The regulations in Canada:
Regulatory Authority: Health Canada, Health Products and Food Branch, Therapeutic Products Directorate, Medical Devices Bureau
Regulation: Medical Devices Regulations (SOR/98-282)
Representative (should be based in country or not): No requirement.
- MDEL: 120 calendar days.
- MDL: Class II: approximately 2 months. Class III and IV: approximately 4-8 months.
Registration fees: MDEL: $4,581
MDL: Depends on the class
Annual fees: $381
Classification: Class I, II, III, IV
- Medical Device License (MDL) – A license issued to manufacturers authorizing them to import or sell their Class II, III or IV medical devices in Canada.
- Medical Device Establishment License (MDEL) – A license 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.
Documents required for registration (notarization or legalization required or not?): Application for a New Medical Device License for a Private Label Medical Device.
Item 1: Name of the Private Label Medical Device
Item 2: Private Label Manufacturer Information
Item 3: Private Label Regulatory Correspondent Information
Item 4: Original Manufacturer Information
Item 5: Information on Medical Device Manufactured by the Original Manufacturer
Item 6: License Application Type
The following represent the device license application “types” a manufacturer may apply for:
A single medical device:
A medical device that is identified by a unique device name, is sold as a distinct packaged entity and does not meet the criteria for a medical device group, a medical device family, a medical device group family, a system, or a test kit. It may be offered in a range of package sizes, and is represented by a unique device name. Examples might include: an acupuncture needle, an aneurysm clip, a larynx prosthesis or dental cement.
A medical device family:
Means a group of medical devices that are made by the same manufacturer, that differ only in shape, colour, flavour or size, that have the same design and manufacturing process and that have the same intended use. Examples might include: intra vascular catheters, insulin syringes, feeding tubes or vascular access grafts.
A medical device group:
Means a medical device comprising a collection of medical devices, such as a procedure pack or tray, that is sold under a single name. Examples might include: a denture repair kit, a declotting tray, a parenteral administration kit or disposable circumcision tray.
A medical device group family:
Means a collection of medical device groups that are made by the same manufacturer, that have the same generic name specifying their intended use, and that differ only in the number and combination of products that comprise each group. Examples might include: IV administration sets, dressing trays, contact lens care kits or irrigation trays.
Means a medical device comprising a number of components or parts intended to be used together to fulfil some or all of the device’s intended functions, and that is sold under a single name and are manufactured by the same manufacturer. Examples might include hip prostheses, knee prostheses or an ultrasonic imaging system.
Means an in vitro diagnostic device that consists of reagents or articles, or any combination of these, and that is intended to be used to conduct a specific test.
For further assistance in ascertaining the appropriate license application type for your product, refer to the Guidance for the Interpretation of Sections 28 to 31: Licence Application Type.
Item 7: Identifier of Private Label Medical Device
Item 8: Attestations
Appendix 1: Template for the Declaration of Compliance with the Medical Devices Regulations
This template must be completed by an authorized senior official of the private label manufacturer in respect of each device licence application. The completed template must be included in the application.
Appendix 2: Template for Letter of Authorization
The private label device license application must include a letter signed by an authorized senior official of the original manufacturer on the original manufacturer letterhead in the format prescribed in Appendix 2.
Class II, III and IV device manufacturer needs to switch to Medical Device Single Audit Program (MDSAP) to obtain the ISO 13485 certificate.
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