Most companies in the Canada market were able to meet the 1 January deadline to complete the transition into the Medical Device Single Audit Program (MDSAP), according to Canada’s MEDEC.

"We have been flooded with transition packages and we're going through all of them," Ian Sullivan, regulatory affairs specialist at Health Canada' Medical Devices Bureau, told Focus.

The stack of transition packages has taken priority over calculating the final statistics on exactly how many companies completed the transition into Canada's MDSAP. "We hope that by 1 February we will have a good idea for how many are left outstanding," Sullivan said.

The transition for those in the Canada market was expected to be more challenging compared to other markets in the MDSAP consortium. Health Canada’s MDSAP differed from other regions in the consortium in that it is the only model designed to base determinations on class II, III and IV licenses on valid MDSAP certificates, which makes the program mandatory to legally sell such devices in Canada.

The concerns with a mandatory MDSAP framework resulted in some smaller companies reportedly delaying entry into the Canada market while others planned an exit. It had been “anticipated that some manufacturers, instead of conforming to the new MDSAP requirements, may be cancelling their medical device licenses and discontinuing the sale of their products,” Health Canada said last October.

The association representing Canada’s medical technology companies, MEDEC, indicated that the decision to make MDSAP a requirement in Canada did not deter most members from the transition.

“We're pleased that the majority of companies have now transitioned to MDSAP and that Health Canada has taken actions to address challenges with the transition to this new program,” Gerry Frenette, head of communication at MEDEC, told Focus. “We understand that Health Canada is continuing to engage with some remaining companies around this transition.”

Sullivan was pleased with the progress also. "We have had a good response with the transition," he said. For manufacturers that are still on the fence, Sullivan confirmed Health Canada continues to reach out to see if there is anything that can be done to get them on board. Yet most of the device licenses previously issued among those that decided against transitioning into MDSAP have now been cancelled, Sullivan added.

Background

MDSAP is known as a cornerstone of the International Medical Device Regulators Forum (IMDRF) and the inconsistencies in MDSAP model designs, including the framework for implementation, have raised concerns among industry associations. Health Canada worked to adopt certain changes to its MDSAP model that were centered on facilitating the transition, particularly for small- to mid-sized companies.

Manufacturers were originally required to submit MDSAP certificates to the Medical Devices Bureau by 31 December 2018, but the latest changes allowed for the transition into MDSAP to take place via surveillance audits. These changes—implemented by Health Canada last April—clarified that no enforcement action would be taken against those that had yet to receive MDSAP certificates by the end of 2018 as long as there was evidence to support that they underwent an MDSAP audit in 2018.

The April 2018 adjustments to Health Canada’s MDSAP transition came as the regulator recognized some manufacturers were facing challenges in scheduling MDSAP audits “as there is often a delay between the timing of the audit and the issuance of the certificate.” MEDEC is among those that raised concerns with scheduling.

Others include the Global Diagnostic Imaging Healthcare IT & Radiation Therapy Trade Association (DITTA). DITTA recently sent a letter to the US Food and Drug Administration (FDA), copying Health Canada, that highlighted some of the issues facing industry. DITTA member companies cited “long wait times to schedule audits and receive audit results or certificates,” said Patrick Hope, chair of DITTA. Yet most companies in Canada had already transition into MDSAP prior to the last MDSAP stakeholder day.

Health Canada reported at the MDSAP stakeholder day that 75% of manufacturers had transitioned into MDSAP, though the required information was still being submitted. On the measures implemented over the past two years to mitigate the impact of the transition, the regulator said that its goal is to “support the on-going delivery of healthcare services while facilities adjust to changing device availability.”

The idea for a harmonized single audit model was centered on allowing participating manufacturers to satisfy regulatory requirements across multiple jurisdictions. At least one regulatory agency in the MDSAP consortium—FDA—has indicated it does not intend to enforce MDSAP participation for medical devices on the US market. Other markets currently covered by the consortium include Japan, Brazil and Australia.

“We recognize that while MDSAP provides efficiencies in the audit process for many companies that provide products to multiple MDSAP consortium countries, for a small number of companies, this initiative provides an impediment to the Canadian marketplace,” argued Frenette.

Still, MDSAP has continued to gain momentum after being implemented in 2017 across all five countries that joined the consortium nearly five years ago. Data shared by FDA’s Center for Device and Radiological Health (CDRH) at AdvaMed’s 2018 MedTech Conference showed that MDSAP had reached a total of 2,629 participating manufacturer sites worldwide as of last September. More than 50% of the participating sites were reportedly located in the US, followed by Canada, Germany, Japan and China.

CDRH recently touted a 243% increase in the annual number of foreign medical device inspections that agency investigators conducted between 2007 and 2017, citing “nearly 600 MDSAP audits from 2013 to 2017.” Yet industry participation remains voluntary across MDSAP markets, with Canada being the sole exception.

“As more countries recognize the MDSAP audit, the utility of the program will continue to increase,” Frenette noted. “MDSAP was written into the USMCA [United States-Mexico-Canada Agreement] sectoral annex on medical devices, which means that Mexico may soon recognize it as well.”