Canadian regulation gap assessment

[MDRexpert]

Can someone share gap assessment or a template for Canadian regulations with QMS 13485:2016 ?

Thank you!

 

[RA_QA_Expert]

Canada recognizes ISO13485:2016. The main areas that are not specifically covered by ISO are Medical Device Authorization and Facility Registration, Vigilance system, Distribution records and Product Compliance with essential principles.

You can find the answers in MDSAP Companion Document (if you dont have it yet).

 

[burche]

If a Chinese supplier to a Canadian medical device company holds ISO 13485:2016, does that supplier still needs MDSAP or any other certification to prove compliance with CMDR?

 

[RA_QA_Expert]

If a Chinese supplier to a Canadian medical device company holds ISO 13485:2016, does that supplier still needs MDSAP or any other certification to prove compliance with CMDR?

The MDSAP certificate is mandatory for all class II, III and IV medical device menufacturers selling their devices in Canada. Only class I device manufacturers are exepted.

 

[burche]

The MDSAP certificate is mandatory for all class II, III and IV medical device menufacturers selling their devices in Canada. Only class I device manufacturers are exepted.

If the Canadian manufacturer has MDSAP certificate, does the supplier in China also needs it?

 

[DannyK]

If the scope of the Canadian manufacturer MDSAP certificate covers the medical devices that the Canadian company wants to sell, then the Chinese supplier does not require MDSAP.

 

[Edward Reesor]

The seller must have MDSAP and to satisfy that, they need to show vigilance with any foreign based contract manufacturer. Although the manufacturers don't have to be ISO 13485:2016, it certainly helps your certification process if they are. Therefore, if the manufacturer only makes them for another company selling into Canada, only the seller requires the MDSAP. If the manufacturer later decides they want to offer their product into Canada, then they will need a MDSAP.

For example, we demand any foreign based contract manufacturer or supplier to hold a valid ISO 13485:2016 certificate. As a Canadian-based company, we must have MDSAP to sell our products in Canada. Fortunately, the FDA also accepts MDSAP, so it covers both markets.

 

[burche]

The seller must have MDSAP and to satisfy that, they need to show vigilance with any foreign based contract manufacturer. Although the manufacturers don't have to be ISO 13485:2016, it certainly helps your certification process if they are. Therefore, if the manufacturer only makes them for another company selling into Canada, only the seller requires the MDSAP. If the manufacturer later decides they want to offer their product into Canada, then they will need a MDSAP.

For example, we demand any foreign based contract manufacturer or supplier to hold a valid ISO 13485:2016 certificate. As a Canadian-based company, we must have MDSAP to sell our products in Canada. Fortunately, the FDA also accepts MDSAP, so it covers both markets.

Thanks so much, this helped a lot!