Policies
NMPA Seeks Feedback on Real-World Study Inspection Guideline
NMPA released the “Key Points for the Inspection of Real-World Studies on Medical Devices (Draft)” for feedback on December 27, 2024. It applies to on-site inspections of retrospective real-world studies conducted by the NMPA Center for Food and Drug Inspection, as part of medical device registration applications.
The guideline aims to ensure the integrity, accuracy, and traceability of real-world studies while upholding strict compliance with regulatory requirements. For our comprehensive review on the guideline, please click HERE
NMPA Reviewers on Quantitative Tumor Marker Testing Reagents
Quantitative tumor marker testing reagents encompass a wide variety of products with numerous applications. The revised Guideline on Quantitative Tumor Marker Testing Reagents serves as the primary technical reference for evaluating these products. This article, published by NMPA Center of Medical Device Evaluation, elaborates on common areas of focus during technical evaluations, integrating the requirements from the guidelines with real-world examples from registration documentation. For more information on the article, click HERE
Fast-Track Approvals
Review Report Released for Mevion Medical’s Proton Therapy System
The NMPA granted innovation approval to Mevion Medical System’s proton therapy system and issued a review report on December 4, 2025.
This product is intended to deliver proton beams for radiotherapy and is suitable for treating malignant solid tumors throughout the body as well as certain benign conditions. Specific indications should be determined by the clinician based on the actual circumstances.
The review report has four sections: product overview, pre-clinical, clinical and risk-benefit analysis. For the outline of the report, please click HERE
Featured Article
DRG (Diagnosis-Related Group) and DIP (Diagnosis-Intervention Packet) have been introduced since 2021 as payment models implemented by the Chinese healthcare system, aiming to standardize and control hospital expenses. The central role of DRG and DIP, mainly carried out by National Healthcare Security Administration (NHSA), is promoting DRG/DIP reforms to optimize resource allocation, cost management, and healthcare quality. Click HERE to read our analysis on the effects of DRG/DIP from procurement and usage trends in hospitals and the response strategies among medical device companies.