CMDCAS for Canadian Market Access

If you are applying for a Class II, III, or IV medical device license, Health Canada requires you to provide an ISO 13485 certificate issued by a CMDCAS recognized registrar such as Intertek.

Intertek is one of the few certification bodies in the industry to have gained recognition under the Canadian Medical Devices Conformity Assessment System (CMDCAS) program for ISO 13485. In fact, we have been very active in the CMDCAS program since its inception:

  • Intertek participated in the industry working group that helped develop the CMDCAS program.
  • We were the first registrar to be approved by Health Canada to issue ISO 13485:2003 certification.
  • In 2002, we became the fourth certification body to be recognized by the Standards Council of Canada (SCC) and Health Canada to conduct audits under the CMDCAS program.
  • We maintain our CMDCAS recognition by attending regular Registration Body Forum meetings with the SCC and Health Canada, and by being audited by SCC and Health Canada on a regular basis.

Additionally, unlike most other registrars, Intertek has a long history of involvement in the Canadian market. Our first Canadian office was established in 1888, when Milton Hersey opened a small chemical testing laboratory in Montreal. More than 100 years later, in 1993, we were one of the first registrars to be accredited by the SCC. Today, Intertek remains well-established in Canada, with 21 offices and laboratories across eight provinces. Our local experts possess an unrivalled knowledge of the requirements you must meet for Canadian market access.

 
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