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CHINA: CFDA released “Guidelines of Mobile Medical Device Registration" - January 2018

CHINA: CFDA released “Guidelines of Mobile Medical Device Registration" - January 2018

  • 2020-02-14 14:55:31

In line with the rapid development of cloud computing, big data and artificial intelligence, mobile technology has been widely used in medical devices. Recently, China Food and Drug Administration (CFDA) released “Guidelines of Mobile Medical Device Registration." The provisions of this guideline was implemented from its effective date on December 29th, 2017.

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CHINA: CFDA publishes the notice on examination of medical device - January 2018

CHINA: CFDA publishes the notice on examination of medical device - January 2018

  • 2020-02-14 14:54:11

Before undergoing registration application in China, medical devices shall be sent to medical device inspection agencies for examination to ensure that the products meet national standards. CFDA has issued a notice on the examination work to ensure the efficiency of registration of medical devices. The details of the notice are as follows:

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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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