Wasabibarako,
The "mists" imo are about making claims about safety and performance otherwise what is the point. Remember FDA and Zolpimist.
Well a key change to EU and TGA medical device regulation is:
More rigorous clinical evidence for class III and implantablemedical devices - Manufacturers will need to conduct clinical investigations incase they do not have sufficient clinical evidence to support the claims doneon both safety and performance of a dedicated device.
Wasabibarako,The "mists" imo are about making claims about...
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