads this as the product of reverse engineering the enforcement chain: when adverse events, field actions (Ação de Campo) or technical complaints occur, ANVISA needs to locate the responsible stage. A system covering only pre-release operations would leave the post-market service process as a regulatory blind spot. The fact that installation and technical assistance are listed separately is direct evidence that post-market service was deliberately pulled into the system — and these are precisely the stages foreign manufacturers most often omit. For importers the boundary matters even more: storage, transport and technical assistance are GMP duties in Brazil, not commercial terms that a contract can route around.

The ten-chapter structure runs: I general provisions, II quality system, III quality documents and records, IV design controls and the device master record (DMR), V process and production controls, VI handling, storage, distribution and traceability, VII corrective and preventive actions (CAPA), VIII installation and technical assistance, IX statistical techniques, X final provisions. Placing design controls in Chapter IV means that design activities outside Brazil also enter the audit’s field of view.

Four provisions deserve individual flags: Article 103 requires special processes to be validated per a prior agreement; Article 104 requires computerized systems and software that may affect quality to be validated; Article 105 requires periodic revalidation; and Article 106 requires change control to include a risk assessment. In GRZAN’s view, Article 106 writes risk-management thinking into the Brazilian GMP: an engineering change needs not only validation data but a risk conclusion. The prior agreement of Article 103 moves the approval point of the validation protocol before execution — a protocol patched together after the fact is not accepted in inspection.

The incorporation in Article 1, §2 also needs reading: MERCOSUR GMC Res. 20/11 was written directly into the Brazilian system while GMC Res. 04/95, 38/96, 65/96 and 131/96 were repealed [these GMC resolution numbers come from internal citations in the official text of RDC 665/2022; the resolutions themselves were not obtained from MERCOSUR official channels — verify against the current consolidated text of RDC 665/2022]. GRZAN’s reading is that Brazilian GMP duties acquire a regional coordination character: the MERCOSUR technical requirements and the domestic resolution are one and the same operative text, so companies need not reconcile two sets of demands — but neither will inspection accept the excuse of following another MERCOSUR text.

The first pitfall is treating an ISO 13485 certificate as the equivalent of BGMP. BGMP is Brazil’s own statutory system requirement, and compliance is expressed as the grant of a CBPF (Certificado de Boas Práticas de Fabricação); the two are not interchangeable. The second pitfall is language: inspection looks for executable evidence in Portuguese, and English-only system documents typically stretch the remediation cycle. The third comes from Article 6 of RDC n° 982/2025 — the grant and renewal of a CBPF are subject to ongoing compliance monitoring, and ANVISA may open investigations or cancel the certificate at any time. Obtaining the certificate is not the finish line but entry into a permanently observed state; annual internal audits and management reviews should leave an interface for this.

The fourth pitfall concerns the effective date in Article 138: the transition is long over, and teams still drafting system documents against RDC n° 16/2013 or IN n° 8/2013 are, in substance, preparing for the coming inspection on a superseded framework.

4. Practical recommendations

• Break the system build-out into the 9 stages of Article 1 one by one: design and development, purchasing, production, packaging, labeling, storage, transport, installation, technical assistance.
• Run a gap analysis against the ten-chapter structure, focusing on Chapter IV design controls and the device master record.
• Add risk assessment to the engineering change process per Article 106, and keep a revalidation ledger per Articles 103 and 105.
• Complete and archive validation of computerized systems and production software per Article 104.
• For Class III/IV production units, plan the CBPF in parallel and fold the ongoing compliance monitoring of RDC n° 982/2025 into the annual internal audit.
• For foreign plants, evaluate the Medical Device Single Audit Program (MDSAP) first: a CBPF granted through MDSAP is valid for up to 4 years (Article 8, §1 of RDC n° 497/2021, as amended by RDC n° 850/2024, effective April 1, 2024), at the price of staying continuously within the MDSAP system.

5. Verification checklist

• □ The effective date of May 2, 2022 under Article 138 of RDC n° 665/2022 has been confirmed
• □ The superseded instruments RDC n° 16/2013 and IN n° 8/2013 (Article 137) have been confirmed
• □ A coverage self-check against the 9 stages and ten-chapter structure has been completed
• □ Process validation, software validation and change risk records per Articles 103, 104 and 106 are in place
• □ The MDSAP route and the 4-year validity conditions have been assessed

Regulatory information verified as of October 29, 2026.

GRZAN Regulatory Team

GRZAN provides registration and compliance support for medical device and IVD manufacturers entering the Brazilian market, covering BGMP gap analysis, CBPF strategy and MDSAP evaluation, inspection readiness and post-market compliance. For assistance with Brazilian regulatory requirements, contact info@grzanglobal.com.