China NMPA Newsletter – June 2024


2024-07-15

 
Featured Articles

NMPA Medical Device New Approvals in May 2024

In May 2024, NMPA approved 265 medical devices, including 40 Class III imported products, 27 Class II imported products, and 197 Class III domestic products.

Below is a list of approved Class III and Class II imported products in May 2024.

Medical Device/IVD Manufacturer Category
Patient monitor 日本光电工业株式会社 Class III
Ethicon Megadyne Electrosurgical Generator Megadyne Medical Products Inc. Class III
Dry Eye Treatment Instrument Lumenis Ltd. Class III
bright CT (Oral and maxillofacial cone beam computed tomography equipment) (주)덴티움아이씨티사업부 Class III
3D Printed Total Knee System Smith & Nephew, Inc. Class III
NobelProcera Abutment Titanium Nobel Biocare AB Class III
Self-etching/self-adhesive resin cement ITENA CLINICAL Class III
Avenir Complete Hip System Zimmer Inc. Class III
Agent™ MONORAIL™ Paclitaxel-Coated PTCA Balloon Catheter Hemoteq AG Class III
DIOnavi-P.MAX DIO Corporation Class III
iStent inject W Trabecular Micro-Bypass System Glaukos Corporation Class III
Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit Argon Medical Devices, Inc. Class III
 
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NMPA Issues Draft Guidelines for Inspection of Medical Device Clinical Trial Sites

On June 14, 2024, China NMPA has released this new guideline. This guideline aims to enhance the management of clinical trial institutions for medical devices, ensuring compliance with regulatory standards and safeguarding public health.

 
 
Resources – Documents FAQ for China Submission

The FAQ for China Submission highlights updates in biological evaluation standards for passive medical devices, including the new GB/T 16886.1 that focuses on physicochemical characterization and selective long-term toxicity tests. It also addresses the conditions under which cytotoxicity testing, dual-route exposure, and chemical characterization are required, emphasizing that equivalence comparison and specific evaluations are essential for ensuring device safety.

 
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Resources – Documents Download
 
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Resources – Webinar/Short Videos

UK-China Medical Device Access to China

Session 1 -Navigating Medical Device Lifecycle and Compliance in China

A session on UK-China Medical Device Access to China is scheduled for January 17, 2024, focusing on navigating the medical device lifecycle and compliance in China. The agenda includes the introduction and launch of a report, an overview of medical device regulation in China for UK SMEs, strategies to expedite premarket approvals, and insights into post-market surveillance and compliance obligations. The session aims to provide information on key regulations, approval processes, and best practices for UK medical device companies seeking access to the Chinese market. The event will conclude with a Q&A session.

Session 2-Targeting Unmet Medical Needs in China’s Growing Market

Session 2 on targeting unmet medical needs in China’s growing market, features an agenda encompassing an introduction, an exploration of the landscape of unmet medical needs in China, with a focus on areas where UK MedTechs can excel, discussion of “Green Channels” for market access of UK medical devices to China, highlighting expedited pathways for entry into the Chinese market, and concluding with a Q&A session.

Please click here to review the record of BradyKnows webinar and short videos.