NMPA Notice On The Filing Examination Requirements For Medical Device Registration
2022-10-09
On August 31, NMPA released a notice on the issue of Filing Examination Requirements for Medical Device Registration and other Documents (NMPA Notice No. 40 of 2022). According to the notice, the trial requirements issued with NMPA Notice No.42 of 2019 have been revised and the new requirements will be implemented from the date of release.
This revision involves a wide range of NMPA filing examination work, with 11 new requirements totaling 170 pages issued together with the notice.
For example, according to the newly released Filing Examination Requirement for Medical Device Registration, clinical evaluation will be completed by staff of NMPA’s Clinical and Biostatistics Department, instead of personnel from its Review Department or Clinical and Biostatistics Department as specified in the 2019 trial requirements. Besides, the basic review question has also been changed from “Is it definite that the product can be regulated as medical device?” to “Is it definite that the product can be regulated as medical device or the device-dominant combo product?”
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