The registration process for medical devices with oral adhesive products in Canada is as follows:
1.Determine Product Classification: Determine the classification of oral adhesive products, i.e., Category I, Category II, or Category III, in accordance with the Canadian Medical Device Regulations.
2.Preparation of application materials: According to the requirements of the Canadian medical device regulations, prepare the corresponding application materials, including product quality management system documents, product technical documents, product safety and effectiveness assessment reports, etc.
3.Submit your application: Submit your prepared application materials to Health Canada. When submitting the application, you need to fill out the medical device registration application form and pay the corresponding application fee.
4.Under review: Health Canada will review the application for compliance with relevant regulations and standards. The review process may include aspects such as technical assessment, clinical assessment, risk assessment, etc.
5.Obtaining a certificate: If the application is approved, a medical device license will be issued, allowing the business to sell the medical device in the Canadian market. The license is usually valid for 5 years and requires recertification at the end of the year.
After the above steps are completed, you can sell oral adhesive products and medical devices in the Canadian market. Please note that this process may take time and fees, and all submitted information is required to be accurate and complete.