Enabling you to identify and mitigate the intrinsic risk in your operations, supply chains and business processes.
Evaluating how your products and services meet and exceed quality, safety, sustainability and performance standards.
Validating the specifications, value and safety of your raw materials, products and assets.
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:
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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