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  • SCW MEDICATH LTD
  • ADD:NO.4 Baolong 6th Road,Baolong industrial Town,Longgang District,Shenzhen ,P.R.China
  • Medical device management supervision and management approach
    Jan 12, 2018

    Article 1 These Measures are formulated in accordance with the "Regulations on the Supervision and Administration of Medical Devices" in order to strengthen the supervision and administration of the operation of medical devices, standardize the operation of medical devices and ensure the safety and effectiveness of medical devices.

    Article 2 Medical equipment business activities and supervision and administration within the territory of the People's Republic of China shall abide by these Procedures.

    Article 3 The State Food and Drug Administration is responsible for the supervision and administration of medical equipment throughout the country. The food and drug supervision and administration department at or above the county level shall be responsible for the supervision and administration of the medical device operation in its own administrative area.

    The superior food and drug supervision and administration department shall be responsible for directing and supervising the lower-level food and drug supervision and administration department to carry out the supervision and administration of the medical device operation.