Medical Device Certification Registration in Canada

According to the Canadian Medical Device Regulations (CMDR), medical devices are divided into four classes (I, II, III and IV) according to the product risk levels. The risk levels are gradually increasing. Class I medical devices bear the lowest risks, and Class IV medical devices bear the highest risks. The product registration requirements for the manufacturers are also gradually increasing, and the systems required

to be practiced by the manufacturers are increasingly detailed.

If you plan to enter the Canadian market, you need to register your products to obtain a license. Health Canada issues two different types of certificates: Medical Device Establishment License (MDEL) and Medical Device License (MDL), with different requirements.

Canadian Medical Device Establishment License (MDEL)

1. What is MDEL

MDEL is the abbreviation of Medical Device Establishment License. If you plan to manufacture, import or distribute Class I medical devices in Canada, you must obtain the Medical Device Establishment License (MDEL) from Health Canada. MDEL is an operation license for the establishment. No matter which class the medical device belongs to, the medical device distributor and importer must obtain the MDEL.

2. Basic process of MDEL application

(1) The enterprise prepares the corresponding documents for applying for the Medical Device Establishment License (MDEL).

(2) The enterprise submits the MDEL application and pays the administrative fee to Health Canada.

(3) If the application is approved, it will be published on Health Canada’s website.

3. Exemption can be granted in the following cases:

(1) Retailers

(2) Healthcare enterprises

(3) Manufacturers that want to sell Class II, Class III and Class IV medical device products with the Medical Device Product Registration Certificate under the name of these manufacturers in the Canadian market (note: the manufacturers that want to sell Class II, Class III and Class IV medical device products with the Medical Device Product Registration Certificate under the name of other enterprises in the market must also apply for the MDEL).

(4) Manufacturers of Class I medical device products do not need to apply for the MDEL if they want to sell medical device products in the Canadian market through the enterprises with the Medical Device Establishment License (MDEL).

4. Validity period of the MDEL

The MDEL has no specific validity period indicated, but the holders of the MDEL must submit an annual review application before April 1 of each year, so that the MDEL can be considered to be valid; otherwise, the MDEL will be revoked.

After the MDEL is revoked, the sales activities in the Canadian medical device market will also be prohibited. If the MDEL is revoked, the MDEL holders must apply for it and pay the fee again to be able to obtain the MDEL. After successful application, a new MDEL will be issued.

5. To apply for the MDEL, you need to complete the following application form, and you can get the license 2-4 weeks after submission.

(1) Company name and contact information

(2) License document, mailing address and billing address

(3) Classification and activity schedule

(4) Site address

(5) Manufacturer information

(6) Certificate

(7) Signature

6.  Example of MDEL

Canadian Medical Device License (MDL)

MDL is the abbreviation of Medical Device License. MDL is the approval for products. If you plan to manufacture, import or distribute medical devices of Class II and above in Canada, you must obtain the Medical Device License (MDL) from Health Canada.

For Class II, Class III and Class IV medical devices, before applying for the MDL certification, the MDSAP audit certification must be completed.

1.  What is MDSAP certification?

MDSAP is the abbreviation of Medical Device Single Audit Program. It is a program co-sponsored by members of the International Medical Device Regulators Forum (IMDRF). The aim is: a qualified third-party auditing organization performs a single audit for each medical device manufacturer, so that the medical device manufacturer can meet the different QMS/GMP requirements of the participating countries.

MDSAP has replaced CMDCAS mandatorily since 2019, as the only way for the products of Class II and above to enter Canada.

2.  How to apply for the MDSAP certification

(1) The enterprise hires a professional third-party medical device service organization to establish a quality management system that meets the requirements of MDSAP:

(2) The enterprise recognizes the MDSAP regulations, and the quality management department conducts the internal audit in accordance with the MDSAP requirements;

(3) The notified body comes to the enterprise for the on-site audit;

(4) The enterprise makes rectifications based on the rectification items proposed by the notified body after the audit, and submits the rectification plan within 15 days;

(5) The notified body reviews the rectifications by the enterprise;

(6) After the audit is passed, the notified body goes through the certification approval process and issues the MDSAP certificate.

3.   Basic process of MDL application

Class II:

(1)  Pass the MDSAP audit certification and obtain the certificate.

(2)  Prepare for the Canadian Medical Device License (MDL) application.

(3)  Submit the MDL application and pay the administrative fee to Health Canada.

(4)  Health Canada reviews the MDL application and publishes the result on the website after the review is passed.

Class III and Class IV:

(1)  Pass the MDSAP audit certification and obtain the certificate.

(2)  Prepare for the Canadian Medical Device License (MDL) application.

(3)  Submit the MDL application and premarket review documents, and pay the administrative fee to Health Canada.

(4)  Health Canada reviews the MDL application and premarket review documents, and publishes the result on the website after the review is passed.

As a global technical service provider that is professional in the field of medical device regulations, SUNGO can provide the following services:

1.   Determine the specific classification of your medical device in Canada;

2.   Help you apply for the Canadian MDEL and MDL;

3.   Assist you in establishing a medical device quality management system in accordance with MDSAP;

4.   Provide the MDSAP special training services;

5.   Determine the annual license fee to be paid to Health Canada;

6.   Assist you in contacting Health Canada.

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