An IVF company in Brazil called Overture Life has just had an automated cryogenic freezing device for IVF cleared for use in Brazil by the Brazilian National Health Surveillance Agency (ANVISA). The device has been cleared for commercial sale and use (as per below screenshot).
As we know MEM has just started commercial discussions with a company called Androscience in brazil to introduce the Felix System into the Brazilian market, as per following link (Link to post about Brazil Androscience deal:
https://hotcopper.com.au/posts/78693773/single ).
The interesting thing about this is that apparently, the Overture Life device was classified as a Class 1 medical device for the regulatory clearance process.....and here is the really interesting part...............registration for commercial sales of class 1 and class 2 devices in Brazil are described below, alongside the average timeframe to achieve registration (apparently it only takes 1 to 3 months for the process):
Key Differences and Timeframe for Registration :
- Class I devices are non-invasive and pose minimal risk, requiring a simpler and faster approval process.
- Class II devices may have some level of invasiveness or require additional documentation for safety compliance, making the approval process slightly longer than Class I devices.
Both classifications allow for a notification-based registration, avoiding the lengthy full registration process required for higher-risk devices like Class III and IV.
If my research is accurate, then MEM device could potentially be classified as a Class 1 or Class 2 device and therefore could potentially receive clearance for sale in as little as 3 months through a notification process provided by the Brazilian regulator.
Felix sales and a commercial deal for Felix sales in Brazil could be much closer than we think.
(20min delay)