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Administrative Measures for Medical Device Registration and other four Administrative Measures issued
- Publisher：
- Publication：2014/8/29
The newly revised Regulations for the Supervision and Administration of Medical Devices was put into force on June 1, 2014. To support the implementation of the Regulations, China Food and Drug Administration (CFDA) formulated and revised Administrative Measures for Medical Device Registration, Administrative Measures for the Registration of In Vitro Diagnostic Reagents, Administrative Rules for the Instructions and Labels of Medical Devices, Administrative Measures for the Supervision of Medical Device Manufacturing, and Administrative Measures for the Supervision of distribution of Medical Devices. These five Administrative Measures have been adopted at the executive meeting of CFDA on June 27, 2014, and was promulgated on July 30, 2014 as CFDA Order No. 4, Order No.5, Order No.6, Order No.7 and Order No. 8. These Administrative Measures will go into effect as of October 1, 2014.