Gain market access in Canada with CMDR and ISO 13485 approval

The Canadian Medical Device Regulations (CMDR), which took effect on January 1 2003, are the standards that must be followed in order for manufacturers to sell medical devices in Canada. For manufacturers of Class II, III, and IV medical devices, an ISO 13485 quality system is required. These devices must be audited every year by a recognized Certification Body under CMDCAS. 

Class II devices require the manufacturer’s declaration of device safety and effectiveness, whereas Class III and IV devices present a greater potential risk and are subject to in-depth scrutiny.  A guidance document for device classification is published by Health Canada.

Canadian classes of medical devices normally correspond to the European Council Directive 93/42/EEC (MDD) devices, there may be exceptions:

• Class IV (Canada) generally corresponds to Class III (ECD)
• Class III (Canada) generally corresponds to Class IIb (ECD)
• Class II (Canada) generally corresponds to Class IIa (ECD)
• Class I (Canada) generally corresponds to Class I (ECD)

There are no regulatory quality system requirements for Class I medical devices. CMDR also do not require importers or distributors of medical devices to have a registered quality system.

The Canadian Medical Device Conformity Assessment Scheme (CMDCAS) under which the past ISO 13485 certificates were issues has been replaced by the the Medical Device Single Audit Program (MDSAP). Health Canada have announced that MDSAP will replace the CMDCAS system, effective January 2019. Any manufacturer wishing to sell devices into Canada will need to be certified under MDSAP.

The Medical Device Single Audit Program (MDSAP) allows manufacturers to undergo a single audit to meet the QMS/GMP requirements of multiple Regulatory Authorities (RAs).

Health Canada is a participating RA, having completed the three year pilot phase of the Program, which ended in December 2016. In  December 2015, Health Canada announced that it will use only MDSAP audits, replacing CMDCAS as the mechanism to achieve regulatory compliance for quality management system requirements in Canada. Manufacturers must have transitioned to MDSAP by January 2019.

MDSAP audits are conducted by recognized Auditing Organizations (AOs); BSI is a recognized AO and participated in the Program's pilot phase.

Find out more about the Program, who is involved and BSI's role now.

Listen back to our recent MDSAP webinar, which details next steps for market access in Canada.

We audit medical device companies worldwide to ensure proper registration, quality system compliance and distribution. Navigating the regulatory processes for medical devices can be a challenge, and we can support you as you understand the regulations and get compliant, allowing you to make an impact in the marketplace.

BSI is also a recognized Auditing Organization (AO), so can continue to support your market access requirements throughout the transition to MDSAP and beyond. 

Our core competencies and unique skills are calibrated to handle our customer’s extensive portfolio of medical technologies which include:

Are you concerned about successfully transitioning your business into the Canadian marketplace? We often answer these kind of questions from our customers, and you can always contact us for more information.

Q.    Will my company actually sell products in Canada?

A.    Health Canada distinguishes between companies that sell medical devices and those that are, for example, contract manufacturers, sterilizers, design houses or services companies. Such companies only require a ISO 13485 certificate; CMDCAS certification is required only for medical device manufacturers that are selling products in Canada.

Q.    Can I leave out Design Control if I only have Class II products?

A.    Yes. However, BSI strongly advises that all companies who are design-responsible include Design Control in the scope of registration.

Q.    Do my labels have to be in both French and English?

A.    For most devices, only English is required as the main language on labels and instructions for use. Both languages are required for some devices, however, and companies should be able to demonstrate that they are capable of producing a label and the IFU in French.

Q.    Does BSI submit my certificate to Health Canada?

A.    No. Submitting the certificate is always the manufacturer’s responsibility, but BSI is very proactive on certificate change requests (which occur frequently with CMDCAS certificates).

Q.    Will BSI send my report with all findings to Health Canada?

A.    Yes. If Health Canada requests any company’s report, we are obligated to send this to them.