As of June 3, 2024, it will be possible to place one’s high-risk Medical Devices in Brazil, relying on authorisations from other selected countries worldwide. This path significantly accelerates registration procedures and can only be welcomed with enthusiasm by the industry.
The important news has been formalised by ANVISA, the Brazilian Regulatory Agency, with Regulatory Instruction 290/2024 of April 8, 2024, which defines the optimised procedures for the analysis and approval of applications for registration of Medical Devices, the criteria to be used in the evaluations conducted by the Equivalent Foreign Regulatory Authorities (known as AREE).
The measure is an important step in the Regulatory Reliance Programme, encouraged by the World Health Organisation (WHO), which defines Regulatory Reliance as such: ‘an act by which the national regulatory authority of a jurisdiction, in reaching its own decision, takes into account the assessment made by another authority or trusted institution or additional relevant information. The authority adopting this approach remains independent, responsible for its decisions and accountable for those decisions, even if it relies on decisions and information from other authorities.
Equivalent Foreign Regulatory Authorities (AREE)
The Equivalent Foreign Regulatory Authorities (AREE) represent four of the five former founding countries of the Global Harmonisation Task Force (GHTF). The GHTF is a voluntary group of representatives of national medical device regulators and industry established to encourage regulatory harmonisation and convergence between different countries worldwide to foster the deployment of safe and effective devices.
The authorised AREE include:
- TGA – Australian Register of Therapeutic Goods (ARTG)
- Health Canada – Medical Device Licence
- US FDA – 510(k) Clearance, Premarket Approval (PMA) or 513(f)(2) ‘De Novo’
- Japanese MHLW – Pre-market approval (Shonin)
How does the optimised entry of Medical Devices in Brazil work?
First, it should be noted that 290/2024 only applies to class III and IV Medical Devices and IVDs that normally have to go through the registration procedure.
Such devices, if they have already been authorised by one of the four AREE, can be released in Brazil much more quickly. A main AREE must be identified and, if several authorisations have been obtained, additional AREE can be reported.
Documents must be presented to prove that the products intended for the Brazilian market have the same production characteristics, indications and intended use approved by the recognised regulatory authority.
To apply for a marketing authorisation, it is necessary to submit:
- A declaration signed by the technical director and legal officer;
- A proof of authorisation received from the identified Equivalent Foreign Regulatory Authority;
- The instructions for use (IFU).
The Reliance route accelerates entry to the Brazilian market but does not exclude certain steps, such as the submission of the technical dossier at the application stage and compliance with other specific registration requirements, such as the submission of INCQS, B-GMP, INMETRO or ANTEL certificates.
It is estimated that the Reliance pathway would reduce ANVISA review times by at least 30%, with a substantial decrease in waiting times for registrations, allowing the population faster access to Medical Devices important for public health.
>> Thema can accompany you on the Brazilian market with strategic-regulatory consulting services assisting you in the registration of your Medical Devices in Brazil either through the Reliance route or in case you have never registered your Medical Devices in Australia, Canada, U.S.A. or Japan.
