ANSWERED ON THIS PAGE:
- What is the medical device registration process in Canada?
- What is the difference between an MDEL and an MDL?
- Does our ISO 13485 certification meet QMS requirements in Canada?
Complying with Canada's Medical Device Single Audit Program (MDSAP) and included regulations
With a population of more than 36,000,000 and a well-organized national healthcare system, Canada is a lucrative market for medical device manufacturers.
Before you can market your medical device in Canada, you must comply with the Medical Device Single Audit Program (MDSAP), which includes compliance with the quality management system (QMS) requirements of the Canadian Medical Devices Regulations (CMDR) and obtaining the required level of approval from Health Canada.
Health Canada medical device licensing
In Canada, you are required to obtain a Medical Device Establishment License (MDEL) if you intend to market your Class I device, or a Medical Device License (MDL) for your Class II, III or IV device. If you intend to distribute licensed medical devices into Canada, you will require a MDEL.
Your MDL or MDEL application must be in full compliance with the CMDR and be submitted to Health Canada in conjunction with the appropriate documentation required for your device class.
Health Canada CMDR Quality System Requirements and ISO 13485
Health Canada requires manufacturers of Class II - IV medical devices to meet the QMS of ISO 13485 under MDSAP which includes compliance with the requirements of the CMDR. Before your device can be sold in Canada, your compliant QMS must undergo an audit by an MDSAP-accredited Auditing Organization (AO).
Let us assist with ISO 13485 and MDSAP Regulatory Compliance
With consultants across the country, Emergo specializes in helping medical device and In Vitro Diagnostic (IVD) manufacturers meet MDSAP requirements so they can gain access to the Canadian market. Here's why you should choose us:
- We can help you implement or modify your ISO 13485 quality system so that you are in full compliance with MDSAP (including the CMDR).
- We will complete and file the Canadian Medical Device License (MDL) or Medical Device Establishment License (MDEL) application on your behalf.
- We can provide onsite employee training and auditing on ISO 13485, MDSAP and the CMDR.
Our experienced consultants have assisted hundreds of medical device companies with Health Canada licensing, MDSAP and CMDR compliance.
Emergo by UL can provide eQMS support in strategic alliance with Greenlight Guru. This helps you leverage an eQMS system designed specifically for the medical device industry. Ask us to schedule a demo so you can explore a software solution that connects with your processes, people, and data.
Common MDSAP & CMDR questions
What are the QMS requirements for Class I devices in Canada?
There is no requirement to implement a full QMS that is certified to ISO 13485; however, you are obligated to implement a limited set of quality procedures (e.g. related to product recall). If your medical device is Class II - IV, you must demonstrate compliance with ISO 13485 under MDSAP.
Can our existing Notified Body audit us for compliance under MDSAP?
Possibly. Most ISO Registrars are also European Notified Bodies, but not all Notified Bodies are MDSAP-accredited AOs. See if your Notified Body is on this list.
Does the CMDR specify any Country of Origin requirements?
There is no requirement in the CMDR that a company must obtain approval in their own country (the country of origin) as a prerequisite to registration in Canada.