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    Revisiting 2022 And Looking Into 2023: Regulatory Updates For Medical Device Market Access In China

    Part 1: Clinical Evaluation This section truly discusses the clinical evaluation associated with the 2022 regulatory change. In accordance with order 739, there will be some significant updates to clinical evaluation in 2021. In order to concisely describe preferred clinical…

    Usage Of Real-World Evidence For Medical Devices China Vs. US

    This short video compares the usage of real-world evidence between China and US for medical devices. In 2016, the US FDA published a guide for real-world evidence; three years later, the NMPA published the China Guidance. Real-world data can be…

    Commercial & Regulatory Benefits Of Entering Hainan Pilot Zone

    This short video covers the commercial and regulatory benefits of entering the Hainan Pilot Zone as an international medical device manufacturer. Through the urgent usage programme, you can import your medical devices to the Hainan pilot zone with advantages on…

    Faster China NMPA Approval Via Real-World Study In Hainan

    This short video explains how Real-world study in Hainan can accelerate your NMPA pre-market approval in China. The foreign firm can begin commercial sales and earning money in Hainan once the equipment have arrived at the region's hospitals. The manufacturer…

    Real-World Evidence For NMPA Premarket Clinical Evaluation

    This short video discusses the use of real-world evidence to support your NMPA premarket clinical evaluation. Real-world data can support distinctions between class II and class III medical devices, including IVD. Real-world data can be utilised in conjunction with clinical…

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    Review Guideline Of Animal Studies For Medical DeviceRegistration: Part 1 Decision Principles(2021Revision)

    Announcement On Issuing The Guideline On The Preparation Of Annual Self-Inspection Report On Medical Device Quality Management System (No. 13, 2022)

    GB/T 25102.1—2010 Electroacoustics—Hearing Aids—Part 1: Hearing Aids With Induction Pick-up Coil Input（April 1, 2011)

    GB/T 25102.100 Electroacoustics—Hearing Aids—Part 0: Measurement Of Electroacoustical Characteristics（April 1, 2011)

    YY 0989.7-2017 Implants For Surgery-Active Implantable Medical Devices-Part 7: Particular Requirements For Cochlear Implant Systems (Jan 1, 2018)

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