MEDTECH NEWS

On June 8, 2026, China's NMPA, jointly with three other national health authorities, issued the revised "Good Clinical Practice for Drug Clinical Trials," effective September 1, 2026, replacing the 2020 version. The update aligns closely with ICH E6(R3), restructuring the GCP into six chapters and adding a new Data Governance chapter to strengthen data reliability and traceability. It sharpens accountability—designating principal investigators as ultimate on-site responsible parties and sponsors as bearing final trial responsibility—while reinforcing participant protections, particularly for vulnerable populations and informed consent.

China's NMPA has announced new guidelines (No. 22 of 2025) for medical device clinical trial inspections, effective May 1, 2025. The rules establish clear criteria for evaluating both pending applications and approved devices, focusing on authenticity and compliance. This update replaces 2016 and 2018 regulations, strengthening clinical trial oversight.

NMPA has approved new measures to enhance the supervision of medical device clinical trial institutions. These measures, effective from October 1, 2024, aim to clarify regulatory responsibilities, standardize inspection procedures, and ensure the protection of trial participants' rights and safety. The initiative emphasizes the importance of trial quality and outcome authenticity. In support, the NMPA will soon release detailed inspection guidelines and conduct training sessions to improve regulatory capabilities.

The National Medical Products Administration (NMPA) is seeking feedback on draft regulations for the supervision and audit of clinical trial institutions for medical devices. These regulations aim to enhance management practices and standardize audit processes. The guidelines, developed in alignment with existing regulations and good clinical practices, outline 16 audit sections and 96 items, covering institution and clinical trial profession aspects. Defects are classified as severe, major, or general, with conclusions drawn based on the severity of non-compliance.

A landmark clinical trial for an innovative medical device has shown significant weight loss in subjects, underscoring a commitment to advancing non-surgical obesity treatments and medical technology innovation.

TX Medical News emphasizes the critical need for careful, evidence-based selection of single-arm clinical trial designs in medical device innovation, ensuring safety and efficacy while addressing the unique challenges of groundbreaking technologies.

The NMPA CMDE are advancing medical device innovation with reforms focusing on single-arm study designs to enhance clinical evaluations, ensuring devices meet the highest standards of safety and efficacy for end-users.

The "Guidance on Real-World Study Design and Statistical Analysis for Medical Device Registration Review" issued by the NMPA and CMDE on January 10, 2024, revolutionizes the use of real-world data in China's medical device clinical evaluations, enhancing device safety and efficacy assessments in real-life applications.