Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in June 2026. These updates are presented by China Med Device, LLC, your partner in Chinese market access.
Policies
Seven Class III Devices Exempted from Clinical Trial, involving Neurology, Cardio Surgery, Nephrology, Gastroenterology, Dental
NMPA published the “Clinical Evaluation Exempt Catalog for Medical Devices” on May 13, 2025, which newly-includes 27 medical devices, including 7 Class III and 20 Class II devices. In total, 1047 medical devices have been exempted from clinical evaluation.
The following Class III devices are exempted from clinical trial: Intracranial Balloon Dilatation Delivery Catheter, Atrial Septal Puncture Sheath, Dialysis Indwelling Needle, Disposable Sterile Injection Needle, Disposable Sterile Side-Hole Blunt Needle, Disposable Endoscopic Injection Needle, and Preformed Polymer-Based Crown and Bridge Material.
The Class II devices such as Personalized 3D Printed Surgical Models, Ear Endoscope, Spinal Endoscope, Non-Invasive Ambulatory Blood Pressure Monitor are also exempted from clinical trial
Click HERE for our comprehensive analysis on the exempt catalog,
NMPA Officials on Aesthetic Active Devices’ Classification
In recent years, active devices based on laser, ultrasound, and radiofrequency technologies have gained significant popularity in the field of aesthetic medicine due to their remarkable effectiveness and diverse applications. Below article is from the Center of Medical Device Standardization of NMPA. It analyzes, from a technical perspective, the factors that need to be considered in determining the attributes of active beauty devices, taking into account their mechanisms of action, intended use, and risks during use, and provides relevant technical recommendations.
Click HERE for the NMPA article that explains product classification of laser, ultrasound, and radiofrequency technologies.
Guidelines & Standards
55 Class III Devices Impacted by 2025 Guidelines Revisions Plan
NMPA published the “2025 Medical Device Guidelines Revisions Plan” on May 7, 2025, in which 55 guidelines for Class III and 55 for Class II devices are affected.
The plan impacts the Class III devices guidelines such as those of Modeling and Simulation Technology, CT Tube, Drug Infusion Pump, Monitoring Alarm, Cryoablation Therapy Device, Surgical Navigation and Positioning System, etc. Click HERE for our analysis on the release
Featured Article
Advances in the Treatment of Dry Eye Disease: Innovations in Punctal Plug and Gel Therapies
With the increasing use of digital screens, aging populations, and changing environmental conditions, the incidence of Dry eye disease (DED) continues to rise globally. While traditional treatments such as artificial tears and anti-inflammatory agents offer symptomatic relief, they often suffer from poor patient adherence and long-term safety concerns.
In recent years, punctal occlusion therapies—particularly those utilizing innovative biodegradable materials like polyvinylpyrrolidone (PVP), poly(lactic-co-glycolic acid) (PLGA), and hyaluronic acid (HA)—have emerged as promising alternatives that physically preserve tear volume and improve ocular surface health. Click HERE for the article that explores the science, clinical value, regulatory status, and future directions of these novel therapeutic modalities.
About China Med Device, LLC
China Med Device, LLC (www.ChinaMedDevice.com) provides turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA legal agent with offices in Boston, Beijing and Hainan, we can represent you for product life cycle without your need to create a local entity in China. Our RA services include strategy, registration, type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and PMS. Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.