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