Medical device registration in Canada
Canada has one of the best regulatory systems in the world for medical devices, with some of the most stringent requirements.
Health Canada reviews medical devices to assess their safety, effectiveness and quality before being authorized for sale in Canada.
Health Canada reviews medical devices to assess their safety, effectiveness and quality before being authorized for sale in Canada.
How to register for your medical devicein Canada
Classification:I, II, III, IV Quality Management System: All manufacturers of Class II, III and IV devices must switch to the Medical Device Single Audit Program (MDSAP) to obtain the ISO 13485 certificate.
The class I medical device manufacturer who intends to sell their medical devices directly to the user in Canada must obtain an MDEL. The manufacturer who intends to sell to the importer on site must obtain it if he is not already in possession of it.
Class II, III and IV medical device manufacturers who intend to place their devices on the Canadian market must have an MDL following the issuance of the ISO 13485 certificate.
The class I medical device manufacturer who intends to sell their medical devices directly to the user in Canada must obtain an MDEL. The manufacturer who intends to sell to the importer on site must obtain it if he is not already in possession of it.
Titansmedical can help you with medical device or IVD registration, act as your Authorized representative and support you with distributor identification and importation.
