Imported Active Medical Device Includes A Variety Of Configurations When Marketed In Original Country, But Only Part Of The Configurations Was Selected When Submitted In China. Will It Be Accepted?
2022-09-20
When imported medical devices is submitted registration in China, the scope of application of the medical device shall not exceed the scope when approved in the original country. If only part of the configuration is submitted, and the submitted part can be applied independently and the manufacture ensures its safety and effectiveness, manufactures can make reductions on the basis of the approved scope of original country.
