Canada Makes Additional Adjustments to MDSAP Program

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.