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Provisions for Medical Device Registration (Abolished)
2019-07-25
The Provisions for Medical Device Registration, adopted at the executive meeting of China Food and Drug Administration on June 27, 2014, is hereby promulgated and shall be effective as of October 1, 2014.
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NMPA issued the Announcement on Adjusting the Relevant Matters Concerning the Definition of the Attributes of Drug/Device Combination Products
2019-07-06
To further standardize the definition of the attributes of Drug/Device Combination Products, according to the Three- Determinations (of posts, duties and staffing) regulations for NMPA institutions, on May 31, 2019, NMPA announced the relevant matters as follows.
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NMPA issued the Announcement on Implementing Electronic Application of Medical Device Registration
2019-07-06
NMPA has organized the development of the electronic Regulated Product Submission (eRPS) system, and announced the relevant issues on May 31, 2019
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2018 Annual Report for Medical Device Registration Released
2019-07-06
On May 31, 2019, NMPA issued the 2018 Annual Report for Medical Device Registration, which consists of five parts, namely, the situation of medical device registration; the acceptance of medical device registration applications; review and approval of medical device registration; review and approval of registration for innovative medical devices and other products; and management of other registration affairs.
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NMPA Issued 27 Medical Device Industry Standards (Covering YY 0096-2019 Co-60 Teletherapy Unit) and 1 Amendment Form
2019-07-06
After review and approval, NMPA published the YY0096-2019 Co-60 Teletheraphy Unit and other 26 medical device industry standards, as well as the No.1 amendment form for YY0285.3-2017 Intravascular catheters-Sterile and single-use catheters-Part 3:Central venous catheters medical device industry standard on May 31, 2019.
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NMPA Issued 3 Guidelines for Technical Review of the Registration of Synthetic Resin Teeth and Others
2019-07-06
To strengthen the supervision and guidance over the registration of medical device products and further improve the quality of registration review, NMPA organized the formulation of and published the Guidelines for Technical Review of the Registration of Synthetic Resin Teeth,the Guidelines for Technical Review of the Registration of IUD, and the Guidelines for Technical Review of the Registration of Implantable Drug Delivery System on May 22, 2019.
