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.
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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. |
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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. |
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Resources – Documents Download |
- Guidelines For Medical Device Usability Engineering Registration Review (March 19, 2024)
- Application Note On Guideline For The Review Of Medical Device Usability Engineering Registrations (October 8, 2024)
- Guidelines For Review Of Medical Device Usability Engineering Registrations (March 27, 2024)
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.
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