The Requirements of Importing Dental Equipment(2/3)

Canada

CMDCAS for dental device imports to Canada

All dental equipment entering the Canadian market, whether manufactured locally in Canada or imported, are required to obtain approval from Health Canada, Canada’s medical device authority, for evaluation under the CMDCAS.

Health Canada requires that all medical device manufacturers entering the Canadian market be certified by CMDCAS (Canadian Medical Device Conformity Assessment System) to demonstrate compliance with Canadian medical device regulations. Canada’s medical management has a product registration system.

Unlike the United States and the European inspection system (CE certification), Canada has a government registration combined with a third-party quality system review. The term “third party” refers to a third party organization accredited by the Standards Council of Canada (SCC) to conduct Canadian medical device conformity assessment system audits.

Medical devices are classified into four categories: I, II, III, and IV according to the risk of use of the device. For this reason, the product registration requirements for manufacturers are increasing step by step, and the system required of manufacturers is more and more detailed.

The basic process of registration

Class I

1. Prepare the appropriate technical documents for the application of Medical Device Establishment License (MDEL).
2. Submit the MDEL application and pay the Ministry of Health administrative fee.
3. Application evaluation is approved and will be publicized on Health Canada website.

Class II

1. Pass the ISO 13485 audit certification by the CMDCAS accredited certification body (system audit includes special requirements of CMDR in addition to ISO 13485 requirements) and obtain the certificate.
2. Prepare Canadian Medical Device License (MDL) application.
3. Submit the MDL application and pay the administrative fee of Ministry of Health.
4. Health Canada will review the MDL application and publish it on the website after the review.

Class III, IV

1. Pass the ISO 13485 audit certification by CMDCAS accredited certification body (system audit includes special requirements of CMDR in addition to ISO13485) and obtain the certificate.
2. Prepare Canadian Medical Device License (MDL) application.
3. Submit MDL application and Premarket review documents, and pay the administrative fee of Ministry of Health.
4. Health Canada assesses the MDL application and Premarket review documents, and publicizes them on the website after the assessment.