CFDA 2016 Annual Report for Medical Device Registration (Chinese Version)

China Food and Drug Administration (CFDA) recently released the 2016 Annual Report for Medical Device Registration, which describes the overview of medical device registration in 2016, the acceptance of medical device registration application, the review and approval of medical device registration, the review and approval of innovative medical device in 2016, and other situation about medical device registration in 2016.

This report is available in Chinese language.

China CFDA 2016 Drug Review Annual Report (Chinese Version)

China Food and Drug Administration (CFDA) recently released the 2016 Drug Review Annual Report. The Annual Report describes the general situation of drug registration acceptance, review and approval in 2016, and analyzes the data of acceptance and review in 2016 for chemical drugs, traditional Chinese medicines and biological products respectively.

Regulation on in vitro diagnostic medical devices repealing 98/79/EC

Position of the Council at first reading with a view to the adoption of a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

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Position of the Council at first reading with a view to the adoption of a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU