Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Optimized analysis for class III and IV devices approved abroad

Brazil · Brazilian Health Regulatory Agency · Medical devices

Reliance route, abridged reviewFaster routeHigh confidenceLast verified October 3, 2026

Review target

Not published

Legal time limit

Not published

Steps

3 requirements

Application fee

What is the Optimized analysis for class III and IV devices approved abroad in Brazil?

Registration petitions for class III and IV devices and IVDs already authorized in Australia, Canada, the United States or Japan can be reviewed using the foreign authorization. The petition keeps its place in the queue, and Anvisa can still choose the ordinary review. Class III or IV devices or IVDs authorized by one of the listed authorities for an essentially identical device, not through an abbreviated foreign route similar to this one.

What are the steps of the Optimized analysis for class III and IV devices approved abroad?

1. File the ordinary registration; 2. Reliance addendum; 3. Optimized review; 4. Decision.

Does the Optimized analysis for class III and IV devices approved abroad rely on other regulators?

Yes. It relies on approvals from Australia, Canada, Japan, United States (shorter review, shorter review, shorter review, shorter review).

Outcome: Registration decided by Anvisa; same rules and penalties as ordinary registration. Valid for 10 years.

Legal basis: Anvisa RDC 741/2022; Anvisa IN 290/2024; Anvisa RDC 751/2022; Anvisa RDC 830/2023

How the pathway works

Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).

ApplicantRegulatorCertification bodyCommitteeClock stopped

Timeline with clock stops

Official step durations

Steps

In order, with the official target for each step

1. File the ordinary registrationAll documents required for ordinary registration are filed.
2. Reliance addendumA secondary petition with a signed eligibility declaration, the legalized foreign authorization and the instructions for use used in that jurisdiction. Without it, the ordinary review applies.
3. Optimized reviewAnvisa reviews using the foreign authorization. It may switch to the ordinary review and must explain why.
4. DecisionAnvisa decides independently of the foreign authority.

Requirements

What the applicant must provide or meet

Reference approval

Authorized by a listed authorityAuthorized by at least one listed authority for an essentially identical device, with the same intended use and manufacturer.

Eligibility

Official time targets

Targets, not actual review times

No time targets published.

Fees

Official amounts in the local currency

Fee	Amount
No fees published.

Reliance on other regulators

AustraliaShorter reviewTGA, entry in the Australian Register of Therapeutic Goods, for an essentially identical device.
CanadaShorter reviewHealth Canada medical device licence, for an essentially identical device.
JapanShorter reviewJapan MHLW pre-market approval (Shonin), for an essentially identical device.
United StatesShorter reviewUS FDA 510(k) clearance, premarket approval or De Novo, for an essentially identical device.

Other routes in Brazil: Good manufacturing practice certification (CBPF), Notification of a class I or II medical device, Registration of a class III or IV medical device, Notification of a class I or II in vitro diagnostic device, Registration of a class III or IV in vitro diagnostic device, Software as a medical device (notification or registration). See all routes on the Brazil page or explore them in the Regulatory section.

Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (14 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.