Get New Class Ii Medical Device Licence Application Form

This guide provides comprehensive instructions on how to complete the NEW CLASS II MEDICAL DEVICE LICENCE APPLICATION FORM online. By following these steps, users can ensure they accurately fill out the form required for licensing their medical devices.

Follow the steps to successfully complete your application.

1. Click ‘Get Form’ button to obtain the form and open it in the editor.
2. In the first section, enter the name of the device exactly as it appears on the label.
3. Provide manufacturer information. Fill in the contact name, title, company ID (if known), company name, telephone numbers, email, and address details all as they appear on the label and Quality Management System certificate.
4. Complete the Regulatory Correspondent Information section. You can indicate if this information is the same as the manufacturer or specify alternative contact details.
5. Fill in the Invoicing Information. Again, indicate if it's the same as the Regulatory Correspondent or provide new details.
6. Attach the Quality Management System certificate and provide the certificate number and name of the registrar.
7. In the Attestations section, check the relevant statements regarding compliance with Medical Devices Regulations. Ensure to complete this section carefully, as it requires truthful declarations by a senior official.
8. Describe the purpose/intended use of the device as stated in the labeling. Include document references that support this information.
9. Select the licence application type by checking one of the options provided: single device, test kit, system, etc.
10. Indicate relevant information about the place of use, answering questions regarding home use and if the device is an In Vitro Diagnostic Device (IVDD).
11. Address additional questions about drugs if the device contains any, and include necessary identification numbers if applicable.
12. Provide details regarding the device's history and whether it has previously been authorized for sale in Canada.
13. Complete the device identifier section for each device listed, including any necessary checkmarks regarding substance compliance.
14. List all compatible devices intended for use with the Class II medical device and their respective licence numbers.
15. Indicate if the device meets recognized standards, providing details as applicable.
16. Confirm that the labeling material is included as an attachment, as required.
17. Ensure the Medical Device Licence Application Fee Form is included with the application.
18. Complete the Licence Application Disclosure Request by providing consent regarding information disclosure, if necessary.
19. Review all entered information thoroughly for accuracy before submitting the application.
20. Finally, you may save changes, download, print, or share the completed form as required.

Complete your NEW CLASS II MEDICAL DEVICE LICENCE APPLICATION FORM online today for a smooth licensing process.