Canada being an IMDRF founding member has a harmonized regulations in place governed by Health Canada. The Canadian requirement for the license depends on the classification of the medical device. Canada is the only country mandating the MDSAP for QMS compliance and don’t need an in-country representative for medical device licensing process.

Canada is the eighth largest medical device market. Substitution of expensive products, rising prices of products and more per patient use of medical supplies contribute to the industry’s growth. The Canadian medical device market is sophisticated and mature, with pertinent demand for high quality medical device technologies.

Classification

Determination of the medical device classification is the first and foremost step for the medical device manufacturers. Doing it right is very important. The class to which your device is assigned determines, among other things, the conformity assessment pathway required and the PMS requirements.

MDL

A Medical Device Licence (MDL) is a licence issued to Class II, III and IV medical device manufacturers as well as importers to permit them to import or distribute a medical device in Canada.

MDEL

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.

An MDEL provides Health Canada assurance that medical devices sold or imported into Canada meet the safety requirements set out in the Medical Devices Regulations, and those procedures are in place to protect the public should a problem with a device be identified.