NMPA published 5 medical devices final guidelines on April 9, 2026. They are aimed to facilitate manufacturers with clarity in type testing, non-clinical and clinical evaluation and regulatory submission.
The guidelines concern the devices below:
- Intravascular Ultrasound Diagnostic Equipment
- Electrosurgical Cutting Endoscopes
- Fluorescence Imaging for Active Medical Devices
- Capsule Endoscope Systems
- Laser Equipment for Urinary System
Why Overseas Manufacturers Should Pay Close Attention
Intravascular ultrasound diagnostic equipment has long been dominated by a few international giants such as Boston Scientific, Philips, and Canon, with high technical barriers and a large import share in the Chinese market. The NMPA’s issuance of this guideline means that the registration requirements for domestic products are aligning with international standards. Foreign manufacturers must assess whether their existing products comply with the new requirements; otherwise, they may face registration renewal or market access obstacles.
The field of capsule endoscope systems was pioneered by Given Imaging (now part of Medtronic) in Israel, followed by active participation from Olympus, IntroMedic, and others, resulting in a highly concentrated global market. Although local Chinese companies (such as Ankon and Jinshan Technology) have formed a competitive presence, foreign brands still maintain technical advantages in image quality and small bowel diagnostics. Capsule endoscopes are Class III high-risk medical devices involving complex technologies such as wireless communication and image algorithms. The guideline will significantly impact the registration application pathway, making it essential for foreign manufacturers to pay close attention in order to maintain market share.
Laser equipment for the urinary system (e.g., holmium laser, thulium laser) will also receive high attention from companies such as Lumenis, Boston Scientific, etc.
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, and seasoned clinical and regulatory staff to help you shorten your renewal or new approval time. info@ChinaMedDevice.com