Form 0292 2011-2025

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49 votes

The document outlines the mandate of Health Canada to ensure safe and effective use of drugs, food, medical devices, and natural health products in Canada. It provides detailed instructions for completing the Medical Device Establishment Licence (MDEL) application, including required documentation, classifications of medical devices, attestations by senior officials, and information on fees and submission processes. The document emphasizes compliance with the Food and Drugs Act and includes contact information for further inquiries.

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Versions	Form popularity	Fillable & printable
2020	4.8 Satisfied (72 Votes)
2012	4.2 Satisfied (34 Votes)
2011	4 Satisfied (49 Votes)

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We have answers to the most popular questions from our customers. If you can't find an answer to your question, please contact us.

What do medical device distributors do?

Medical device distributors are critical in managing complex logistics and supply chain processes, such as getting medical products from manufacturers to end-users. They use advanced technology and systems to track inventory, handle orders, and ensure the timely delivery of products.

How long does it take to get a medical device license in Canada?

Certification and Timeline The Medical Device Manufacturers willing to place their medical devices in the Canadian market must have MDL as well as ISO 13485: 2016. Time needed for MDL 15 Days (Class II Medical Device), Class III 75 days; Class IV 90 days.

What is MDEL?

If you sell or import any class of medical devices in Canada, you must apply for and maintain a Medical Device Establishment Licence ( MDEL ), unless you meet exemption(s) in section 44 of the Medical Devices Regulations. You must use this form to apply for an MDEL .

Do you need a license to sell medical devices in Canada?

Yes, any person who manufactures (class I), imports or sells a medical device for human use in Canada requires a Medical Device Establishment Licence (MDEL). The requirement to hold an MDEL does not depend on the quantity sold per year.

What is MDL in health?

microbial diseases laboratory branch You will be redirected within 8 seconds.

What does MDEL mean?

Medical Devices Establishment Licence (MDEL)Listing.

Who needs to have the MDEL in Canada?

In general, any person who imports into, or sells a medical device for human use in Canada requires an MDEL. However, there are exceptions. You must apply for and maintain your MDEL to ensure compliance with the act and the MDR.

What is the full form of Mdel?

Medical Device Establishment Licence (MDEL) application: instructions (FRM-0292)

Form 0292 2011-2025

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