ANVISA Brazil Medical Device Regulations
Manufacturers who wish to sell and distribute their medical device or IVD in Brazil must first comply with ANVISA medical device regulations.
Key medical device and IVD regulations in Brazil
The Agencia Nacional de Vigilância Sanitaria, known as ANVISA, is the regulatory agency for medical devices in Brazil. ANVISA enforces compliance with regulations that govern the distribution of goods such as medication, medical tools, food, and beauty products. Manufacturers who wish to sell and distribute their medical device or IVD in Brazil must first comply with pre-market regulatory requirements to obtain market authorization from ANVISA.
After more than two decades, Brazil implemented new regulations for medical devices and IVDs in 2023 and 2024, respectively. The new regulations demonstrate ANVISA’s goal to streamline its regulatory processes through harmonization with established industry frameworks, particularly the European Union (EU) and International Medical Device Regulators Forum (IMDRF).
There are two key medical device regulations in Brazil:
- Resolution (RDC) 751/2022 is the regulation that applies to medical devices in Brazil. It went into effect March 1, 2023, replacing RDC 185/2001.
- Resolution (RDC) 830/2023 is the regulation that applies to IVDs in Brazil. It went into effect June 1, 2024.
ANVISA also updated and expanded its essential safety and performance requirements with Resolution (RDC) 848/2024, which now includes IVDs in its scope.
ANVISA Brazil medical device regulatory process
Medical devices and IVDs are classified according to their risk profile. Though the classification rules for medical devices are different than for IVDs, medical devices and IVDs are classified into four tiers of increasing risk: Class I, II, III, IV.
Classification determines a product’s regulatory pathway. Both Class I and Class II products must follow the Notification pathway, in which devices are automatically approved for sale by ANVISA.
Class III and Class IV devices must follow the Registration pathway, which includes a regulatory review and approval by ANVISA. Because Class III and Class IV products have higher risk levels, the audit requirements are rigorous, resulting in a longer process. You must also implement a quality management system (QMS) that complies with Brazilian Good Manufacturing Practices (BGMP) and obtain BGMP certification.
All manufacturers without legal entities in Brazil must designate a Brazil Registration Holder (BRH). Your BRH is your liaison to ANVISA for all regulatory activities and acts as your authorized representative. They are also named on your ANVISA registration.
Helpful resources for ANVISA medical device registration
As you begin planning to market your device in Brazil, here are some resources that will be useful along the way:
- ANVISA: Brazil’s medical device and IVD regulatory authority.
- Resolution (RDC) 751/2022 (link in Portuguese): Brazil’s primary medical device regulation.
- Resolution (RDC) 830/2023 (link in Portuguese): Brazil’s primary IVD regulation.
- Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nlVD MA ToC): IMDRF guidance document on medical device technical dossier submission structure.
- MDCG 2021-24 Guidance on classification of medical devices: European guidance on medical device classification under the EU MDR, which aligns closely with Brazil’s new medical device classification rules.
Frequently
Asked Questions
How much does it cost to register a medical device in Brazil?
Depending on classification, manufacturers can expect an estimated total cost between $5,000 and $25,000 per registration. This normally includes Brazil Registration Holder, Registration fees, and Government fees. It does not include testing costs.
Is it possible to expedite my ANVISA device registration?
Yes. Several regulatory pathways exist that can shorten ANVISA review times for higher risk devices. Class III and IV devices with certifications from an acknowledged Equivalent Foreign Regulatory Authorities (AREE) (i.e., Australia, Canada, USA, or Japan) can undergo a streamlined registration process with the IN 290:2023 analysis method if they belong to the IMDRF. The improved route enables a 30% faster review time, as certain documents will be skipped because of AREE validation. ANVISA also participates in the Medical Device Single Audit Program (MDSAP), which allows manufacturers to obtain QMS certification in participant markets with a single audit. Leveraging an MDSAP certificate can significantly reduce ANVISA review time.
Which medical devices require home country approval for ANVISA Brazil registration?
Imported Class III and IV medical devices must present proof of registration, free trade certificate, or an equivalent document as evidence of regulatory authorization in their country of origin. Class I and II devices are exempt from home country approval requirements.
