Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in July 2023. These updates are presented by China Med Device, LLC, your partner in Chinese market access.
Policies
More Class II & III Medical Devices Exempted from Clinical Trial
The NMPA published the final version of “Clinical Evaluation Exempt Catalog for Medical Devices” on July 20, 2023, which includes 1025 medical devices.
Compared with the 2021 catalog, 15 medical devices are added, including disposable intracranial retraction and fixation catheter, neuromonitoring endotracheal intubation, medical air compressor, negative pressure assisted venous drainage controller, single/multi-part prefabricated cranioplasty plates and fasteners, surgical membrane, etc.
See how the exempt catalog works and what Class III devices are in the newest catalog.
Latest NMPA Device Classifications Released
The NMPA Medical Device Standardization Administration issued the “Second Batch of Medical Device Classification Results for 2023” on July 13. The document identifies 71 Class III, 80 Class II and 35 Class I medical devices, and 5 combination products. It is the summary of classification requests submitted by overseas and domestic manufacturers.
Identified Class III devices include prostate surgery navigation system, electromagnetic stimulation of the neuro-navigation system, mechanical thrombus resection power system, disposable bipolar RF ablation electrodes, single-use intracranial guided dilation catheter, etc.
Combination products include medicated far-infrared sticker, antiviral nasal spray, nitric oxide nasal sprayer, etc. View more information.
Guidelines & Standards
How is CGMS Approved? NMPA Final Guideline Reveals
The CMDE released the “Guideline on Continuous Glucose Monitoring System” on July 18, 2023. It is the finalized version from draft issued in September 2022. The guideline applies to invasive CGMS and excludes non-invasive and implantable CGMS.
The highlights in the 58-page guideline include registration unit, predicate comparison circumstances and special research materials. Read our comprehensive review.
Key Review Points Issued for Ultrasound Imaging AI Software
The CMDE published the “Key Points of Ultrasound Imaging Artificial Intelligence Software (Process Optimization)” on July 10, 2023.
The document is applicable to AI software for process optimization in ultrasound imaging products. The products should be used by doctors with ultrasound diagnosis qualifications. Highlights of the Key Points include data collection, data annotation, dataset construction, etc. Read more information about it.
Thirty Guidelines Issued in July
The NMPA published 30 guidelines in July 2023, to guide manufacturers for local type testing, pre-clinical, clinical studies, and regulatory submissions.
Registration guidance impact AI software for pathological images, AI software for blood disease flow cytometry, ECMO consumable products, ventilator, blood melting device, respiratory humidifier, intestinal hydrotherapy machine, etc. View more information about the July NMPA 2023 guidelines.