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NMPA Issued 27 Medical Device Industry Standards (Covering YY 0096-2019 Co-60 Teletherapy Unit) and 1 Amendment Form
2019-05-31
After review and approval, NMPA published the YY 0096-2019 Co-60 Teletherapy Unit and other 26 medical device industry standards, as well as the No. 1 amendment form for YY 0285.3- 2017 Intravascular catheters—Sterile and single-use catheters—Part 3: Central venous catheters medical device industry standard.
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NMPA issued the Announcement on Implementing Electronic Application of Medical Device Registration
2019-05-31
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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NMPA issued the Announcement on Adjusting the Relevant Matters Concerning the Definition of the Attributes of Drug/Device Combination Products
2019-05-31
NMPA issued the Announcement on Adjusting the Relevant Matters Concerning the Definition of the Attributes of Drug/Device Combination Products.
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CDE Released the List of the Second Batch of Overseas New Drugs Urgently Needed in Clinical Settings
2019-05-29
On May 29, 2019, NMPA Center for Drug Evaluation issued the Notice on the Issuance of the List of the Second Batch of Overseas New Drugs Urgently Needed in Clinical Setting.
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NMPA Issued the Announcement on Issues Concerning the Import of Reference Drugs for Clinical Research of Biosimilar Drugs
2019-05-28
NMPA issued the Announcement on Issues Pertaining to the One-off Import of Reference Drugs for Biologicals in Clinical Trials (Announcement No. 94 of 2018) on November 30, 2018.
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NMPA Issued 3 Guidelines for Technical Review of the Registration of Synthetic Resin Teeth and Others
2019-05-22
NMPA organized the formulation of and published the three Guidelines on May 22, 2019.
