Update on New Medical Device License Legislation
As you may know, new legislation will come into effect on January 1, 2019, requiring all medical devices with a Class II designation or higher to be certified through the Medical Device Single Audit Program (MDSAP). Manufacturers will be required to comply with this new regulation in order to maintain and/or obtain a medical device license (MDL) for any Class II, III, and IV medical device sold in Canada after January 1, 2019.
HealthPRO continues to work closely with its suppliers to ensure they are working to meet this new legislation and will be compliant by year end. Since any suppliers who are not compliant will not be able to sell their products after the legislation date, it is imperative that contracted suppliers are on track with their obligations to this new legislation.
Members are encouraged to ensure that suppliers of their non-HealthPRO-contracted items are also aware of and compliant with this new legislation. Members are encouraged to ensure that suppliers of their non-HealthPRO-contracted items are also aware of and compliant with this new legislation. HealthPRO has also developed a template that can be helpful to members in undertaking this process.
If you have any questions, please contact:
Director, Clinical Services
905-568-3478 ext. 401
The MDSAP process is a single audit program introduced into Canada that requires medical device manufacturers to conduct an audit against the requirements for medical device regulation of Health Canada. The transition to the MDSAP process must be complete by manufacturers by January 1st, 2019, as mandated by Health Canada. A valid MDSAP certificate with a form F202 must be submitted by December 31, 2018 to the Medical Devices Bureau. This applies specifically to medical devices with a Class II designation or higher.