Industry committee  The MDSAP audit is a regular audit. People have annual audits as part of the MDSAP program. For the MDEL, depending on whether you're a manufacturer or an importer and distributor, it will be two- to four-year cycles. You have two cycles going, but when the two coincide, and we'r

Industry committee  It's a bit more active than that. For the MDSAP audit, the inspectors will go out into the warehouse and pull product. They will verify that those products are labelled according to the regulations and manufactured according to the regulations. If it's the actual manufacturer tha

Industry committee  The department that's responsible for the medical device establishment licence is one department, whereas the MDSAP quality audit system is under the medical devices bureau as opposed to the inspectorate, so there are two departments. We're currently working on a proposal to brin

Industry committee  To your point about the surgical database, that went online just at the end of last month, which was actually much sooner than predicted in the action plan. It had quoted December of this year for that to be available. We know that Health Canada had been working on that database

Industry committee  Thank you. I'll take that question, if I may. One of the things with the MDSAP audit was that it's a great idea. The idea is that one audit could potentially get you approvals from a quality system perspective for five different jurisdictions at the same time, thereby reducing t

Industry committee  The difficulty is that regulations take a long time to promulgate and bring to fruition, and sometimes you really need to be able to adapt to changing circumstances more quickly. With a guidance, you don't have to go through the Canada Gazette process, which automatically makes