06/01/2026
PSA
Our phone has been ringing off the wall today and my phone is blowing up with texts about U-Tools ( I've never heard of them ) and was asked by some nurses, if I would look into them and post my findings. It was great, they hung up on me lol.
U-Tools is a beauty supplier that sells nippers and burs etc... So I called there. They don't have an MDEL ( Medical Device Establishment License ) and have no idea what an MDEL is. Once I explained what it was, she said they don't need it. ( Yes they do ). She also has no idea what a MIFU is. I explained what that was, and she basically just said they are a high grade stainless steel, that was all that I needed to know... So, no, they don't have MIFU's for the instruments that they sell.
Sorry, if the nippers and burs are that cheap, they are not a high grade stainless steel. There are different grades of stainless steel.
Am I telling you not to purchase from them, I wouldn't do that... but my job is to educate you - so here it is, from Health Canada.
1. If you are a medical professional, you should be purchasing from a supplier that holds an active MDEL - here is the link to the Health Canada website - just type in the company name - https://health-products.canada.ca/mdel-leim/index-eng.jsp
2. MDEL is required for anyone/company that sells/distributes medical devices from class 1 to class 4.
3. Valid MDEL holders are required to have labelling and regulatory procedures - compalint labelling, distribution records, procedural and recall documents are kept up to date.
4. IPAC (Infection Prevention and Control) guidance often emphasizes the importance of procuring medical equipment from suppliers holding the appropriate Medical Device Establishment Licence (MDEL). This ensures the equipment meets regulatory standards and is safe for use in healthcare settings. MDEL holders are businesses authorized to import, distribute, or manufacture medical devices in Canada.
5. Health Canada's Medical Device Establishment License (MDEL) is crucial for companies importing or distributing medical devices in Canada. MDEL holders are responsible for ensuring the devices they import or sell meet Canadian safety standards. To legally import or distribute medical devices, including those for human use, companies need an MDEL.
