Health Canada’s new safety audit rules are going to increase costs and expected to expel some medical devices players out of the country, the new rules are expected to bring a huge shortage of products for the patients in Canada.

The Medical Device Single Audit Program (MDSAP) of Canada, which will be compulsory for all the medical device companies from 1 Jan 2019, is going to result in huge fees for audits. The manufactures of surgical equipment, oxygen masks and medication–delivery systems, say they have been quoted fees of $30 000 to $50 000 annually, where previously the fees were between $3 000 and $5 000 yearly. The new audits will check everything right from how medical devices are designed, ordered, used and disposed of, and how the companies take actions to solve complaints, which is why the MDSAP audit program has raised audit costs, which in turn is expected to create a critical situation for small manufacturers in Canada.

 MDSAP is an international voluntary program and Canada will be the only country to make the MDSAP audit mandatory. Other countries like the United States, Australia, Japan and Brazil use MDSAP, but it is not compulsory. A Health Canada spokesperson said that other countries are considering “similar mandatory requirements and options.” In an email response to questions from The Globe, the department said that moving to MDSAP “cover[s] the way for Canadian companies to grow their business to other markets and also lower red tape for those wishing to operate in multiple markets.”

Health Canada says MDSAP auditors have to follow specific audit rules to make thing more precise to strengthen the post-market surveillance and risk management in Canada.  MDSAP will replace the current Canadian Medical Devices Conformity Assessment System (CMDCAS). Some manufacturers believe the MDSAP will put patients at risks as there will be fewer providers of medical devices if such an audit becomes mandatory. 

Health Canada believes that the change may result in longer audits and higher costs for smaller manufacturers  which is why it’s planning to reduce, for small companies, the time spent performing the audit. The authorities giving more time to the manufactures, as it’s scheduled for the end of this year. The goal is to give companies more time to adapt and help to lessen the costs of the new program. A Health Canada spokesperson also said they plan to make more adjustments to “further support small businesses” in the weeks ahead for manufacturers with fewer than 100 employees who manufacture lower-risk devices.