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  • July 26, 2022
  • WTO

RUSSIA | Draft amendments to the Rules of classification of medical devices depending on the potential risk of use; (39 page(s), in Russian)


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The Draft amendments to the Rules of classification of medical devices depending on the potential risk of use apply to medical devices and provide for the following:clarification of the concepts; clarification of classification criteria for medical devices  for  in  vitro  diagnostics;  establishment  of  criteria  and  conditions  for  the classification of software that is a medical device; clarification of classification of medical devices

Related documents:

- G/TBT/N/RUS/135  

                   

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