Health Canada Eases MDSAP Deadline
Health Canada is sticking to its compliance deadline of Jan. 1, 2019, for devicemakers selling products in Canada to transition to the Medical Device Single Audit Program, but it is making adjustments to help manufacturers comply.
The regulator said it would not take enforcement action if manufacturers have undergone a MDSAP audit by Dec. 31, 2018. The modifications to the transition process were made due to industry comments around scheduling MDSAP audits and the requirement to have a MDSAP certificate by the Dec. 31 deadline.
The agency said it recognizes that some manufacturers are facing challenges in scheduling MDSAP audits in 2018, and may not be issued their MDSAP certificate by Dec. 31, 2018 as there is often a delay between the timing of the audit and the issuance of the certificate.