Registration in Canada
We assist manufacturers in the registration process on the Canadian market
For Class II, III, or IV medical devices, a manufacturer intending to sell their medical devices in Canada must obtain a Medical Device License (MDAL) from the competent authority, Health Canada, in accordance with the classification set out by Canadian regulations.
As a prerequisite for obtaining an MDAL product license, manufacturers of Class II–IV devices must have a quality management system certified in compliance with ISO 13485 requirements under the Medical Device Single Audit Program (MDSAP), which includes the QMS requirements of the Canadian Medical Device Regulations (SOR/98-282).
Maytal can assist medical device manufacturers with:
Product classification according to CMDR (SOR/98-282) requirements
Support in obtaining MDAL licenses for Class II, III, and IV products, including liaising with Health Canada
Support in obtaining MDEL licenses where applicable (e.g., Class I devices)
Analysis of product labelling requirements
Alignment of the quality system with MDSAP requirements
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