Smaller Medical Device Companies May Qualify for a 35% Reduction in MDSAP Audit Duration…If They Meet These Four Criteria

May 1, 2018

On October 31, 2017, Health Canada announced new guidelines intended to reduce some of the burden that the new MDSAP rules placed on smaller medical device companies. At that time, they promised a 10-20% reduction in audit times for companies with fewer than 45 employees.

However, it seems industry was unimpressed with those efforts, because now Health Canada is recommending even more changes to all members of the MDSAP Consortium (Australia, Brazil, Canada, Japan, US).

These changes affect the duration of audit times for certain medical device manufacturers.

The Canadians are not waiting around to see what happens

In suggesting these changes, the Canadians are presumably worried about an exodus from the Canadian market. They have a very real need to make sure that the Canadian market remains competitive, and that means they need a constant flow of new technology into the market. A sizeable portion of new med tech certainly originates from Canadian companies, but a big chunk also comes from US companies. If small US medical device companies, in particular, find it too burdensome to comply with MDSAP and Canadian requirements, they may postpone or skip the Canadian market altogether – not good for Canada. Canada fully recognizes that they have the most to lose if smaller American medical device companies pull out, more so than larger markets such as the US, Japan, or Brazil.

Qualification criteria for shorter MDSAP audit times

To their credit, Health Canada has taken a leadership role in recommending further changes intended to ease the pain, especially for very small device companies. Health Canada’s Medical Devices Bureau is recommending that all member Auditing Organizations (AOs) grant reductions in audit duration if a medical device manufacturer meets these criteria:

 1. Has fewer than 100 employees and…
 2. Makes only lower-risk devices (typically NOT Class III or IV in Canada) and…
 3. The product has a simple design and manufacturing process using common materials and well-known technologies, and
 4. The company has a good track record of conformity with ISO 13485 and regulatory requirements

How much of a reduction in MDSAP auditing times?

Small companies will see the most benefit and the greatest reduction in audit times. Generally, Health Canada has provided the following examples, assuming criteria 2, 3, and 4 above are met:

  • A company with 15 employees could expect up to a 35% reduction in audit duration
  • A company with 45 employees could expect up to an 18% reduction in audit duration
  • A company with 85 employees could expect up to a 10% reduction in audit duration

Overall, these changes are good news for small companies and a step in the right direction. The changes will take effect on June 11, 2018. If you have questions about the audit reduction times, you can email Health Canada’s Medical Devices Bureau at qs_mdb_hc@hc-sc.gc.ca or call them at 613.957.4786.

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