Regulations on the Supervision and Administration over Medical Devices (Revised in 2014)
Regulations on the Supervision and Administration over Medical Devices (Revised in 2014)
Regulations on the Supervision and Administration over Medical Devices (Revised in 2014)
Order of the State Council of the People's Republic of China No.650
March 7, 2014
The Regulations on the Supervision and Administration over Medical Devices, which were revised and adopted at the 39th executive meeting of the State Council on February 12, 2014, are hereby promulgated and shall come into force as of June 1, 2014.
Premier: Li Keqiang
Regulations on the Supervision and Administration over Medical Devices
(promulgated under the Order of the State Council of the People's Republic of China No.276 on January 4, 2000 and revised and adopted at the 39th executive meeting of the State Council on February 12, 2014)
Chapter I General Provisions
Article 1 The Regulations on the Supervision and Administration over Medical Devices (hereinafter referred to as the "Regulations") are hereby formulated for the purposes of ensuring the safety and effectiveness of medical devices and guaranteeing the human health and safety of lives.
Article 2 For the research and development, production, operation or use of, and supervision and administration over medical devices within the territory of the People's Republic of China, the Regulations shall be observed.
Article 3 The food and drug supervision and administration department under the State Council shall be responsible for the supervision and administration over medical devices throughout the country. The relevant departments of the State Council shall be responsible for the supervision and administration related to medical devices within their respective scope of duties.
The food and drug supervision and administration departments of the local people's governments at county level or above shall be responsible for the supervision and administration over medical devices within their respective administrative regions. The relevant departments of the local people's governments at county level or above shall be responsible for the supervision and administration related to medical devices within their respective scope of duties.
The food and drug supervision and administration department under the State Council shall coordinate with the relevant departments of the State Council in implementing the national industrial plans and policies on medical devices.
Article 4 The state adopts classified administration over medical devices by risk level.
Class I medical devices shall refer to those devices with low risk whose safety and effectiveness can be guaranteed through routine administration.
Class II medical devices shall refer to those devices with moderate risk whose safety and effectiveness should be ensured by strict control and administration.
Class III medical devices shall refer to those devices with relatively high risk whose safety and effectiveness should be ensured by taking special measures to conduct strict control and administration.
When the risk level of medical devices is assessed, such factors as desired purpose, structural feature and usage of medical devices shall be taken into consideration.
The food and drug supervision and administration department under the State Council shall be responsible for working out classification rules and classification contents of medical devices and timely analyze and assess, according to the production, operation and use of medical devices, the change in risk of medical devices and then adjust the classification contents.
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