Home               Contact Us                  Links                     Disclaimer  

Search:

 

SUBSCRIBE (always Free)

  • To our Medical Device news subscription

  • Article Notification (every time a new one is added)

  • Newsletter

Subscribe

 

 

   


 

Does the Canadian TPD work in identical ways to the FDA?

 

 
   

 

 

 

They do in as much as conducting pre-market review, post-approval surveillance and quality systems in the manufacturing process.

However, their processes are very unique and rely on other methods for approval. For instance the TPD do not require a substantial submission file for class II devices (in comparison to the FDA’s requirements for a 510k) but do require compliance to the Canadian Medical Devices Conformity Assessment System (CMDCAS) Under Section 32(2)(f) of the Medical Devices Regulations, manufacturers of Class II medical devices must attest that the quality system under which their devices are manufactured satisfies the quality system requirement ISO/IEC 13488.

Class III and IV

Under Sections 32(3)(j) and 32(4)(p) of the Medical Devices Regulations, manufacturers of Class III and IV medical devices must attest that the quality system under which their devices are designed and manufactured, satisfies the quality system requirement ISO 13485.

 

   
  © Medical Device School 2005