Access to the Canadian market
Certification according to Canadian regulations
Statutory context
Under Canada’s Medical Devices Regulations (MDR), medical device manufacturers must prove their quality management system meets the requirements of Canadian standard CAN/CSA ISO 13485 for Class II, III and IV devices (Canadian classification).
The quality system must meet specific MDR requirements, and must be certified by a body called a registrar. The registrar is accredited by the Standards Council of Canada under the Canadian Medical Devices Conformity Assessment System (CMDCAS) and is recognized by Health Canada (the Canadian Ministry of Health).
LNE/G-MED is recognized by Health Canada as a registrar.
Under the CMDCAS programme, LNE/G-MED issues the quality system certificates required by manufacturers when applying to Health Canada for a medical device licence.
LNE/G-MED is involved in the Pilot Audit Program (PMAP)developped by FDA (USA) and Health Canada. LNE/G-MED can be requested by medical devices manufacturers to carry out simultaneously :
- audit according to ISO 13485:2003 and related provisions of the Canadian Medical Devices Regulations
- inspections according to the U.S. Quality System Regulations 21 CFR Part 820
For more information, please consult Health Canada and FDA websites.
Useful links
- Canadian Medical Devices Regulations (MDR)
- Health Canada licence application information
- Health Canada
For information on the LNE/G-MED certification process, see the section Obtaining certification