NMPA Roundup May 2024

Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in May 2024. These updates are presented by China Med Device, LLC, your partner in Chinese market access.

Policies

From October 8, 2024, NMPA Mandates the Usability Evaluation in Submission Materials

NMPA published the “Medical Devices Usability Engineering Guideline” on March 19, 2024, and released the “Interpretation on Device Usability Engineering Guideline” on April 2. It discussed the scope of application, user interface verification and validation, clinical trial, imported medical devices, combined uses, and the application instructions, etc.

From October 8, 2024, certain medical devices should submit corresponding usability declaration materials based on specific circumstances. For our comprehensive analysis click HERE

NMPA Classifies 191 Medical Devices

The NMPA Medical Device Standardization Administration issued the “First Batch of Medical Device Classification Results for 2024” on April 4, 2024. The document identifies 57 Class III, 101 Class II and 23 Class I medical devices, and 10 combination products.

Classified Class III devices include auxiliary cardiac pump system, vascular interventional control system, intravenous ablation closure microcatheter, spinal surgery implant photo-functional Irradiator, guided catheter control system, etc.

Classified Class II devices include fiber optics for surgical lighting, medical endoscope/fiber optic auxiliary tools, disposable endoscopic knife, fiber optic delivery guides and stone aspirators, etc.

Classified combination products include nasal anti-allergy gel, hydrogel for ophthalmic surgery, medical copper-based dressing, ammonium fluoride silver anti-caries agent, etc. For the full list please click HERE

1380 Institutes Certified to Conduct Clinical Trials in China

“Quality Management Practice Specification for Clinical Trials of Medical Devices (so called China GCP)”, implemented from March 2022, specifies that “Clinical trial sites must be on the NMPA filed institutions for Medical Device Clinical Trial Sites”.

Since February 2005 when NMPA published the first batch of clinical sites, a total of 1380 hospitals became certified to conduct clinical research in China as of April 2024. For more information click HERE

Guidelines & Standards

49 Class III Devices impacted by 2024 Guidelines Revisions Plan

NMPA published the “2024 Medical Device Guidelines Revisions Plan” on April 11, 2024, in which 49 Class III devices and 60 Class II devices are affected. It impacts Class III devices including MRI system, contrast medium high-pressure injection device, X-ray blood irradiation equipment, portable electric infusion pump, ECMO, etc., and Class II devices including home non-invasive ventilator, medical center suction system, visual training device, gastroscopy lubricant, etc. Click HERE for the full list of guidelines

Fast-Track Approvals

NMPA Review Report Released for Ivantis’ Hydrus Microstent

The NMPA granted innovation approvals to Ivantis, Inc.’ hydrus microstent and issued a review report.

This is the fifth report published for overseas manufacturers, after Medtronic, CarboFix Orthopedics, Intuitive Surgical and Abbott. The review report discusses the device by four dimensions: product overview, pre-clinical, clinical and risk-benefit analysis. For our comprehensive article, please click HERE

PMS & QMS

Authenticity Issues Found in Clinical Trial Audit

NMPA issued the clinical trial audit result for an IVD manufacturer on April 16, 2024. The audited firm is Guangdong Hexin. Its Respiratory Syncytial Virus, Influenza A Virus, Influenza B Virus, Adenovirus Antigen Combination Test Kit was applying for IVD registration. The clinical trial was found to have authenticity issues. Click HERE for the detailed findings and the penalties

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• Source: https://chinameddevice.com/nmpa-roundup-may-2024/