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  • LINKS & AKRA TEAM

    LINKS & AKRA TEAM

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    With the rapid development of the global medical device market, the clinical requirements and regulatory policies of medical devices in the EU and China, as two major global markets, have attracted much attention. In order to help medical device companies better understand the clinical data requirements of the EU and Chinese markets, AKRA TEAM and LINKS CRO jointly held a webinar focusing on the clinical requirements of medical devices in the EU and China, bringing you the most cutting-edge industry insights and practical guidelines.

  • Congratulations on the approval of the Implantable Cardioverter Defibrillator (ICD) from Singular Medical for special review of innovative medical devices

    Congratulations on the approval of the Implantable Cardioverter Defibrillator (ICD) from Singular Medical for special review of innovative medical devices

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    On August 23, 2023, the official website of Center For Medical Device Evaluation of the National Medical Products Administration released the results of the special review application for innovative medical devices (No. 6 of 2023).

  • Industry news| Four Guidelines for Registration and Review of Medical Device Products, including “Guidelines for Registration and Review of Transcatheter Aortic Valve Systems,” were released!

    Industry news| Four Guidelines for Registration and Review of Medical Device Products, including “Guidelines for Registration and Review of Transcatheter Aortic Valve Systems,” were released!

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    Bringing you real-time updates on industry trends

  • Monthly Industry Report - What happened in this month

    Monthly Industry Report - What happened in this month

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    Recently, the NMPA issued guiding principles for the registration and review f animal experimental research on medical devices, part l: decision-making principles (revised in 2021)

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