Who needs to have the MDEL in Canada?
Who requires a Medical Device Establishment Licence (MDEL)? A Medical Device Establishment Licence (MDEL) is required by Class I manufacturers, as well as importers or distributors of all four device classes to permit importation or distribution (sale) of a medical device in Canada.
What is a drug establishment license Canada?
A Drug Establishment Licence allows the licensee to legally engage in any authorized activities and signifies Good Manufacturing Practice (GMP) compliance. The goal is to verify that the Canadian pharmaceutical market consists of safe, high-quality drugs.
How do I get a medical device approved in Canada?
Documents must be submitted in English or French. For Class I devices, submit MDEL application, prepare mandatory procedures and pay Health Canada fees. For Class II devices, submit MDL application, Fee Form, labeling (IFU), Declaration of Conformity and ISO 13485 (MDSAP) certificate. Pay Health Canada fees.
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 needed to sell medical devices?
All importers / manufacturers / sellers of notified medical devices must obtain a license from the appropriate licensing authority before undertaking any commerce in notified medical devices. A license is issued only after quality checks. The license holder’s business premise is subject to periodic inspection.
How do I get a MDEL license?
- 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 a site license Health Canada?
A site licence gives the licensee the authorization to manufacture, package, label or import natural health products in Canada. These activities must be carried out according to the good manufacturing practices outlined in Part 3 of the Natural Health Products Regulations.
What is medical device establishment licence?
A Medical Device Establishment Licence (MDEL) is a licence issued to Class I manufacturers as well as importers or distributors of all device classes to permit them to import or distribute a medical device in Canada.
Who can sell medical devices in Canada?
What is a Class 1 medical device Canada?
1. Class I: Low risk devices such as wound care and non-surgically invasive devices. 2. Class II: Low-to-medium risk devices including contact lenses and the majority of surgically invasive devices (e.g., surgical gloves, needles, magnetic resonance imaging equipment).