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Kim Vopni, the Canadian importer of the EPI-NO through her Port Moody, B.C.-based company Pelvienne Wellness Inc., said some of her customers are devastated.

BEN NELMS/Globe and Mail

Hundreds of different types of medical devices are being pulled from the Canadian market because of a new Health Canada safety audit that some manufacturers argue is too costly to carry out.

While Health Canada says most of the manufacturers leaving have little or no sales in the country, distributors say patients could be left without necessary devices and their health could be jeopardized.

The Medical Device Single Audit Program, which becomes mandatory on Jan. 1, is a new set of rules Health Canada says harmonizes the system with other countries and will "strengthen the post-market surveillance and risk management of medical devices in Canada.”

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Under MDSAP, medical equipment makers say they’re being forced to pay significantly higher costs compared with the old audit system. The costs vary depending on the size of the company, but many were quoted fees of roughly $30,000 to $50,000 annually for an audit that used to cost between $3,000 and $5,000 a year. The higher price tag is said to be because of the more intensive MDSAP audit program and a shortage of third-party auditors able to do the work.

One product being pulled is the EPI-NO (which stands for no episiotomy) device from German-based manufacturer Tecsana GmbH, which helps pregnant women strengthen and stretch their pelvic floor muscles to prevent injury during childbirth.

Ms. Vopni holds a Epi-No product at her office in Port Moody, B.C., on Dec. 11, 2018.

BEN NELMS/Globe and Mail

Kim Vopni, the Canadian importer of the product through her Port Moody, B.C.-based company Pelvienne Wellness Inc., said some of her customers are devastated.

"It’s a very innovative product that has helped so many women. The fact that it's no longer going to be available here in Canada breaks my heart,” said Ms. Vopni, who has been distributing the product for 14 years, after using it herself in 2004.

Tescana has decided to stop selling in Canada in 2019 after the cost of the new MDSAP audit alone more than doubled compared with the old system. The company said it was too much, alongside the cost of broadening of its existing quality management system, to justify sales of the product in Canada.

Ms. Vopni announced to her clients a couple of months ago that she would have to stop carrying the product and has seen a rush on orders before the end of the year. Some customers are even buying it for when they get pregnant in the future, she said.

Roger Chute, product manager at Langley, B.C.-based Carestream Medical Ltd., which distributes medical equipment for use in hospitals and ambulances, said the problem with the Health Canada’s implementation of the MDSAP program is that no other country is making it mandatory. MDSAP remains a voluntary program in countries such as the United States, Australia, Japan and Brazil.

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“So current certifications will still be valid for the other countries but not for Canada,” Mr. Chute said. “It starts to look like a bad investment to pay for access to Canada unless you have substantial business in Canada such that your profits can cover these costs."

Mr. Chute said about a dozen of his manufacturer partners have decided to withdraw from the Canadian market. “Others that were considering coming to Canada have chosen not to."

He believes health care will “suffer under the MDSAP program as equipment and treatment options currently available are withdrawn or those available elsewhere are not available to our physicians, nurses and paramedics.”

The EPI-NO (which stands for no episiotomy) device from German-based manufacturer Tecsana GmbH, helps pregnant women strengthen and stretch their pelvic floor muscles to prevent injury during childbirth.

BEN NELMS/Globe and Mail

In an e-mail on Dec. 10, a Health Canada spokesperson told The Globe and Mail that about 78 per cent of manufacturers have either initiated or completed the transition to MDSAP as of Dec. 6. Health Canada also said manufacturers holding a total of 403 medical device licences indicated to the department they were “withdrawing their products from Canada because of MDSAP." The department said most of them “had very low sales or no sales in Canada,” and added that between 1,200 and 1,600 licences are cancelled or withdrawn annually, “for a variety of reasons.”

Health Canada said it has already addressed concerns about MDSAP by enabling a smoother transition process and reducing the duration of audits for smaller companies. The department said it has been doing risk assessments on MDSAP – which replaces the former Canadian Medical Devices Conformity Assessment System program – and its results show most devices that will no longer be available on the market have “potential licensed alternative devices.” In cases where there would be no suitable alternative devices, Health Canada said Canadians could possibly get access to unlicensed devices by applying to the Special Access Program, which allows physicians to legally gain access to medical devices not licensed for sale in Canada.

Brian Courtney, a physician in Toronto, said he’s not seeing any products come off the shelves in his practice as a result of the new MDSAP audit process. However, he said many of the devices he uses are sold in higher-volume that makes the extra audit costs easier for those manufacturers to absorb. “It’s some of the more specialized companies that are at higher risk,” of being removed from the Canadian market, he said.

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Dr. Courtney is also president and CEO of Toronto-based Conavi Medical Inc., which provides imaging technology for cardiovascular procedures; it has been through the MDSAP audit. He said it was costlier and more time-consuming than the old program but believes the process will be less onerous in the years to come. “I don’t think in the long-term it will be a bad thing,” Dr. Courtney said, adding that it could be a few months before the impact of the new audit process is felt.

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