Medical Device Regulatory 101

See also our entire regulatory consulting services and medical device registration services .

If you sell medical devices in Canada, you'll probably need a license to do so. Health Canada (the Food and Drug Administration in Canada) are two types of licenses.

Health Canada Medical Device Establishment License (MDEL, operating license for medical devices)

Manufacturers of medical devices in Class I and in-vitro diagnostics have a Medical Device Establishment License (MDEL) apply if they wish to market directly and not through a Vetriebshändler their products in Canada. If you sell your products through distributors in Canada, they must have a MDEL. Distributors and importers of medical devices and in vitro diagnostic medical need, regardless of the product classification have a MDEL.

NOTE: For manufacturers of medical devices of classes II, III and IV and of IVD no MDEL is required.

Request More Information about Canada and MDL MDEL from Emergo Group

Health Canada Medical Device License (MDL)

Manufacturers of Class II, III and IV shall have in Canada, a Canadian medical device license (MDL). The MDL is a product-specific permission and should not be confused with the MDEL. The MDEL is a permit for the company or the distributor or importer. The Canadian Medical Device License (MDL) is comparable to the U.S. FDA 510 (k) process. The MDL procedure will be faster than the FDA method generally for Class II, about the same rate for Class III and IV runs complicated for Class

If you ask a Canadian medical device license application, you must also prove that you have implemented a certified ISO 13485:2003 quality system that ALSO meets the specific requirements of the Canadian Medical Device Regulations (Canadian Medical Device Regulations, CMDR). Emergo Group can give you in the implementation of ISO 13485:2003 or in modifying your existing system to meet the Canadian requirements , called the Canadian Medical Devices Conformity Assessment System (Canadian Medical Devices Conformity Assessment System, CMDCAS) help.

Emergo Group to the Health Canada MDL and (where appropriate) MDEL application for you submit, so you can introduce your products to the Canadian market. We can assist you in the following ways:

  • Determine the classification of your product in Canada, if it is unclear.
  • Determining the correct annual fee to Health Canada.
  • Preparation and submission of an application for a Canadian Medical Device License (MDL) or a Medical Device Establishment Licence (MDEL).
  • Implementing or upgrading your ISO 13485:2003 Quality Management System to meet the Canadian Medical Device Regulations (CMDR).
  • Staff on-site training on ISO 13485:2003 and the CMDR.
  • On-site audits for compliance with the ISO 13485:2003 and CMDR.

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2006-02-20 17:02:02 by Bioseeker

8 years in biotech

I've been working consistently in the biotech field, after a BA in Psychobiology for 8 years.
-Regulatory Affairs deals with getting FDA approval of new drugs and medical devices.
I went to the Biospace job fair last month but haven't got any calls. I'm wondering if its b/c I currently reside in LA. I'm thinking of moving down there and looking for something fast thru a temp agency. Any advice?

2009-01-11 15:13:59 by windshadow

More from hsi

Last month, a group of FDA scientists sent an SOS to Representative John D. Dingell, chairman of the House Committee on Energy and Commerce. The letter calls for "urgent intervention" due to "serious misconduct" by managers of the Center for Devices and Radiological Health (CDRH) – the FDA division that oversees everything from imaging equipment to breast implants.
So what constitutes "serious misconduct"?
Here's how the scientists put it: "There is extensive documentary evidence that managers at CDRH have corrupted and interfered with the scientific review of medical devices

2007-09-08 13:08:25 by -------

Chip implants shown to cause cancer, a

-
"When the U.S. Food and Drug Administration approved implanting microchips in humans, the manufacturer said it would save lives, letting doctors scan the tiny transponders to access patients' medical records almost instantly. The FDA found "reasonable assurance" the device was safe, and a sub-agency even called it one of 2005's top "innovative technologies."
But neither the company nor the regulators publicly mentioned this: A series of veterinary and toxicology studies, dating to the mid-1990s, stated that chip implants had "induced" malignant tumors in some lab mice and rats

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