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The Device Examination Center adjusts the delivery method for administrative license documents for certain medical device application matters
Release time:
2025-03-12 09:42
China Food and Drug Administration (CFDA) Jiang HongyuOn August 30, the Center for Medical Device Evaluation (CMDE) of the National Medical Products Administration (NMPA) issued the "Notice on Adjusting the Delivery Method of Administrative License Documents for Certain Medical Device Application Items (No. 12, 2019)". The notice shows that, from the date of issuance of the notice, for online submissions, the CMDE will no longer mail the administrative license documents at the acceptance stage, including: acceptance notice, payment notice, notice of correction of application materials, notice of non-acceptance, change certificate for medical device/in-vitro diagnostic reagent registration items. Applicants or registrants can view the relevant electronic documents online in the above manner. For offline submissions, the delivery method of administrative license documents at the acceptance stage remains unchanged.
According to the State Council's"Internet + Government Services" action requirements, steadily promoting the convenience of medical device review and approval services, and promoting the healthy development of the industry, the NMPA issued the "Announcement on the Implementation of Electronic Submission for Medical Device Registration (No. 46, 2019)" on May 29, 2019. The electronic submission information system for medical device registration (eRPS system) was also officially launched on June 24, 2019. Applicants and registrants of medical devices can conduct online electronic submissions for medical device registration within the Business Scope of the eRPS system. By Signing In with CA to the medical device registration enterprise service platform, they can view the relevant electronic administrative license documents synchronously. The function has been running relatively stably since the launch of the eRPS system two months ago.
According to the "Several Provisions of the State Council on Online Government Services", electronic materials with electronic seals are legally valid and can be used as the basis for handling government service matters. In order to further leverage the advantages of the electronic government platform, the CMDE has decided to adjust the delivery method of administrative license documents for some medical device application items after research.
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