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Health Canada announces REP Expansion Canada

Health Canada announces REP Expansion

The Health Products and Food Branch of Health Canada, the Canadian regulating authority in the sphere of medical devices, issued a notice on the expansion of the medical device Regulatory Enrolment Process (REP) pilot program. Regulatory Enrolment Process: Regulatory...

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FDA Template for Home Collection Kits FDA

FDA Template for Home Collection Kits

The Food and Drug Administration (FDA), the United States’ authority for medical devices regulation, issued home specimen collection molecular diagnostic template in order to provide medical device manufacturers with the recommendations related to the content of...

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Health Canada Guidance for Private Label Medical Devices

The Health Canada, the Canadian authority responsible for medical devices regulation, issued guidance dedicated to the application for a new license of making amendments to existing one for private label medical device. The document is intended to assist all parties...

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