Medical Device Accessories - Health Canada - CMDR Section 21

[meenakshi2017]

Hi Guys,

Do Accessories needs to meet Health Canada - CMDR Section 21 Requirements?

any guidance is highly appreciated

Thanks
Meenakshi

 

[shimonv]

Hi Meenakshi,
Generally speaking - yes. In essence, an accessory is not much different than a finished devices except that it is intended to support, supplement, and/or augment the performance of one or more parent devices. The requirements from an accessory depends on its characteristics and the classification of the parent device.

Best,
Shimon