Dear All
Health Canada has published a guidance document entitled “Guidance for Industry: Preparation of a Premarket Review Document in Electronic Format for a Class IV Medical Device Licence Application”.
The guidance defines the electronic file requirements and provides guidance on the format, structure, and content of electronic information to be included with a Class IV device license application. A copy of the guidance document can be downloaded from here.
Regards
S. Subramaniam
Health Canada has published a guidance document entitled “Guidance for Industry: Preparation of a Premarket Review Document in Electronic Format for a Class IV Medical Device Licence Application”.
The guidance defines the electronic file requirements and provides guidance on the format, structure, and content of electronic information to be included with a Class IV device license application. A copy of the guidance document can be downloaded from here.
Regards
S. Subramaniam