Brazil EFRA List: The Four Recognized Foreign Regulatory Authorities

1. Key takeaways

IN 290/2024, effective June 3, 2024, recognizes as equivalent foreign regulatory authorities (AREE/EFRA) exactly 4 bodies under its Article 6: Australia’s TGA (evidence form: ARTG entry), Canada’s Health Canada (evidence form: Medical Device Licence), the US FDA (evidence forms: 510(k), PMA, De Novo), and Japan’s MHLW. The European Union is not on the list, and China’s NMPA is likewise not on the list — neither a CE certificate nor an NMPA registration certificate can be exchanged directly for the optimized review pathway. GRZAN’s judgment: in nine out of ten failed matches, the reason is not that a country is missing from the list, but that the certificate in hand does not correspond to the evidence form the list requires; and the Chinese companies that treat CE or NMPA certificates as their strongest assets are precisely the ones most likely to hit the wall of this 4-authority list.

2. Legal basis

• Optimized review procedure (regulatory reliance) — IN nº 290/2024, issued April 4, 2024, effective June 3, 2024: Article 6
• Optimized review procedure (regulatory reliance) — IN nº 290/2024, issued April 4, 2024, effective June 3, 2024: Article 2, Article 3, Article 4, Article 5(II), Article 8
• General criteria for the acceptability of review outcomes of equivalent foreign regulatory authorities — RDC nº 741/2022, resolution of August 10, 2022: Article 1, Article 2, Articles 3 through 5
• Requirements for the classification, notification and registration of medical devices and for labeling and instructions for use — RDC nº 751/2022, resolution of September 15, 2022: Article 5, Article 7

3. Expert insights

Why does Article 6 pair each authority with an evidence form instead of simply listing countries? GRZAN’s reading: a single regulator may issue several different kinds of approval, and regulatory reliance can only be built on the class of evidence whose review depth is sufficient and which carries the regulator’s own endorsement. The US FDA illustrates the point: Article 6 names 510(k), PMA, and De Novo as the evidence forms precisely to box in what may be relied upon.

Following that logic, the point most worth spelling out becomes clear: the EU is not on the list, and neither is China’s NMPA. The EU case is structural — conformity assessment is performed by Notified Bodies, and the regulator itself never issues an approval, so there is no corresponding approval evidence within Brazil’s regulatory-reliance framework. China’s NMPA is a different matter: it is itself the regulator and issues the certificates directly, so the evidence form is not what is missing — but Article 6 of IN 290/2024 simply does not include it. The distinction GRZAN wants to underline is exactly this: it is not an incomplete-file problem; it is a not-on-the-list problem, and no amount of supplementary documentation fixes it. For companies whose only foreign assets are CE or NMPA certificates, the optimized review route is temporarily closed, and scheduling must proceed on regular review. Explaining this distinction clearly is worth more than telling clients to wait a few more months.

The second common blind spot is substantial equivalence. Article 5(II) defines the substantially equivalent device, and Article 8 further requires the Brazilian device and the foreign-approved device to match in qualitative and quantitative composition, physicochemical, mechanical, electrical, and biological characteristics, indications and intended use, manufacturer, manufacturing process, and safety and performance study results — 6 comparison element categories in total. GRZAN’s judgment: even when the evidence form matches, if the Brazilian version has drifted from the foreign version in materials, process, or intended use, the foundation of reliance still fails.

The third judgment concerns order. Article 3 requires prior AREE approval, and Article 2 confines the pathway to first-time registration applications for Class III (high-risk) and Class IV (maximum-risk) devices, IVDs included. GRZAN recommends a self-check in 5 steps — classification, then first application, then simplified procedure, then evidence form, then substantial equivalence — and there is no need to proceed once a step fails.

The last judgment: ANVISA retains final decision-making authority and may return the application to regular review. Optimized review is an opportunity, not a right.

4. Practical recommendations

First, build 1 evidence-form comparison table. Map every foreign certificate you hold — issuing authority, number, approval route — against the 4 authorities and their evidence forms listed in Article 6, and flag every gap individually.

Second, if you hold only CE or NMPA certificates, go straight to the regular pathway. The GRZAN regulatory team recommends not spending time waiting for NMPA to be added to the list — the list is a legislative matter, not something supplementary paperwork can move. Put the resources into the CBPF and the technical documentation instead; those are the decisive variables in regular review.

Third, screen for simplified procedures first. Holders of US approvals should confirm immediately whether Article 4’s exclusion is triggered, because this single step sets the whole schedule.

Fourth, fix the equivalence statement. Issue a substantially-equivalent comparison statement across the 6 element categories and file it with the dossier, so the review stage does not have to request explanations.

Fifth, keep a regular-pathway fallback schedule. Post-approval validity remains 10 years from the DOU publication date regardless of the review method, and companies should not delay CBPF preparation while waiting for optimization.

5. Verification checklist

• □ AREE/EFRA approval has been obtained from one of the 4 authorities enumerated in Article 6 of IN 290/2024
• □ The evidence form aligns item by item with the enumerated forms (TGA-ARTG / HC-MDL / FDA 510(k), PMA, De Novo / MHLW)
• □ It is confirmed that EU CE and China NMPA are both outside the recognized list, and scheduling follows regular review where only those are held
• □ The approval is not a simplified-procedure approval (Article 4 exclusion)
• □ The application is a first-time Brazilian registration for a Class III or IV device
• □ The substantially-equivalent comparison across the 6 element categories is complete per Article 5(II) and Article 8
• □ The Portuguese-text comparison record of Article 6 of IN 290/2024 has been filed in the project archive

Regulatory information verified as of October 29, 2026

GRZAN Regulatory Affairs Team

GRZAN supports manufacturers in the Brazilian market with ANVISA registration pathway and classification strategy services, including EFRA eligibility mapping against the Article 6 list of IN 290/2024, evidence-form gap analysis, and regular-pathway planning for portfolios relying on CE or NMPA certificates. To find out which route your certificates actually unlock, contact the GRZAN regulatory team at info@grzanglobal.com.