Article 1 These Regulations are hereby formulated with a view to strengthening the supervision and
administration of medical devices, ensuring their safety and effectiveness, promote the development of
medical device industry and protecting human health and life safety.
Article 2 All units or individuals engaged in the research and development, production, distribution, use, supervision and administration of medical devices within the territory of the Peoples Republic of China shall
apply with the Regulation.
Article 3 The drug regulatory authority under the State Council is responsible for supervision and
administration of medical devices nationwide. The relevant departments of the State Council are
responsible for the supervision and management of medical devices within their scope of official duty.
Article 4 The local people’s governments at or above the county level should strengthen the leadership of
the supervision and management of medical devices in their respective administrative regions, organize and
coordinate the supervision and management of medical devices and emergency response work in their
respective administrative regions, strengthen the construction of the supervision and management ability of
medical devices, and provide guarantee for the safety of medical devices.
The departments responsible for drug supervision and administration of local people’s governments at or
above the county level shall be responsible for the supervision and administration of medical devices in their
respective administrative regions. The relevant departments of the local people’s governments at or above
the county level shall be responsible for the supervision and management of medical devices within their
respective scope of responsibility.
Article 5 The supervision and management of medical devices follow the principles of risk management, whole process control, scientific supervision and social co governance.
