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2026 China NMPA Bluebook is here:
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
The NMPA issued the “Guideline on Instructions for Use of In Vitro Diagnostic Reagents (draft)” for feedback. The guideline stipulates drug information such as the
The NMPA issued the “Clinical Pathway Recommendations for Certain Categories of Medical Devices” on July 14, 2022. The document suggests manufacturers how to choose clinical
The NMPA published eighteen industry recommended standards on July 6, 2022 to guide manufacturers for local type testing and regulatory approval: YY/T 0273-2022 Dentistry-Dental amalgam
The NMPA released the “Guideline for Fundamental Principles Compliance of Medical Device Safety and Performance”, elaborating the risk-based approach for medical device registration review. Article
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in June 2022. These updates are presented by China
The NMPA reclassified 27 medical devices and modified intended use for some with an announcement on March 30, 2022. Among them, 16 devices are applied
The NMPA published the draft version of “Clinical Trial Exemptions Catalog for Medical Devices” on July 5, 2022, for feedback. It is an effort to