Gain market access in Canada with CMDR and ISO 13485 approval

Canadian Medical Device Regulations (CMDR) and ISO 13485

Canada-flagFor manufactures who wish to sell Class II, III, and IV medical devices, Health Canada requires you to provide an ISO 13485 quality system certificate as evidence of compliance to the Canadian Medical Device Regulations (CMDR). This certificate can only be issued by a Canadian Medical Devices Conformity Assessment Scheme (CMDCAS) recognised registrar such as BSI.

What are CMDR and CMDCAS and why do I need an ISO 13485 quality system?

CMDR that 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.

CMDCAS was developed by Health Canada and the Standards Council of Canada (SCC) to implement these new regulations. SCC accredits organizations that certify the management systems of medical device manufacturers. Under CMDCAS, only certification bodies accredited by SCC such as BSI are eligible to certify a medical device manufacturer’s management system to ISO 13485.

Medical Device Regulations and classification in Canada

The Medical Devices Regulations require class II, III and IV medical devices to be manufactured (class II) or designed and manufactured (class III & IV) under CAN/CSA ISO 13485:2003. There are no regulatory quality system requirements for Class I medical devices. These quality system requirements came into force on January 1, 2003. CMDR do not require importers or distributors of medical devices to have a registered quality system.

Class I devices present the lowest potential risk and do not require a licence. 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)

What is BSI's role in market access in Canada?

As an accredited registrar under CMDCAS, 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.

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

Frequently Asked Questions about CMDCAS

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.