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Canada - Regulations Amending the Medical Devices Regulations (Establishment Licenses)
This proposal outlines Phase II of Health Canada's efforts to modernize the Medical Device Establishment Licensing (MDEL) framework, addressing emerging health and safety risks while maintaining effective regulatory oversight.
The proposed amendments include:
- Removing the requirement for importers holding an MDEL to import only from foreign distributors with an MDEL.
- Requiring MDEL applicants to provide detailed supplier information during the application process and ensure this information is updated annually at the license review.
- Clarifying requirements for manufacturers, importers, and distributors to establish, implement, and maintain documented procedures related to safety management activities.
Source Link:
G/TBT/N/CAN/758