Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros. These updates are presented by China Med Device, LLC, your partner in Chinese market access.
Policies
NMPA Issues More Detailed Rules for Innovative Medical Devices
NMPA published the “Implementation Rules for the Special Review of Innovative Medical Devices” on April 18, 2025. The document is based on the Innovative Medical Devices Review Procedures released in 2018.
The document describes the expert review system that innovation applications adopt, with experts randomly and blindly selected. It also explicates the eligibility criteria, application submission, final review and public notification process and appeals and communication.
Click HERE for our comprehensive review on the new policy, with key considerations including the patent localization, Chinese language requirements, regulatory agent representation, clinical trial expectations, etc.
NMPA’s Dual-Track Review Framework: New Guidance for Priority Device
NMPA published the “Implementation Rules for the Priority Approval Review of Medical Devices” on April 18, 2025. The document describes the eligibility for priority review. It also establishes two paths for priority review: Expert Review Path for devices treating rare diseases, cancers, elderly/children-specific diseases, or urgently needed products with no domestic equivalent; and Internal Review Path for devices included in major national science or R&D programs. Click HERE for more information
Guidelines & Standards
NMPA Issues Seven Guidelines for IVDs
NMPA published the seven IVD reagents guidelines on March 31, 2025. They are aimed to facilitate manufacturers with more product-specific guidance and clarity in registration process:
- Guideline on Stability Study of In Vitro Diagnostic Reagents
- Guideline on ALDH2 Gene Polymorphism Detection Reagents
- Guideline on Human MTHFR Gene Polymorphism Detection Reagents
- Guideline on Estrogen Receptor and Progesterone Receptor Antibody Reagents and Detection Kits
- Guideline on Fully Automated Chemiluminescence Immunoassay Analyzer
- Guideline on Hepatitis B Virus Genotyping Detection Reagents
- Guideline on Hepatitis C Virus RNA Detection Reagents
Click HERE for our analysis on the release
Featured Article
Global Trends and Market Opportunities for Additive Manufacturing in Orthopedics: A Strategic Reference for Entering China
Additive Manufacturing, or 3D printing, is now widely applied in orthopedic implants, surgical guides, bone tissue engineering scaffolds, and more. It enables personalized design and precise manufacturing of implants based on CT or MRI data, significantly improving fit and postoperative recovery. Moreover, 3D printing supports the rapid prototyping of complex structures, shortening product development cycles and enhancing R&D efficiency.
Click HERE to read the article that systematically explores its current applications in orthopedics, leading foreign enterprises, indications, and development trends, aiming to provide strategic insights for overseas Additive Manufacturing companies entering the Chinese market.
