Clinical requirements
Health Canada's requirements for clinical research on medical devices refer to GHTF's requirements for Clinical Research on Medical Devices. Canada generally endorses FDA clinical data due to racial and cultural similarities with the United States.
Quality supervision
Health Canada is the medical device authority in Canada, and its quality system requirements are based on the Canadian Medical Device Act and ISO 13485:2003. Quality System Certificate (CAN/CSA-ISO13485: 2003) issued by a third party accredited by THE Canadian Certification and Accreditation Agency (CMDCAS), valid for 3 years, Charge the same as the European Union with certification bodies, manufacturers of product risk level, technical documents, the complexity of the production process, the number of enterprise personnel and scale of different and different. It is important to note that when the manufacturer's quality system certificate is updated, health Canada should be notified within 30 days.
Post-marketing management of Medical device products in Canada includes: testing using the CMDCAS policy; Class ⅱ, ⅲ, ⅳ products always implement quality system (QS); Establish adverse event supervision and management system.
Market access
Health Canada requires Medical Device manufacturers to meet the requirements of the quality System, and they are certified by the advertised institution recognized by Canadian Medical Device ConformityAssessment System (CMDCAS). Manufacturers of class ⅱ, ⅲ and ⅳ medical devices must have their quality management systems audited by a notified body recognized by Health Canada to the CAN/CSA ISO 13485 quality system. After passing the quality system certification, apply to Health Canada for the Medical Device License for product registration. If you have not obtained the Canadian product Registration certificate after 18 months, the quality system certificate will be revoked.
According to the risk classification and characteristics of the products, prepare the application documents according to the list of submission documents of class ⅱ, ⅲ and ⅳ, and submit the corresponding application documents to Health Canada. Generally, the review opinions will be submitted within 1 to 2 months, and the approval will be approved within 3-6 months. The audit in Canada is basically divided into four steps, each step may ask questions, and the deadline for replying to questions is generally between 10 and 30 days. There are only 2 chances to reply to each session, otherwise the registration will be rejected. Upon certification, Health Canada will email an electronic version of the certificate and a hard copy of the certificate, submit an application for renewal or cancellation of the certificate each year, and pay an annual retention fee. If your annual sales in Canada do not exceed $20,000, you can apply for a fee discount. The annual fee is based on the number of certificates.
Health Canada issues certificates and updates the device's id number on the database. The Canadian certificate has no validity period and is required every year. However, if product changes are involved, the application for change needs to be submitted. The certificate number will only update the issuing date, and the certificate number will not be changed.
Enterprise product registration information can be found on the Health Canada website. Medical Device Establishment License is required for Category I products, 357CAD for Category II products, 5151CAD for Category III products, and 11985CAD for Category iv products. Communication with auditors is usually done by email or phone, without the need to register as an agent.
HC Process Description Process description
note
1. Determine whether the device is a medical device according to the definition of Canadian regulations
Refer to Canadian Regulation SOR/98-282
2, complete the Canadian ISO13485 quality system certification, can begin to do product registration.
Refer to Canadian Regulation SOR/98-282
3. Classify the products into ⅰ, ⅱ, ⅲ and ⅳ categories
Generally only classes ⅱ, ⅲ and ⅳ need to be registered.
Fees for the Review of Medical Device License Applications
4. After classifying the risks of the products, submit documents according to the categories. By category, the guide submits a list of documents corresponding to the requirements.
Reference Guide:
How to Complete the Application for a
New Medical Device Licence
5. Prepare application documents according to the list of documents submitted by class ⅱ, ⅲ and ⅳ.
Reference Guide Document
How to Complete the Application for a New Medical Device License
6, submit the document to Health Canada, generally within 1 ~ 2 months to put forward the review opinion, approved within 3 ~ 6 months. The audit in Canada is basically divided into four steps, each step may ask questions, and the deadline for replying to questions is generally between 10 and 30 days. There are only 2 chances to reply to each session, otherwise the registration will be rejected.
Management of Applications for Medical Device Licenses and Investigational Testing Authorizations
7. After being certified, Health Canada will email an electronic version of the certificate and a hard copy of the certificate.
The certificate is permanent and applies only to the products certified at the time.
8. Canada regularly updates its database. Anyone can search for approved registration information through a query
9. After completion, if the product involves any change, the application for change shall be submitted. The process restarts.
Guidance for the Interpretation of Significant Change of a Medical Device
10. The application for certificate retention or cancellation shall be submitted every year, and the annual fee for certificate retention shall be paid. If your annual sales in Canada do not exceed $20,000, you can apply for a fee discount. The annual fee is based on the number of certificates.
