MDAL
For class II, III or IV medical devices, a manufacturer who intends to sell 
their medical devices in Canada will have to obtain a MDAL product license from the competent authority Health Canada (according to the Canadian regulatory classification). As a pre-requisite for obtaining the MDAL product license, manufacturers of class II to IV products must have a quality system certified in accordance with the ISO 13485 quality system requirements in the Medical Device Single Audit Program (MDSAP), which includes the QMS requirements of the Canadian Medical Device Regulation (Sor98/282). Maytal can assist the manufacturers of Medical Devices in:
their medical devices in Canada will have to obtain a MDAL product license from the competent authority Health Canada (according to the Canadian regulatory classification). As a pre-requisite for obtaining the MDAL product license, manufacturers of class II to IV products must have a quality system certified in accordance with the ISO 13485 quality system requirements in the Medical Device Single Audit Program (MDSAP), which includes the QMS requirements of the Canadian Medical Device Regulation (Sor98/282). Maytal can assist the manufacturers of Medical Devices in:- Classification of products based on CMDR requirements (SOR98 / 282)
- In obtaining the MDAL for products class II, III and IV, including the report by the Health Canada Authority
- Analysis of the labeling requirements for the product
- Adaptation of the QMS to the MDSAP requirements
