EMERGO SUMMARY OF KEY POINTS:

• Medical Device Single Audit Program (MDSAP) audit timeframes have been reduced in response to industry feedback received by Health Canada.
• MDSAP audit time reductions will primarily target smaller medical device companies with limited regulatory compliance resources.
• All MDL holders active in the Canadian market will have to comply with MDSAP by early 2019.

Medical Device Single Audit Program (MDSAP) managers have overhauled their auditing approach to reduce timeframes for manufacturers in markets participating in the program.

According to a new notice from Health Canada, changes to MDSAP audit timeframes were implemented in response to comments from Medical Device License (MDL) holders regarding costs and resources related to MDSAP compliance that will become a requirement starting January 1, 2019 in Canada; Health Canada is currently the only medical device regulator that will require medical device companies under its oversight to participate in MDSAP. However, the audit timeframe changes will apply to qualifying manufacturers in all five particpating MDSAP markets (Canada, the US, Australia, Brazil and Japan). The changes primarily target smaller medical device companies with fewer resources to dedicate to MDSAP compliance.

Changes to MDSAP audit durations

Based on feedback from MDL holders to Health Canada, the MDSAP Consortium made the following changes to quality system and annual surveillance audit timeframes:

• 10% reduction in audit times for companies with 45 or fewer employees
• 20% reduction in audit times for companies with 15 or fewer employees
• 20% reduction in surveillance and MDSAP re-certification audits for all companies
• Clarification of expectations and requirements for annual surveillance audits

The Health Canada notice states that the MDSAP Consortium plans additional efforts to reduce audit timeframes and improve program efficiencies, but no dates for these measures has been announced.

Canadian market entry costs on the rise

The MDSAP notice comes after Canadian regulators recently proposed massive fee increases for MDL applications and related market entry processes. Coupled with increased compliance costs for MDL holders transitioning to the new ISO 13485:2016 quality standard, these fee increases will make it substantially more expensive for medical device companies to commercialize in Canada. So, according to Ken Pilgrim, Director of RA & QA at Emergo in Vancouver, the announcement on reducing MDSAP audit times should be a welcome gesture for manufacturers.

“With the costs of compliance increasing due to the transition to ISO 13485:2016, the implementation of MDSAP and the upcoming changes in Europe with the new Medical Devices Regulation and In-Vitro Diagnostics Regulation, it has become particularly tough for small medical device companies to continue to operate in Canada, especially since we are the only jurisdiction where MDSAP is a mandatory requirement for licensure,” explains Pilgrim.

“With that, it is good to see that Health Canada has been listening to these concerns, and has reacted with a supportive strategy. Nobody wants to see health care costs increase, so this change to MDSAP will assist these smaller companies in maintaining a competitive position in the marketplace.”

Related Health Canada and MDSAP resources:

• Health Canada Medical Device License (MDL) consulting
• MDSAP, CMDCAS and Health Canada ISO 13485 quality compliance support
• ISO 13485:2016 consulting and gap analysis
• Whitepaper: Health Canada MDL application preparation
• Whitepaper: Canadian quality management system compliance
• Video overview: Canada’s medical device registration process