Chapter I General Provisions

Article 1 These Regulations are formulated for the purpose of ensuring the safety and effectiveness of medical devices, safeguarding human health and life safety, and promoting the development of the medical device industry.

Article 2 These Regulations shall apply to the research and development, production, management and use of medical devices within the territory of the People's Republic of China as well as their supervision and administration.

Article 3 The drug regulatory department under the State Council shall be responsible for the supervision and administration of medical devices throughout the country.

The relevant departments of the State Council shall be responsible for the supervision and administration of medical devices within the scope of their respective functions and duties.

Article 4 The local people's government at or above the county level shall strengthen the leadership of the supervision and administration of medical devices within its administrative region, organize and coordinate the supervision and administration of medical devices within its administrative region as well as the emergency response work, strengthen the capacity building of the supervision and administration of medical devices, and provide guarantee for the safety work of medical devices.

The departments responsible for drug supervision and administration under the local people's governments at or above the county level shall be responsible for the supervision and administration of medical devices within 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 administration of medical devices within their respective functions and duties.

Article 5 The supervision and administration of medical devices shall follow the principles of risk management, whole-process control, scientific supervision and social co-governance.

Article 6 The State shall carry out classified management of medical devices according to the degree of risk.

The first category is low risk degree, the implementation of routine management can ensure its safety and effectiveness of medical devices.

The second category is the medical devices with moderate risks, which need to be strictly controlled and managed to ensure their safety and effectiveness.

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