Notificação vs Registro: Two Pathways for Medical Devices in Brazil under RDC No. 751/2022

1. Key takeaways

In Brazil, Class I/II and Class III/IV devices run on two parallel systems: the former through notification (notificação), the latter through registration (registro). The dividing line is written in Articles 6 and 7 of RDC n° 751/2022 (resolution of September 15, 2022, effective March 1, 2023). Registration-based marketing authorizations are valid for 10 years (Article 11); notification is handled as routine processing under Article 10, §6 with a 30-day processing window; and Article 28 further exempts notified products from revalidation.

2. Legal basis

• Classification, notification and registration of medical devices, and labeling and instruction-for-use requirements — RDC n° 751/2022, resolution of September 15, 2022, Articles 6, 7, 10 (§6, §7 and §9), 11, 14 (item V with §§2–3), 27, 28 and 56
• Basic law on sanitary oversight of health products — Lei n° 6.360/1976, enacted September 23, 1976, DOU September 24, 1976 (Seção 1, p. 12647), Article 12, §1 (original text set registration validity at 5 years with consecutive equal-period revalidations; as added by Lei n° 13.097/2015, ANVISA is authorized to set revalidation periods by its own regulation according to product nature and health risk, capped at 10 years)
• Company operating authorization and local sanitary licensing — Decreto n° 8.077/2013, published August 14, 2013, Article 8
• Application deadlines and lapse for registration revalidation — RDC n° 250/2004, resolution of October 20, 2004 (board meeting of October 18), DOU October 21, 2004 (anvisalegis official legislative library footer; volume, issue and page not obtained), Article 1 (with §§1 and 3; as rewritten by RDC n° 212/2018) and Article 4
• Grant and renewal of good manufacturing practice certificates — RDC n° 687/2022, effective June 1, 2022 per Article 17, Article 3
• Rules for in vitro diagnostic medical devices — RDC n° 830/2023, published in DOU No. 234 of December 11, 2023, Articles 12 and 71

3. Expert insights

GRZAN regards reading notification as mere registration paperwork as the most expensive misunderstanding in this area. The routine processing and 30-day window of Article 10, §6 describe administrative rhythm, not exemption from substantive duties: Article 10, §7 conditions the maintenance of both notifications and registrations on continued conformity with Brazilian good manufacturing practices, the essential safety and performance requirements (ESPR) and specific regulations; Article 56 requires notification holders to keep the technical dossier; and Article 60, §1 prohibits import and sale before DOU publication.

On validity periods, GRZAN most wants to correct a source-of-law error: the number is usually right, but the legal basis is wrong. Article 12, §1 of Lei n° 6.360/1976 and Article 8 of Decreto n° 8.077/2013 write 5 years; but the content added to the same §1 by Lei n° 13.097/2015 authorizes ANVISA to set revalidation periods by its own regulation according to product nature and health risk, with the cap at 10 years. The 10-year term that Article 11 of RDC n° 751/2022 gives to devices — running from the DOU publication date, renewable for consecutive equal periods — falls squarely within that statutory authorization; it is not self-empowerment by the regulation. The renewal window is likewise 6–12 months, and here the number is right but the basis is routinely miswritten: it does not come from Article 8, §2 of Decreto n° 8.077/2013, but from the horizontal regulation RDC n° 250/2004, Article 1 (as rewritten by RDC n° 212/2018) — the application must be filed no more than 12 months and no less than 6 months before expiry, counted backward from the expiry date (Article 4); failure to apply in time causes lapse (caducidade, Article 1, §1); expiry without a decision is deemed automatic renewal, but automatic renewal does not stop the review, and ANVISA may still refuse and cancel (Article 1, §3). That window was carried over to device revalidation by Article 27, §2 of RDC n° 751/2022. Applying the 5-year rule to devices produces a wrong renewal schedule.

The third difference lies in the approval precondition. For Class III/IV registration, Article 14, item V with §§2–3 lists the CBPF (Certificado de Boas Práticas de Fabricação) or its proof of submission among the mandatory documents, and approval is conditioned on the CBPF being published in the DOU. GRZAN treats this as the critical path in project scheduling: the sequence is not register first, then handle the factory — the CBPF must land first, or the registration has no exit.

The fourth point is a cognitive blind spot — notified products are said to have no validity period. Article 28 removes the revalidation duty, and many companies conclude that notifications can then be ignored. In reality the continuous compliance obligation of Article 10, §7 never stops.

Revalidation clauses, by contrast, are light. Article 27 requires only two documents for imported products: the manufacturer’s authorization statement (declaring authorization of the representative and of sales, and confirming conformity with RDC n° 665/2022) and a valid ANVISA BGMP certificate; Article 27, §3 permits starting the revalidation analysis with the CBPF proof of submission. GRZAN’s advice is to manage the validity of these two documents on a calendar rather than wait for a deficiency notice. Article 27, §1 also requires the authorization statement to confirm observance of RDC n° 665/2022 — effectively reconfirming BGMP responsibility at the revalidation point.

4. Practical recommendations

• Lock the pathway through risk classification first, then build the document list, so one template is not used for two different filings.
• Treat the CBPF as the critical path before registration for Class III/IV projects, reserving time for factory remediation.
• For Class III/IV imported products, prepare the letter of authorization (LOA) and certificate of free sale (CFS) in parallel.
• Schedule revalidation only under Article 11 of RDC n° 751/2022 — never on the 5-year rule — and keep a validity dashboard for the two Article 27 documents.
• Even though notifications are exempt from revalidation, maintain BGMP, ESPR and specific-regulation compliance evidence under Article 10, §7.
• Both pathways require the application form, IFU and label mock-ups in Portuguese (Article 10, §9); other documents may be in Portuguese, Spanish or English.
• Benchmark against Article 60, §1 before filing: no shipment, display or delivery for consumption before DOU publication.

5. Verification checklist

• □ The product class has been confirmed as Class I/II or III/IV and mapped to notificação or registro
• □ For Class III/IV projects, the CBPF or proof of submission has been confirmed on the document list
• □ The validity period has been unified at 10 years for devices, without the 5-year rule
• □ The renewal window has been counted backward from expiry under Article 1 of RDC n° 250/2004 (max 12 months, min 6 months), with the legal basis not miswritten as Decreto n° 8.077/2013
• □ After renewal, validity follows the last day of the preceding period (Article 2, §2 of RDC n° 250/2004), not the approval date
• □ The DOU placement of RDC n° 751/2022 has been checked as DOU No. 180 of September 21, 2022 (Seção 1, p. 172), with the resolution date of September 15, 2022 — two different days, cited separately
• □ A validity ledger exists for the two Article 27 documents
• □ Portuguese versions of the application form, IFU and label mock-ups are ready

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 pathway selection for notificação and registro, revalidation scheduling, CBPF coordination and post-market compliance. For assistance with Brazilian regulatory requirements, contact info@grzanglobal.com.