As originally asked by Yasser Mohammad.

Yasser Mohammad
Associate Project Manager, Professional Services – LifeSciences at Paradigm IT Group
Thank you Dan and Robert. Appreciate your time and valuable inputs.

Rob Packard
510(k), CE Marking & Quality System Consultant
Hi Yasser. To expand upon Dan’s comment, the regulations for classification of Canadian Medical Devices are defined in the Canadian Medical Device Regulations. You can download this document for free at: [http://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/index.html|leo://plh/http%3A*3*3laws-lois%2Ejustice%2Egc%2Eca*3eng*3regulations*3SOR-98-282*3index%2Ehtml/ngeS?_t=tracking_disc]. Notified Bodies and Registrars are not allowed to provide guidance on this. Instead, Health Canada prefers to work directly with the company to determine the classification. Most experienced regulatory consultants can help you determine the most likely classification based upon the regulation rules, but you should confirm the classification directly with the Device Licensing Group in Canada. There is no charge, and they will respond by email with a formal response within 10 days.

Dan O’Leary
President at Ombu Enterprises, LLC
No. The Canadian classification rules are not the same as the EU classification rules for medical devices in the MDD. They both use a similar rule-based approach, but could classify the same device in different risk classes.

With that said, the risk classes are also different. In the EU, they are I, IIa, IIb, and III. In Canada, they are I, II, III, and IV.

For IVDs, the rules are not similar between the two regulatory jurisdictions.

Regards,
Dan

Tony Liu
Marketing at XinChen Hardware & Plastic Products Company
Different countries Regulations are difference. I think Europe’s Regulations will more strictly