By kingandwood Mallesons’ Healthcare Group

On 31 March 2014, Chinese government released the revised Regulations on the Supervision and Administration of Medical Devices (“Revised Regulations”). The Revised Regulations will come into effective on 1 June 2014, presenting following major changes:

 Classification and Supervision System Adjustment

According to the Revised Regulations, medical devices are still supervised and managed under a Class I, Class II and Class III system based on the risk to the users. However, the supervisory system has been changed with below highlights.
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