China medical device registration electronic certificates will be issued from November 1, 2022, and will have the same legal effect as the paper version of the registration certificate. The National Medical Products Administration (NMPA) announced the full implementation of electronic certificates for medical device registrations on October 26, 2022, and addressed the implementation details accordingly.
Main points
- Electronic medical device certificates also mean that applicants can receive real-time reminders by SMS to verify the authenticity of the electronic license by scanning the code, and querying the latest status of the electronic license
- The electronic registration certificate not only saves printing, copying, and mailing but it also reduces the timeline to obtaining the certificate.
- The overseas applicant can obtain China medical device registration electronic certificates through their NMPA legal agent’s account. Companies can also log on to the “China Drug Administration App” to view the use of electronic registration certificate.
- Medical device electronic registration certificates do not contain Product Technical Requirements (an integral part of the certificate), instructions and other attachments. These attachments can downloaded as electronic files are available in the My License section of the NMPA account
- Applicants should properly store the National Medical Products Administration (NMPA) online office hall account, electronic registration certificate and related attachments such as electronic documents.
Further information
Click here to read the announcement in full.
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