NMPA Center for Medical Device Evaluation Seeks Public Comments on 55 Class II Non-Active Medical Device Registration Review Guidelines

On September 1, 2026, the Center for Medical Device Evaluation of the National Medical Products Administration officially released for public comment 55 draft Registration Review Guidelines for Class II non-active medical devices, including the "Guideline on Registration Review of Radioactive Seed Implantation Protective Products (Draft for Comments)."

The 55 guidelines were developed by the CMDE in accordance with the NMPA's medical device registration review guideline project plan and have now been released as draft versions for public consultation.Stakeholders are invited to submit their feedback and suggestions using the designated feedback form to the respective contacts listed for each guideline before the deadline of October 8, 2026.

The 55 draft guidelines cover a broad spectrum of medical device sectors, including radiotherapy devices, medical ultrasound imaging devices, physical therapy devices, orthopedic surgical instruments, ophthalmic implants and accessories, dental auxiliary materials, infusion/nursing/protective devices, clinical laboratory sampling and analytical equipment, and traditional Chinese medicine devices. This extensive scope presents a valuable opportunity for medical device industry professionals, R&D institutions, and healthcare organizations to stay informed about regulatory developments and participate in shaping standards.

The 55 guidelines span the following major categories:

I. Radiotherapy, Imaging and Diagnostic Categories (7 items): Including radioactive seed implantation protective products, gastrointestinal ultrasound imaging powder, electrostatic physiotherapy patch, radiotherapy patient immobilization devices, medical sterile ultrasound coupling pads, seawater nasal irrigation solution, and HbA1c chromatography columns, covering radiotherapy protection, ultrasound diagnostic assistance, physical therapy, and laboratory analysis.

II. Injection, Puncture and Cardiovascular Interventional Categories (8 items): Including puncture needles, dilators, introducer sheaths, connector valves, disposable high-pressure contrast injection extension tubes, pen injectors, biopsy guns, and disposable human peripheral blood collection containers, covering vascular puncture, interventional access establishment, contrast injection, and tissue biopsy.

III. Ophthalmic, Dental and Orthopedic Surgical Instrument Categories (8 items): Including silicone encircling bands, intraocular lens injectors, bands and buccal tubes, pretreatment agents, orthopedic saws, burr heads, vertebroplasty guidance systems, and annulus fibrosus suturing devices, covering ophthalmic implantation, orthodontics, orthopedic cutting, and minimally invasive spinal surgery.

IV. Endoscope and Surgical Access Channel Categories (4 items): Including disposable endoscope tip caps, disposable endoscope sheaths, spinal surgical access channels, and disposable sterile skin roller needles, used for endoscopic assistance and surgical access establishment.

V. Traditional Chinese Medicine Device Categories (4 items): Including intradermal needles, moxibustion therapy devices, acupoint magnetotherapy devices, and disposable acupoint embedding needles, covering traditional Chinese acupuncture, moxibustion, and magnetotherapy.

VI. Infusion, Drainage and Nursing Categories (12 items): Including enteral nutrition devices, enteral nutrition bags, chest drainage devices, extracorporeal drainage and suction tubes, negative pressure drainage devices and components, passive hemostats, passive tourniquets, disposable balloon uterine stents, disposable rectal tubes (anal tubes), rectal manometry catheters, gastric occult blood collection devices, and sample collection devices, covering enteral nutrition, chest drainage, hemostasis, uterine tamponade, and sample collection.

VII. Respiratory, Anesthesia and Oxygen Supply Categories (4 items): Including respiratory circuit accessory devices, anesthetic gas scavengers, oxygen supply devices, and infant phototherapy eye shields, covering respiratory support, anesthetic gas management, and neonatal phototherapy protection.

VIII. Nasal, Oral and Skin Care Categories (5 items): Including anti-allergic nasal gel, nasal lubricant, tongue depressors, medical pads, and surgical nonwoven dressings, used for nasal care, oral examination, and medical wound dressings.

IX. Other Auxiliary Device Categories (3 items): Including conductive gel, vaginal packing material, and heel lancets, used for medical electrode conductivity, gynecological packing, and neonatal capillary blood collection.

Industry professionals and enterprises are encouraged to promptly download and review the draft guidelines and provide constructive feedback based on practical experience and expertise, contributing to the continuous improvement of China's Class II non-active medical device registration review standards.