Policies
Clinical Evaluation of AI-Assisted Diagnostic Medical Devices — Draft Guidance Asks Feedback
NMPA released the “Draft Guideline on Clinical Evaluation of AI-Assisted Diagnostic Medical Devices”. It provides recommendations for clinical evaluation of AI-assisted diagnostic medical devices, specifically those classified as Class III (software or embedded software, code 21-04-02) that aid in characterizing lesions (e.g., benign/malignant status) in medical images. It targets products like those assisting in pulmonary nodule, thyroid nodule, breast nodule, or gastrointestinal polyp evaluation.
For our comprehensive review, click HERE
NMPA Draft Clinical Guideline on Cardiac RF Ablation Devices – Implications for Boston Scientific, J&J, and Abbott
The NMPA released the “Draft Guideline on Clinical Evaluation for Cardiac Radiofrequency Ablation Devices” on July 2, 2026 for feedback. The document provides a structured framework for manufacturers to generate clinical evidence for these high-risk Class III devices, while also serving as a reference for technical reviewers. Its significance lies in clarifying when a full clinical trial is required versus when a predicate comparison may be acceptable.
Currently, overseas manufacturers including Boston Scientific, Johnson & Johnson, and Abbott have already registered cardiac radiofrequency ablation systems and catheters with the NMPA.
For more information click HERE
NMPA Sets Classification and Naming Standards for BCI Medical Devices, with Class II Exception for Non‑AI Stroke Rehab
The NMPA issued “Guideline on Product Classification of Brain-Computer Interface (BCI) Medical Devices” and “Guideline on Nomenclature of BCI Medical Devices” on June 30, 2026. These documents apply exclusively to active medical devices that measure neural signals from the central nervous system (CNS) via invasive or non-invasive means, decode them in real time, and enable bidirectional interaction or closed-loop feedback between the patient and external assistive or therapeutic equipment.
For classifications of invasive/implantable vs non‑invasive BCI devices and the rationale, please click HERE
Guidelines & Standards
57 NMPA Guidelines Released in a One Day: Is Your China Registration Strategy Still Current?
NMPA published 57 medical devices final guidelines on July 21, 2026. They provide clarity in type testing, non-clinical and clinical evaluation and regulatory submission.
For the list of devices categorized by FDA indications, and five devices that manufacturers should pay close attention, click HERE
China Med Device, LLC
China Med Device, LLC (www.ChinaMedDevice.com) provides turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA legal agent with offices in Boston, Beijing and Hainan, we can represent you for product life cycle without your need to create a local entity in China. Our RA services include strategy, registration, type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and PMS. Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.