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"Decision on Adjusting Some Medical Device Administrative Examination Approval Procedures" interpretation
Release time: 2017-04-06 & nbsp & nbsp & nbsp Source: Anonymous

 

Recently,The State Administration of Food and Drug Administration announced the "Decision on Adjusting the Approval stake sports betting appProcedure Stake Sports Bettingof Administrative Approval Matters of Medical Device",Decision of the clinical trial approval of the third type of high -risk medical device、Domestic third category of medical devices and imported medical device licenses change approval decision、Domestic third categories of medical devices and imported medical devices continuing to register for registration approval,Adjustment to the reason for the medical device technology review center of the State Food and Drug Administration to make it in the name of the State Food and Drug Administration。Starting from July 1, 2017。

2014,Food and Drug Administration actively implements the newly revised "Regulations on the Supervision and Administration of Medical Device",Released the "Measures for Registration of Medical Device", "Administrative Measures for the Registration of End Diagnostic Reagents", "stake online sports bettingMy stake betting appthe third category and Imported Medical Device Registration Approval Operation Specifications" and other documents,Clarifying the third category and imported medical device registration approval includes acceptance、Technical review、Four links Stake Sports Bettingof Administrative Approval and approval production,Among them, the technical review is responsible for the medical device technology review center of the General Administration,Administrative approval is responsible for the General Administration。After the review of medical device technology is over,The General Administration of Food and Drug Administration will make an approval decision within 20 working days from the date of receiving the technical review opinion。

The decision of the technical review and administrative approval decision of some approval matters will be issued by the General Administration of Medical Device Technology Review Center,For the adjusted approval items,Working procedures include acceptance、Technical review and administrative approval、Batch production three links,Optimized the approval process。For the adjusted stake sports betting appapproval stake sports betting appitems,After the General Administration of Medical Device Technology Review Center issued an approval decision,The corresponding department of the General Administration produces "Medical Device Registration Certificate", "Registration of Medical Device Registration" within 10 working days.。

Adjustment of the approval procedures for the administrative approval of some medical equipment,It is an important measure for the General Administration to implement the spirit of reform and approval system for the review and approval of the medical device,Integrated technical review and administrative approval resources,Improved work efficiency,Improved work efficiency。