Get the free Medical Device Establishment Licence (MDEL) application

DECISIONS OF THE 27thMEETING OF THE MEDICAL DEVICE BOARD (MDB) HELD ON 21012021 1. APPLICATIONS FOR GRANT OF ESTABLISHMENT LICENSE TO IMPORT MEDICAL DEVICES. S. No1. Name Establishment of Director/Proprietor/ partners/s Pharmacy

How to fill out medical device establishment licence

How to fill out medical device establishment licence

1. Determine if you need a medical device establishment licence by checking Health Canada's guidelines.
2. Fill out the application form with accurate information about your establishment.
3. Provide all required documentation, such as proof of Good Manufacturing Practices (GMP) compliance and Quality Management System (QMS) certification.
4. Submit the application along with the required fee to Health Canada for review.
5. Wait for Health Canada to process your application and issue the medical device establishment licence.

Who needs medical device establishment licence?

1. Manufacturers of medical devices
2. Importers of medical devices
3. Distributors of medical devices
4. Packagers and labellers of medical devices
5. Anyone involved in the sale or distribution of medical devices in Canada

For pdfFiller’s FAQs

How do I complete medical device establishment licence online?

pdfFiller makes it easy to finish and sign medical device establishment licence online. It lets you make changes to original PDF content, highlight, black out, erase, and write text anywhere on a page, legally eSign your form, and more, all from one place. Create a free account and use the web to keep track of professional documents.

How do I make changes in medical device establishment licence?

With pdfFiller, it's easy to make changes. Open your medical device establishment licence in the editor, which is very easy to use and understand. When you go there, you'll be able to black out and change text, write and erase, add images, draw lines, arrows, and more. You can also add sticky notes and text boxes.

How do I complete medical device establishment licence on an iOS device?

Download and install the pdfFiller iOS app. Then, launch the app and log in or create an account to have access to all of the editing tools of the solution. Upload your medical device establishment licence from your device or cloud storage to open it, or input the document URL. After filling out all of the essential areas in the document and eSigning it (if necessary), you may save it or share it with others.

What is medical device establishment licence?

The medical device establishment licence is a license issued by the regulatory authority that authorizes a company to manufacture, import, or distribute medical devices within a specific jurisdiction.

Who is required to file medical device establishment licence?

Any company involved in the manufacturing, importing, or distributing of medical devices is required to file for a medical device establishment licence.

How to fill out medical device establishment licence?

The medical device establishment licence application can typically be filled out online or in paper format provided by the regulatory authority. The application will require information about the company and the types of medical devices being handled.

What is the purpose of medical device establishment licence?

The purpose of the medical device establishment licence is to ensure that medical devices being manufactured, imported, or distributed meet regulatory standards for safety and effectiveness.

What information must be reported on medical device establishment licence?

The medical device establishment licence application typically requires information about the company name, address, types of medical devices being handled, and quality management processes.