On December 29, 2021, the NMPA (National Medical Products Administration) issued (No.157-2021) the new finalized emergency approval procedures for medical devices with immediate effect to replace the previous version issued in 2009.
Scope
The emergency approval procedures can be applied to domestic class III, imported class II and class III medical devices for either one of the following purposes:
- In response to the needs of public health emergencies whilst no similar products have been marketed in China; or
- In response to the insufficient supply of similar products that have already been marketed in China to handle public health emergency situations.
What’s new
- After the emergency approval and conditional approval are granted, if the conditions listed on the license of registration is completed within the 1 year expiration whilst the requirements for renewal have also been met, the license of registration can be renewed for 5 years.
- Once the application for emergency approval is confirmed accepted by the NMPA, the applicants are required to complete the dossier submission and related requirements within 90 days, otherwise, the application can no longer be applicable for emergency approval.
Innovative and Priority Approval
On December 2, 2021, the CMDE (Center for Medical Device Evaluation) of the NMPA published the revised version of the administrative provision on communication and information exchange for the technical review of innovative and priority approvals.
Once the medical device is confirmed to be an innovative product, the evaluation department and clinical department under the CMDE will arrange the first conference meeting with the applicant, and communicate at least once every year to follow up on the status of the product development prior to the application for registration.
For general technical issues, the applicant can get in touch with the CMDE by phone, email, etc. Otherwise, an application for conference meeting should be submitted by the applicant and approved by the corresponding CMDE department to discuss on major technical or safety problems, clinical trial protocol, summary and evaluation of phased clinical trial results, etc.
For fast track approval related to emergency, innovative, and priority approvals, contact Cisema if you would like to learn more.
By Alice Liu and Jacky Li.
