CMDE solicits public comments on three guidelines

On June 17, 2026, China's National Medical Products Administration Center for Medical Device Evaluation (CMDE) issued a public notice soliciting comments on three draft guiding principles for medical device registration review. Among these, the "Guiding Principle for Clinical Evaluation Registration Review of AI-Assisted Diagnosis Medical Devices (Draft)" stands out as a landmark document that will shape the regulatory pathway for one of the fastest-growing segments in China's medical device landscape.

The Three Draft Guiding Principles

1. AI-Assisted Diagnosis Medical Device Clinical Evaluation Registration Review Guiding Principle

This is the most significant of the three drafts, establishing a systematic framework for clinical evaluation of AI-powered diagnostic devices. The principle applies to devices that use AI algorithms to assist in identifying lesions, abnormalities, or diagnostic features in medical images or data — covering the rapidly expanding field of AI-assisted detection, characterization, and classification tools across radiology, pathology, ophthalmology, and other imaging disciplines.

Key aspects include:

Requirements for algorithm performance validation demonstrating accuracy, sensitivity, specificity, and robustness across diverse clinical populations and imaging conditions

Standards for training, validation, and test datasets — including data diversity, representativeness, annotation quality, and size requirements

Clinical study design expectations — whether prospective, retrospective, or hybrid approaches are acceptable

Generalizability requirements — demonstrating that AI performance holds across different scanner models, imaging protocols, patient demographics, and clinical settings

Human-AI interaction evaluation — assessing how clinicians interact with AI outputs and whether the tool genuinely improves diagnostic performance versus creating over-reliance or dismissal patterns

2. Orthopedic Joint Replacement Navigation System Same-Product Clinical Evaluation Guiding Principle

This document provides detailed guidance for manufacturers seeking to use the same-product (equivalent device) clinical evaluation pathway for orthopedic joint replacement navigation systems — a significant procedural tool in the orthopedic surgery space. It clarifies what constitutes an appropriate predicate device, what clinical data must be demonstrated for equivalence, and how to structure the clinical evaluation report.

3. Diabetic Retinopathy AI-Assisted Diagnosis Software Clinical Trial Guiding Principle

Focused specifically on diabetic retinopathy screening software — one of the most mature and widely deployed AI medical device applications in China — this draft provides detailed requirements for clinical trial design, endpoint definition, sample size calculation, and performance benchmarking. Given that multiple DR screening products have already obtained NMPA approval, this guiding principle will both codify existing practice expectations and set higher standards for next-generation products.

Consultation Timeline and Process

Public comments are being accepted through July 10, 2026. All stakeholders — including manufacturers, clinical institutions, regulatory professionals, and academic researchers — are encouraged to review the drafts and submit feedback. The three guiding principles are available on CMDE's official website.