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 INDIA: Classification of medical devices and in vitro diagnostic medical devices under the provisions of the Medical Devices Rules, 2017 - December 2017

INDIA: Classification of medical devices and in vitro diagnostic medical devices under the provisions of the Medical Devices Rules, 2017 - December 2017

  • 2020-02-14 15:20:15

India's central medical device regulator, the Central Drugs Standards Control Organization (CDSCO) published, on November 1, 2017, a revised risk classification of medical devices and IVDs on the basis of their intended use. This is an extremely important development for the medical device and IVD industry because from January 1, 2018 onwards,

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CFDA Requires Applicant Name of Foreign Medical Device to Be in Chinese - November 2017

CFDA Requires Applicant Name of Foreign Medical Device to Be in Chinese - November 2017

  • 2020-02-15 06:22:45

According to the “Regulations for the Supervision and Administration of Medical Devices,” "Provisions for Medical Device Registration,” “Provisions for In-vitro Diagnostic Reagent Registration,” and “Provisions for Instructions and Labels of Medical Devices,” when applying for medical device listing in China, the applicant name shall be in Chinese.

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