Register for Upcoming Webinar on DEC. 8 @ 11AM
2026 China NMPA Bluebook is here:
The Guangdong Provincial Medical Products Administration and the Guangdong Provincial Health Commission issued the “Administrative Measures for the GBA Urgently Needed Hong Kong–Macao Drugs and
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
NMPA released the “Clinical Evaluation Guideline for In Vitro Diagnostic Reagents for Cancer Screening” on August 21, 2025. The document provides direction for applicants preparing
Hainan Boao Pilot Zone allows overseas unapproved medical devices, IVDs, drugs, with clinical urgency status to be used in China. It does NOT require local
NMPA published the “Clinical Trial Exempt Catalog for In Vitro Diagnostic Reagents” on June 24, 2025, which exempts 445 IVDs from clinical trials, including 27
NMPA published the “Clinical Evaluation Exempt Catalog for Medical Devices” on May 13, 2025, which newly-includes 27 medical devices, including 7 Class III and 20
NMPA Center for Food and Drug Inspection released the “Key Points for the Inspection of Real-World Studies on Medical Devices (Draft)” for feedback on December
NMPA published the “Clinical Trial Exempt Catalog for In Vitro Diagnostic Reagents (Draft)” on November 5, 2024, which newly-includes 387 IVDs. Feedback needs to be
The NMPA CMDE (Center of Medical Device Evaluation) published the “Clinical Trial Design Types Recommendations for Non-active Implantable Devices, Neurological and Cardiovascular Surgical Devices, Dental
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
NMPA published the “Clinical Evaluation Exempt Catalog for Medical Devices (Draft)” on July 31, 2024, which newly-includes 23 medical devices. Feedback needs to be submitted
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