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This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act the Regulations and the applicable administrative policies. The following describes the process for completing the Medical Device Establishment Licence MDEL application form* Step 1 Read the Guidance on Medical Device Establishment Licensing and Medical Device Establishment Licence Fees GUI-0016. Guide 0016 can be found on the Health Canada website at http //www. hc-sc*gc*ca ...

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How do I get MDEL?

Step 1: Learn about MDEL s. ... Step 2: Determine if your product is a medical device. ... Step 3: Determine if your activities require an MDEL. ... Step 4: Register as a small business (if applicable) ... Step 5: Complete the application form. ... Step 6: MDEL fees. ... Step 7: Submit your application.

What is the difference between MDL and MDEL?

A Canadian Medical Device License (MDL) is required for companies selling Class II - IV medical devices in Canada. The MDL is a product approval, while a MDEL is a permit for the company/distributor/importer itself. Obtaining an MDL is comparable to the US FDA 510(k) process.

Do I need an MDEL Health Canada?

In general, any person who imports into, or sells a medical device for human use in Canada requires an MDEL (see exceptions). You must apply for and maintain your MDEL to ensure compliance with the Food and Drugs Act and its Medical Devices Regulations.

What is an MDEL?

A Medical Device Establishment Licence (MDEL) is issued for the activities of manufacturing (class I), importing or distributing (selling) medical devices for human use in Canada.