GREY:EPWCF - Post by User
Post by
red2000on Feb 13, 2021 1:11pm
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Post# 32562040
About MDEL licence...
About MDEL licence... Good job CBDT to make a partnership agreement with MEdipro
It's not easy in Canada, to importe or distribute medical devices
https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/annual-review-documents/frequently-asked-questions-medical-device-establishment-licensing-fees.html
3.
What is a Medical Device Establishment Licence (MDEL)?
A Medical Device Establishment Licence (MDEL) is issued for the activities of importing or distributing (selling) medical devices for human use in Canada. An MDEL is issued by Health Canada's Regulatory Operations and Enforcement Branch (ROEB), based on an attestation that the establishment meets all of Health Canada's MDEL regulatory requirements.
During an inspection by Health Canada, MDEL holders must demonstrate to Health Canada that they meet the regulatory requirements they attested to having in place (e.g. documented procedures in place) related to the medical devices that they import or distribute (sell) in Canada.
Guidance on Medical Device Establishment Licensing (GUI-0016) provides a definition for "distributor", "importer" and "sell".
- Distributor
- A person, other than a manufacturer, an importer or a retailer, who sells a medical device in Canada for the purpose of resale or use, other than for personal use. A person outside of Canada selling medical devices into Canada is also considered to be a distributor.
- Importer
- A person in Canada, other than the manufacturer of a medical device, who is responsible for the medical device being brought into Canada for sale.
- Sell
- As defined in section 2 of the Food and Drugs Act - Includes:
- offer for sale, expose for sale or have in possession for sale, or distribute to one or more persons, whether or not the distribution is made for consideration; and
- lease, offer for lease, expose for lease or have in possession for lease.
4. 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.