Update for the Guidance "How to Complete the Application for a New Medical Device License"

Health Canada prepared an update to the Existing Guidance for the Application for new medical devices.

This guidance helps manufacturers to prepare the Device License Application and the recant documentation.

The update relates mainly to class II License Application and includes the text relevant to high-level disinfectants and sterilants.

 

The Effective date is 2018-03-16

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