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.