With the approaching deadline for those in Canada to comply with the Medical Device Single Audit Program (MDSAP), Health Canada issued a notice to recognize that some device makers may be cancelling their licenses to avoid dealing with the new requirements.
“It is anticipated that some manufacturers, instead of conforming to the new MDSAP requirements, may be cancelling their medical device licences and discontinuing the sale of their products as early as November 1, 2018,” Health Canada said.
The notice, quietly issued late last month, puts forth what industry has been expecting to come from the new requirements on all manufacturers of Class II, III and IV medical devices.
Small- to medium-sized device manufacturers, in particular, that are already on the Canada market have been scrambling to schedule these audits and obtain MDSAP certificates ahead of 1 January 2019, as previously reported by Focus. Others, including startups, have reportedly been in a “wait-and-see” mode on if Health Canada will ease requirements.
With the goal of addressing concerns over the delays many have experienced between when an audit is conducted and the certificate is subsequently issued, the last action Health Canada took was in April. This update informed of the regulator’s decision not to take enforcement actions against manufacturers that have yet to obtain MDSAP certificates as of 31 December 2018.
Other tweaks to the MDSAP program in Canada include reduced audit times for smaller firms. In August, the Global Diagnostic Imaging Healthcare IT & Radiation Therapy Trade Association offered potential solutions for addressing remaining concerns among its member companies.
Canada’s version of the auditing program, which has been known as the cornerstone of the International Medical Device Regulators Forum (IMDRF), has continued to face unique challenges compared to others in the MDSAP consortium. This is because Health Canada is currently the only regulator in the consortium that is phasing-in MDSAP as a requirement for manufacturers to begin or continue to legally sell their products on the market. Whether any of the other nine IMDRF countries will follow in Health Canada's footsteps remains to be seen.
But MDSAP has continued to gain momentum worldwide, despite the barriers in Canada to the overall objective of the program—providing a mechanism for manufacturers to comply with requirements in multiple jurisdictions for greater availability of and patient access to devices.
MDSAP participation in the US, which remains voluntary for interested manufacturers, has outpaced that of all other MDSAP countries, according the US Food and Drug Administration. More than half of the 2,629 total of all participating manufacturer sites worldwide are in the US, followed by Canada, Germany, Japan and China.