NMPA published seven medical devices draft guidelines on November 11, 2025. They are aimed to facilitate manufacturers with clarity in registration process.
Significance of Device Guidelines
The guidelines are prepared by NMPA Center of Medical Device Evaluation (CMDE). They are not legally binding but are highly recommended by regulatory authorities.
For both renewals and new registrations, medical devices need to meet these new guidelines. Even if renewals (required every 5 years by NMPA) have no changes, manufacturers still have to prove that the originally approved products can meet the new guidelines. As a result, approved products still need to go through local type testing to show that they are current with these new requirements.
China Med Device, LLC has test engineers at NMPA testing centers to help you assess and expedite your type testing needs and shorten your renewal or new approval time.
Full List
The release of such a large number of draft guidelines by the China NMPA within a single day is highly meaningful. It signals an accelerated effort by the authority to modernize China’s medical device regulatory framework. By simultaneously issuing guidance documents across diverse product categories—from imaging components and minimally invasive surgical systems to ECMO and urological lasers—NMPA is clearly prioritizing alignment with international regulatory expectations, particularly in areas requiring high clinical and engineering rigor.
For English version of any draft guidelines below, please email info@ChinaMedDevice.com. We charge nominal fees for the translation. We will also give you the email and phone number of contact person that NMPA assigned for the guideline.
The guidelines concern the aspects of devices below:
Cardiovascular & Emergency Medicine
- Clinical Trials of Wearable External Automated Defibrillation Devices
- Clinical Trials of Inferior Vena Cava (IVC) Filters
Radiology
- Reliability Evaluation of Tube Assemblies for X-ray Computed Tomography Equipment
Respiratory
- Decision Pathway for Clinical Evaluation of Extracorporeal Membrane Oxygenation (ECMO) Systems
Gastroenterology
- Registration Submission for Capsule Endoscopy Devices
- Registration Submission for Laparoscopic Surgical Systems – Part 5: Patient Model Testing Studies
Urology
- Registration Submission for Urological Laser Treatment Devices