MEDICAL DEVICES

Shanghai Specifies Priority Approval Requirements for Class II Medical Devices

18 September 2017

New priority approval procedures for Class II medical devices – those whose use is deemed to require a degree of professional supervision – have been adopted in the Shanghai municipal area. Details of the procedures, which came into effect on 1 September this year, were released by the Shanghai Municipal Food and Drug Administration. More

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CFDA Employees Face Prosecution for Breaching Confidentiality on Drug and Medical Device Testing

29 June 2017

Any employees of the China Food and Drug Administration (CFDA) who breach confidentiality with regard to any information they have become privy to during the course of conducting their duties will now be liable to prosecution. More

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Regulations on Medical Device Usage and Management Amended

09 June 2017

Several amendments to the current Regulations on the Supervision and Administration of Medical Devices have been issued by the State Council. Primarily, these updates relate to the statutory permissions required for the installation of large medical equipment and the relevant departments with responsibility for their use and management. More

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Revised Measures for Assessing Medical Device Standards Issued

10 May 2017

The China Food and Drug Administration (CFDA) has recently issue revised guidelines with regard to the Administrative Measures for Medical Device Standards (Trial Implementation). More

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State Council Issues Guidelines for Reform of Drug and Medical Device Evaluation and Approval System

28 August 2015

The State Council recently issued the Opinions on Reforming the Drug and Medical Device Evaluation and Approval System, clearly setting out the goals, tasks and specific measures for the reform of the evaluation and approval of drugs and medical devices. More

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