China Releases Compilation Plan for Medical Device Registration Review Guidelines

Core Purpose

The core purpose of this announcement is to give relevant organizations an early view of the direction of upcoming review work.

●Help companies preparing Class II and Class III medical device registrations understand where review expectations are heading

●Give the industry time to prepare data and verification strategies

●Provide a clearer basis for future registration submissions

Coverage

The plan broadly covers the following Class II and Class III medical device categories:

●Implantable and interventional devices, such as implantable neurostimulation electrodes, intracranial liquid embolization devices, and artificial blood vessels

●Treatment equipment, such as laser photodynamic therapy devices, picosecond Nd:YAG laser treatment devices, and hyperbaric oxygen chambers

●Orthopedic implants, such as patella claws, cranial clips or locks, and certain knee joint prostheses

●Dental products, such as gingival retraction materials, tooth whitening products, and dental abutments

●In vitro diagnostic reagents, such as Treponema pallidum antibody tests, hepatitis B surface antigen tests, and cervical cancer methylation tests

●Imaging and diagnostic equipment, such as infrared thermal imagers, transcranial Doppler ultrasound blood flow analyzers, and dual-energy X-ray bone densitometers

●Rehabilitation and physiotherapy devices, such as cognitive impairment rehabilitation equipment, visual rehabilitation equipment, and tinnitus rehabilitation equipment

●Surgical instruments, such as biopsy guns, puncture needles, and spinal surgery channel instruments

●Infusion and puncture products, such as insulin pump reservoirs, single-use arterial and venous cannulas, and pen injectors

●Disinfection and sterilization devices, such as boiling disinfectors, ozone disinfectors, and ethylene oxide sterilizers

●Medical aesthetics and dressing products, such as recombinant collagen products for plastic and aesthetic use, medical drapes, and surgical non-woven dressings

●Artificial intelligence medical devices, such as AI-assisted diagnostic devices, AI multi-classification decision support devices, and traditional Chinese medicine auxiliary diagnosis software

●Traditional Chinese medicine devices, such as moxibustion devices, warm-needle therapy equipment, and intradermal needles

●Nursing consumables, such as single-use rectal tubes, negative pressure drainage devices, and seawater nasal irrigation solutions

●Laboratory analysis instruments, such as flow cytometers, electrolyte analyzers, and urine analysis systems

Conclusion

This notice is an important roadmap for the medical device industry over the next two years. Companies should closely monitor registration review guideline developments related to their own products and use the plan to better advance preparation work.