Canada Has Completed Its Transition to MDSAP
April 12th, 2019 // 8:00 pm @ jmpickett
Most of the medical device companies in the Canadian market were able to meet the deadline of Jan. 1 2019 to complete a transition to the Medical Device Single Audit Program or MDSAP. According to Health Canada’s Medical Devices Bureau, the organization was flooded early this year with the transition packages from many companies.
The large stack of transition packages took priority over determining the final statistics on how many companies were able to complete the transition to MDSAP. This transition in the Canadian market was thought to be more difficult compared to the other markets in the consortium for MDSAP. The MDSAP in Health Canada was different from other regions in that it is the one model designed to base its determinations on licenses in Class II, III and IV on certificates that are MDSAP valid. This makes the MDSAP program required to sell these medical devices in country.
Concerns about the MDSAP framework being mandatory meant that some smaller medical device companies delayed their entry into the market in Canada. Some planned to exit it. Health Canada reported late last year that some smaller medical device manufacturers did not want to conform to MDSAP requirements and decided to cancel their licenses in the country. However, MEDEC, the association that represents medical technology companies in Canada, said that making MDSAP a requirement in Canada did not generally deter most of its members from exiting the market.
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MDSAP is the backbone of the International Medical Device Regulators Forum. Inconsistencies in MDSAP model designs, which include the implementation framework, raised concerns among many industry associations. Health Canada worked hard to adopt changes to the MDSAP model that were focused on facilitating the transition, especially for smaller companies.
