Medical Device Registration and Approval in Canada

REGULATORY AUTHORITY:

Health Canada

CLASSIFICATION SYSTEM:

Medical Devices/IVDs: I/II/III/IV.

TIMEFRAME:

Class II – 15 calendar days*

Class III – 75 calendar days*

Class IV – 90 calendar days*

*This is target performance standards stipulated by Health Canada to review the submitted dossier. This excludes time needed for administrative screening, regulatory screening, technical screening or additional review in case the manufacturer provides additional information and/or documents.

SPECIAL REQUIREMENT:

Local testing or clinical study is not required.

An establishment license (MDEL) is required for the manufacturers of class I device who do not sell their products through a licenced importer or distributor, to operate in Canada.

LOCAL FEES (New Application):

Medical Device License (MDL) application:

Class II – CAD 522

Class III – CAD 10,679

Class IV – CAD 25,955

LOCAL FEES (Manufacturer):

Medical Device Establishment License (MDEL) application for the manufacturer of class I device: CAD 4,737 or CAD 3,552.75 (for registered small business)

 

LICENSE VALIDITY:

There is no validity for both MDL and MDEL but the license must be renewed annually otherwise it will be cancelled.

LICENSE TRANSFER:

Not applicable.

AUTHORIZED REPRESENTATIVE:

The foreign manufacturer who intends to sell their medical devices in Canada does not need a Local Authorized Representative because the foreign manufacturer can hold their own product marketing authorization.

ADDITIONAL INFORMATION:

Health Canada requires all manufacturers of class II, III, and IV medical devices to have their QMS complied with ISO 13485 under the Medical Device Single Audit Program (MDSAP) before they can apply for MDL.

 

Other North American Countries: Mexico, United States of America