Medical devices subject to priority approval include:
Situation (1): medical devices that diagnose or treat rare diseases and malignant tumors and have obvious clinical advantages; medical devices that diagnose or treat frequently-occurring diseases endemic to the aged (no effective diagnostic or therapeutic means is currently available); medical devices specially designed for children and having obvious clinical advantages; medical devices that are urgent for clinical use with no similar products approved in China;
Situation (2): medical devices included in National Science and Technology Major Project or National Key R&D Program of China.
As there may be other situations where medical devices needed to be approved at high priority, the term “other medical devices subject to priority approval” is established herein. For other medical devices subject to priority approval, NMPA shall organize experts to examine the actual situation and determine whether to give priority based on opinions from all sides.
Official Administrative Charges:
NMPA does not charge for innovative medical device application. Whether the application for innovative medical devices is approved or not, the official administrative charges for the initial registration of the medical device (Class II/III) will not be affected. The fees payable can be reduced or exempted in the case of the initial registration of innovative medical device involving a manufacturer who is a micro- or small-sized enterprise.
Situation (1): A total of 43 working days, officially entering the priority approval channel (queuing separately).
Situation (2): A total of 28 working days, officially entering the priority approval channel (queuing separately).
If on objection has been raised, the medical device involved can officially enter the priority approval channel (queuing separately) within 18 working days at the soonest.
As for the registration applications of medical devices subject to priority approval, the CMDE (Center for Medical Device Evaluation) of NMPA will arrange the order separately by the time of receipt, and give priority to the technical review of these applications.
The Medical Products Administration authority at the provincial level will give priority to the QMS audit of these medical devices subject to priority approval during technical review.
Initial Registration of Imported Class III MD
Registration Renewal of Imported Class III MD
Initial Registration of Imported Class II MD
Registration Renewal of Imported Class II MD
Application for Innovative Medical Device (Imported)
Initial Registration of Imported Class III IVD
Registration Renewal of Imported Class III IVD
Initial Registration of Imported Class II IVD
Registration Renewal of Imported Class II IVD
Application for Innovative Medical Device (Imported)
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