It's never easy being first. Living in the San Francisco Bay Area, I see constant reminders of why it isn't always good to be first. The darlings of Sand Hill one year can be a business school case study the next. Which is something that Canada is dealing with right now. Or at least will be in 2019.
January of 2019 is when Canada will fully adopt the Medical Device Single Audit Program (MDSAP) as the method of choice for inspecting medical device manufacturers marketing in their country. This, coupled with MDR / IVDR in the EU has put a huge strain on notified bodies and aged regulatory and quality professionals throughout the medical device industry. As companies scramble to bring their quality systems and products up to the new regulatory requirements, some have asked the question of "Is it worth it?". Or more to the point, "Is the market in Canada worth it?".
Recently, Health Canada has been taking steps to make this transition more palpable to device manufacturers. In April of this year they announced that they would not take enforcement action against manufacturers that have had an MDSAP inspection but don't yet have their certificate, an obvious acknowledgement that notified bodies and manufacturers are running a bit behind schedule. Then Health Canada announced in May that smaller device manufacturers (less than 100 people) making class II devices could see a reduction in audit times, which likely equates to a reduction in the regulatory burden as well. And there are rumors that the concessions aren't done.
So why Canada finding themselves standing in a game of musical chairs? Thus far, the other four members of the MDSAP program don't seem to be rushing in to join Canada in requiring MDSAP. It's somewhat surprising Canada is alone, given how every one of the member countries is struggling to keep pace with inspection schedules, especially the two largest members.
Brazil for example has only recently taken steps to clear their inspection backlog, but it's still a slog. You might yet see your 18 year old graduate college before that inspection occurs. They did recently decide to grant GMP licenses to manufacturers that submitted MDSAP certificates, but it's not clear what that means for premarket inspections. Australia has been dead quiet on the topic, with the last TGA update on their website occurring in Dec 2016. Japan has agreed to make ISO13485:2016 a requirement, but they are still vague on MDSAP. And with the US seemingly content with a pre-World War II isolationist strategy, there's not much hope of FDA joining the MDSAP party.
Which leaves Canada holding the bag, at least for now. Presumably other countries - particularly Brazil- will jump onto this bandwagon at some point soon and make MDSAP a better return on investment for medical device manufacturers. But for now, companies are weighing the benefits of the certificate against the costs and risks associated with the quality audit equivalent of a root canal. It will be interesting to see how this one plays out.