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What is licence amendment in Canada for medical device?

Background of licence amendment in Canada

 

Licence amendment is a change registration of existing licence application upon significant change. In this case, former medical device in licence application will be replaced by new changed medical device. The scope of technical documentation of class II, III and IV medical device upon licence amendment and initial application is the same.

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Manufacturer should consider:

  • Health Canada will only accept quality system certificates that have been issued by special third party auditing organizations called Canadian Medical Devices Conformity Assessment System (CMDCAS) recognized registrars. At time of licence amendment a valid MDSAP is essential.

  • The review time by health Canada after submission of TD is same for licence amendment and initial licence application.

  • Certificate number of Medical Device Licence (MDL) after amendment is the same.

 

Another type of licence amendment

 

Licence amendment of class II, III and IV medical device is upon significant change of product. There is another type of licence amendment upon minor changes: Licence Amendment Minor Changes (Faxbacks).

 

There are different forms by health Canada:

  • Changes to the “product” Name of a Device Licence

  • Changes to the Manufacturer's Name and / or Address

  • Additions/deletions of Catalogue Numbers Only

 

Significant change of medical device

 

There is special guidance Guidance for the Interpretation of significant change of a Medical Device.

The main categories of significant changes are:

  • Changes to Manufacturing Processes, Facility or Equipment

  • Changes to the Manufacturing Quality Control Procedures

  • Changes in Design

  • Changes to Software

  • Changes in Materials for non in vitro diagnostic devices (IVDDs)

  • Changes in Materials in in vitro diagnostic devices (IVDDs)

  • Changes to Labelling

Upon Canadian significant change, changes to the Manufacturing Quality Control Procedures are quite unique which are normally not a product change in most markets and max. to be reported in QM renewal.

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Besides new licence application and licence amendment

 

Although the licence of medical device, legal manufacturer of class II, III and IV medical device has to renew each valid licence before November 1st annualy and pay applicable fees.

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Insight of foundation of legislative of medical device in Canada

 

Canada might be only authority who publishes all useful regulations of medical device in one website. As advanced regulatory affairs you should be able to cluster regulation topic and be a smarter intelligencer.

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