Canada Makes Additional Adjustments to MDSAP Program

May 10, 2018

Health Canada is making further reductions in audit times for its Medical Device Single Audit Program for smaller companies with lower-risk products.

The regulator said that shorter audits could be undertaken for devicemakers that:

  • Have 100 or fewer employees;
  • Make only lower-risk products (typically Class II medical devices);
  • Use simple design and manufacturing processes using commonly available materials and established technologies; and
  • Have a good history of conformity to ISO 13485 and regulatory requirements.

For example, a manufacturer with 15 employees could see a 35 percent reduction in audit times, and one with 45 employees could see an 18 percent reduction. The additional reductions become effective June 11.

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