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2026 China NMPA Bluebook is here:
The NMPA published the 27 registration review guidelines on September 15, 2022, which involve a wide range of indications, from chemistry, hematology to dental and
The NMPA released eleven filing review guidelines on September 1, 2022. Equivalent to FDA’s Acceptance and Filing Reviews, it is intended to be used by
The NMPA issued the “Announcement on the transformation of 92 mandatory industry standards and research projects for medical devices into recommended industry standards and research
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in August 2022. These updates are presented by China
The NMPA released the draft version of “Registration Guideline for Radio Frequency Aesthetic Devices” on August 26. 2022 for feedback. Opinions need to be submitted
The NMPA published eighteen industry standards on August 22, 2022, to guide manufacturers for local type testing and regulatory approval: YY/T 0325-2022 Disposable sterile urinary
The NMPA issued Q&A for 34 common issues aroused in medical device type testing and registration. Full List of NMPA common issues If you have
The Greater Bay Area (GBA) – with a total population of approximately 71.2 million people (5% of China’s total population) – includes nine mega cities
The NMPA published ten draft guidelines for IVDs on June 23, 2022, for feedback. They are proposed to direct manufacturers for local type testing and
The NMPA released the list of manufacturers with master files submitted on August 8, 2022. Many overseas companies are on the list. It includes but
Here are the latest China NMPA Regulatory and Clinical Affairs news for medical device and IVDs pros for July 2022. These updates are presented by
The NMPA granted Innovation Approvals to the following devices in July 2022: Cardiovascular Transcatheter prosthetic pulmonary valve system Implantable left ventricular assist system Radiology Gamma