Three tiers of change control under RDC 751/2022

1. Key takeaways

Brazil divides changes to registration or notification information into 3 tiers: changes requiring approval, changes with immediate implementation, and non-reportable changes (Art. 16 of RDC 751/2022). Misclassifying is the highest-frequency compliance failure — classifying too low constitutes an unreported change, while classifying too high forces a change that could take effect immediately through an extra procedural round. GRZAN gives one special alert: the former deadline of uploading documents within 30 days after submission for immediately-implemented changes has been deleted by RDC No. 777/2023, and internal SOPs should no longer carry that 30-day clock. A determination table built on the superseded clause produces wrong internal milestones even when the underlying change handling is otherwise sound.

2. Legal basis

• Classification, Notification and Registration of Medical Devices, and Labeling and Instructions for Use Requirements — RDC No. 751/2022, decided on September 15, 2022, effective March 1, 2023 (Art. 67), Art. 16 (including §§3 and 4), Arts. 21, 22, 24, 25 and 26
• Issuance and Renewal of Good Manufacturing Practice Certificates — RDC No. 687/2022, effective June 1, 2022 (Art. 17), Art. 3
• Essential Safety and Performance Requirements — RDC No. 848/2024, published in the DOU on March 8, 2024, Art. 1 §3, Art. 85
• Classification, Notification and Registration of Medical Devices (Amendment) — RDC No. 777/2023, decided and effective March 1, 2023, amending Art. 2 §3, Art. 16, Art. 22 and Art. 39 of RDC 751/2022 (article-by-article amendment content compiled from industry and law-firm sources, a practical estimate, subject to ANVISA publication)

3. Expert insights

The three-way split of Art. 16 is the backbone of Brazilian change management. Art. 21: changes requiring approval take effect only after the final decision is published in the DOU. Art. 22: immediately-implemented changes may be implemented from completion of submission, without waiting for ANVISA’s documentary review; the former deadline of publishing (uploading) documents within 30 days after submission has been deleted by RDC No. 777/2023 (a practical estimate, subject to ANVISA publication). Art. 16 §4 adds an easily overlooked rule — changes to Class I and Class II devices always follow immediate implementation unless they are non-reportable.

Another variable to track in parallel is that RDC 751/2022 itself has been amended. RDC No. 777/2023 (decided and effective March 1, 2023) amended RDC 751/2022: Art. 2 §3 moved to the wording custom-made devices (sob medida); Art. 16 corrected the reference to IN 74/2020; Art. 22 deleted the deadline of uploading documents within 30 days after immediately-implemented changes; Art. 39 narrowed the situations that can lead to suspension of production, import, distribution, sale and use; and the former Art. 40 was revoked. GRZAN’s judgment: what change management fears most is running internal determinations on superseded clauses — setting internal nodes against the deleted 30-day deadline builds the SOP wrong. A separate distinction is the instructions for use (IFU) upload deadline: it is governed by Art. 33 §§5 and 6, with the two starting points of within 30 days after DOU publication and within 180 days after implementation of the change, which is not the same matter as Art. 22 and must not be conflated. The determination table must be anchored to the current version, with the version number written into the ledger. (The existence of RDC 777/2023 is confirmed by Brazil’s WTO TBT notification; the article-by-article amendment content is from secondary sources, a practical estimate, subject to ANVISA publication.)

GRZAN’s judgment is that the non-reportable tier exists for the holder’s quality system to govern itself: Art. 16 §3 states expressly that such changes are controlled by the holder’s quality system and must be merged into subsequent applications. This means non-reportable does not mean unrecorded — quite the opposite, it demands internal determination records that can be produced at inspection. Many companies read this tier as no action needed, which is the most dangerous interpretation available.

The second pitfall is manufacturing-site changes. Art. 24 binds the approval of adding or changing manufacturing units, and of adding products or models to Class III/IV families, systems or kits, to publication of the CBPF in the DOU; and Art. 3 of RDC 687/2022 confines the CBPF to the production units of Class III/IV devices. Stacking the two yields the conclusion: for Class III/IV, a site change needs the CBPF published before the change can be approved; Class I/II are not bound by this constraint.

Third judgment: sell-off is the most practical part of change management. Art. 25 permits parallel import and sale of old and new versions of finished products until the end of the product’s validity period or useful life; Art. 26 grants packaging, labeling and instructions for use a 120-day sell-off period counted from publication of the change. The provisos in both articles match — changes made to resolve product safety and performance problems do not qualify. GRZAN recommends treating 120 days as the default window for revision scheduling.

Fourth trade-off: under the ESPR view, a change must be looked at again for its effect on safety and performance. Art. 1 §3 of RDC 848/2024 places compliance verification in the three scenarios of GMP inspection, marketing authorization or notification procedures, and product sanitary inspection. Where a change affects ESPR conformity, the administrative filing alone is insufficient and the technical evidence must be updated in step.

Fifth judgment: change management is the main line of post-market compliance, not an administrative chore. Of the three verification scenarios above, GMP inspection and product sanitary inspection are both triggered post-market, and the change ledger is a mandatory item in both kinds of inspection. Building the ledger as an evidence package retrievable at any moment costs far less than reconstructing records afterward.

4. Practical recommendations

• Build a change—tier—basis—evidence determination table, recording the classification rationale and the reviewer for every change.
• Keep internal review records for non-reportable changes too, and schedule them to be merged into the next application update.
• For Class III/IV manufacturing-site changes, schedule the CBPF publication date first, then the change application.
• Back-plan revision production from the 120-day sell-off window; safety and performance changes get no buffer and switch over directly.
• Build the change ledger as an evidence package retrievable at any time, covering classification rationale, technical assessment and implementation dates.
• For changes touching the ESPR, update the technical evidence and risk management files in step.

5. Verification checklist

• □ Has every change been tiered with its classification basis recorded?
• □ Did changes requiring approval wait for DOU publication before implementation?
• □ Are immediately-implemented changes tracked for publication after submission, with internal SOPs no longer carrying the 30-day upload deadline deleted by RDC 777/2023?
• □ Are manufacturing-site changes conditioned on CBPF publication?
• □ Does the sell-off plan distinguish safety and performance changes?

Regulatory information verified as of October 29, 2026

GRZAN Regulatory Team

GRZAN maintains change control systems for Brazil — tier determination tables under RDC 751/2022 as amended by RDC 777/2023, sell-off scheduling, CBPF-linked site changes and ESPR-aligned technical evidence updates across the product lifecycle. For change management support in Brazil, contact GRZAN at info@grzanglobal.com.