Register for Upcoming Webinar on DEC. 8 @ 11AM
2026 China NMPA Bluebook is here:
NMPA released the final guideline “Clinical Trial Key Points on Implanted Brain-Computer Interface (BCI) Hand-Movement Compensation Systems” on October 22, 2026. The draft version was issued in July 2026 for
NMPA published the “Clinical Evaluation Exempt Draft Catalog for Medical Devices” and “Clinical Evaluation Exempt Draft Catalog for In Vitro Diagnostics” on April 30, 2026. Feedbacks need to be submitted
NMPA published 5 medical devices final guidelines on April 30, 2026. They are aimed to facilitate manufacturers with clarity in clinical evaluation requirements. All five guidance documents are directed at
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 Medical Devices Catalog” on September
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 of Guangdong province: Guangzhou, Shenzhen,
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 registration dossiers and clinical evaluation
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 type testing or significant burden
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 Class III IVDs. The draft
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 Class II devices. Implementing risk-based
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 27, 2024. Feedback needs to
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 submitted by December 3, 2024.
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 Instruments, Radiotherapy Devices, Diagnostic Devices,