Get Canada Frm-0292 2020-2026

The Canada FRM-0292 form is essential for applying for a Medical Device Establishment Licence. This guide provides step-by-step instructions to assist users in completing the form accurately and efficiently.

Follow the steps to complete the Canada FRM-0292 online.

1. Click ‘Get Form’ button to obtain the form and open it in your preferred digital format.
2. Select the type of application you wish to submit: New licence application, Notification, Amendment of an existing application, Reinstatement, or Cancellation. Ensure to check the appropriate option.
3. Complete Section 1: Application Type. Enter your current Medical Device Establishment Licence (MDEL) number if applicable, and any previous MDEL numbers held by your establishment.
4. Proceed to Section 2: Applicant Information. Fill in your establishment name, operating name, and complete the small business mitigation section as applicable.
5. In Section 2.1, provide the establishment address where licensable activities are conducted, ensuring no P.O. Box is used. Fill in all required fields accurately.
6. Complete Section 2.2 with the contact person's information for the establishment licence. Ensure all contact details, including email and phone number, are provided.
7. Move to Section 3: Activities. Select applicable activities your establishment engages in and the class of devices for which you are applying.
8. In Section 4: Site Information, list any additional sites used by your establishment and indicate the documented procedures in place at each site.
9. Fill out Section 5: Manufacturer or Supplier Information for each manufacturer or supplier connected to your medical devices, including their details and risk class.
10. Proceed to Section 6: Attestations. Carefully read each attestation statement and select all relevant options pertaining to your establishment's procedures.
11. Finish with Section 7: Signature. The senior official must sign, print their name and title, and date the application to acknowledge the accuracy of the information provided.
12. After completing the form, you can save changes, download, print, or share the completed FRM-0292.

Complete your application for the Medical Device Establishment Licence online today.