 MDAL (Medical Device Application License) and MDEL (Medical Device Establishment License) are the product license and plant license required for access to the Canadian market for certain classes of Medical Devices. |
Market access: Canada
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
MDEL
A foreign manufacturer must obtain a medical device 
establishment license (MDEL) if he intends to sell medical devices directly in Canada which, according to the classification envisaged by the Canadian Medical Device Regulation (Sor98/282), fall into class I.
Maytal can assist the manufacturers of Class I Medical Devices in obtaining the MDEL license.
establishment license (MDEL) if he intends to sell medical devices directly in Canada which, according to the classification envisaged by the Canadian Medical Device Regulation (Sor98/282), fall into class I.Maytal can assist the manufacturers of Class I Medical Devices in obtaining the MDEL license.
