China NMPA Newsletter – July 2024


2024-08-22

Featured Articles

NMPA Medical Device New Approvals in June 2024

In June 2024, NMPA approved 134 medical devices, including 14 Class III imported products, 11 Class II imported products, and 109 Class III domestic products.

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

Medical Device/IVD Manufacturer Category
OptiCross 35 15 MHz Peripheral Imaging Catheter Boston Scientific Corporation Class III
Cochlear Implant MED-EL Elektromedizinische Geräte GmbH Class III
Afterloader System Varian Medical Systems, Inc. Class III
SPECT/CT GE Medical Systems Israel, Functional Imaging Class III
HeartLight®X3 Catheter CardioFocus, Inc. Class III
ENT Treatment Guidance System Medtronic Navigation, Inc. Class III
Urgoclean Ag Pad LABORATOIRES URGO Class III
RAPID RHINO Epistaxis Device ArthroCare Corporation Class III
Arterial Catheter Haolang Medical USA Corporation Class III
FIBERGRAFT BG Putty Bone Graft Substitute Prosidyan, Inc. Class III
Sling for female urinary incontinence Promedon S.A. Class III
STANDARDTM Q HIV 1/2 Ab 3-Line Test SD Biosensor, Inc. Class III
 
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China NMPA and NHC’s Announcement on the Temporary Importation and Use Management Requirements of urgently needed medical devices by medical institutions

On July 19, 2024, China NMPA published an announcement on imported medical devices. In this announcement, imported medical devices needed for prevention and treatment of life-threatening diseases now are allowed to apply for sales in designated hospitals without obtaining NMPA registration certificates.

 

China’s NMPA Approves 277 Innovative Medical Devices

In recent years, China’s NMPA has been continuously promoting the innovation and development of the medical device industry. The NMPA has implemented a streamlined approval process for innovative medical devices, ensuring product safety, effectiveness, and quality control. This approach includes dedicated personnel, comprehensive guidance, and priority review, all while maintaining rigorous standards and procedures. As of now, the NMPA has approved 277 innovative medical devices for market release.

 

New Chinese Medical Aesthetics Market Website

Welcome to our new web page, “Medical Aesthetics — Welcome to the Chinese Market.” As the medical aesthetics landscape undergoes significant transformations, our platform serves as a comprehensive guide to the latest developments in the Chinese market. Explore in-depth insights into the regulatory upgrades introduced by Chinese authorities, shaping a new era of compliant development in 2022. From standardizing industrial standards to the impact on specific products like Ultrasonic Aesthetic and RadioFrequency devices, we unravel the intricacies of this evolving industry. Discover the opportunities presented by the Hainan Boao Lecheng Medical Tourism Pilot Zone, providing instant market access and regulatory benefits for medical aesthetic products. Stay informed with our featured news section, keeping you abreast of the latest trends and breakthroughs in the field of Medical Aesthetics. Join us on this journey as we navigate the dynamic landscape of medical aesthetics in China and strive to be at the forefront of industry knowledge and innovation.

 
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.