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    "Medical device registration management approach" and other

    The newly revised "medical device supervision and Administration Ordinance" (hereinafter referred to as the "Regulations") has been implemented since June 1, 2014. For the implementation of the "Regulations" in cooperation, in-depth research, repeated demonstration and solicit the views of the parties based on the State Food and Drug Administration for revision of the "medical device registration" and "in vitro diagnostic reagent registration", "medical instructions and labeling regulations", "medical device production supervision and management measures", "medical equipment business supervision and management measures" and five regulations. Five regulations has been passed in June 27 by the executive meeting of the General Administration, in July 30th 4, respectively in the administration of 5, 6, 7, 8, announced, to be implemented in October 1, 2014.
    The new revision of the five regulations to implement the Party Central Committee and the State Council on the establishment of the transformation of government functions and deepening the reform of the administrative examination and approval system of food and drug supervision system, speed up the spirit of the most stringent covering the whole process, adhere to the risk management, the entire process of governance, social governance, governance, governance efficiency responsibility concept, encourage innovation, outstanding enterprises responsibility, strengthen the research, production, management and other aspects of the regulation, according to the "Regulations" the relevant provisions of the "Regulations" of the refinement, the overall design of the monitoring system of medical devices really landing".
    Five regulations in accordance with the medical device risk level, set scientific approval and filing system, the detailed provisions of the product registration (for the record) as well as production, operating permit conditions, procedures, time limit, clear the main duties and responsibilities of enterprises, detailed instructions and labeling requirements, strengthen the means and measures of Supervision Inspection and supervision departments, strict legal liability for medical device registration (for the record) and production management provides clear guidance, provide strong support to strengthen the supervision and management of medical devices.
    The five regulations promulgated for the improvement of medical device regulatory system, standardize medical market order, and promote the healthy development of medical equipment industry, to ensure safe and effective medical equipment, it has important significance to protect the human health and life safety. The next step, the General Administration will actively carry out the interpretation of the five regulations and related publicity and training work, and lay a good foundation for the implementation of the rules and regulations.