China rolls out secure mechanism for medical device review

In an effort to bolster the confidentiality of submissions to its medical device review process, the Chinese government in January 2019 put in place a document registration system applicants may use while seeking approval for their products.

The system being implemented by China’s National Medical Products Administration (NMPA) is entirely voluntary, but authorities say it promises to make it easier for medical device manufacturers to file the technical materials needed to gain market approval from the Chinese government without concern that sensitive information could be seen by competitors.

Under the system, applicants would file their submissions in Device Master Files, or DMFs. Using both hard copies of submissions and the online filing system, applicants will be able to share technical information with NMPA reviewers in a more confidential manner. All DMF materials must be signed and translated into Chinese.