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Medical Device Accessories - Health Canada - CMDR Section 21

M

meenakshi2017

#1
Hi Guys,

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

any guidance is highly appreciated

Thanks
Meenakshi
 
Elsmar Forum Sponsor

shimonv

Trusted Information Resource
#2
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
 
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