In yesterday’s post we talked about the publication of IN 290/2024, which talks about the procedure for optimized analysis of petitions for registration of Medical Devices through the use of analyzes carried out by an Equivalent Foreign Regulatory Authority. Today we bring the highlights of this regulation for clarification:
ANVISA determined some rules for this optimized procedure, which are:
1- The following Regulatory Agencies and respective proof of registration or authorization will be accepted for the purposes of adopting the optimized analysis procedure:
– Australia: Australia Therapeutic Goods Administration (TGA) – Australian Register of Therapeutic Goods (ARTG);
– Canada: Health Canada (HC) – Medical Device License;
– United States of America (USA): US Food and Drug Administration (US FDA) – 510(k) Clearance, Premarket Approval (PMA) or 513(f)(2) “De Novo”;
– Japan: Japan Ministry of Health, Labor and Welfare (MHLW) – Pre-market approval (Shonin).
2- The petition must be posted in the same way as before, containing all documents.
3- The supporting documentation for the optimized analysis must be requested as an amendment, that is, a second petition. After verifying this second petition, ANVISA will define whether the optimized analysis will be accepted or whether the ordinary analysis will be followed. The registration proof document must make reference to the essentially identical medical device intended to be registered in Brazil and include information relating to the indication(s) of use/intended use and manufacturer(s),
4- The IFU/user manual of the medical device to be presented in Brazil must be the same as that adopted and in force in the registered country
5- This optimized analysis does not speed up the analysis queue. The process will follow the normal queue time.
It is a great advance to have the possibility of simplifying the analysis process. The hope is that the petition queue will move 30% faster.
Click here to access the translated Normative Instruction
#regulatoryaffairs#medicaldevices#imdrf#anvisa#fda#TGA#healthcanada#shonin
