Regulations on Supervision and Administration of Medical Devices (Revised in 2017)
Regulations on Supervision and Administration of Medical Devices (Revised in 2017)
Regulations on Supervision and Administration of Medical Devices (Revised in 2017)
Order of the State Council of the People's Republic of China No.680
May 4, 2017
(Promulgated by the Order of the State Council of the People's Republic of China No.276 on January 4, 2000; revised and adopted at the 39th executive meeting of the State Council on February 12, 2014; and revised by the Decision of the State Council on Revising the Regulations on the Supervision and Administration of Medical Devices on May 4, 2017)
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 Activities in terms of development, manufacture, operation and utility as well as supervision and administration of medical devices within the territory of China shall be subject to these Regulations.
Article 3 The food and drug supervision and administration 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 related to medical devices within their scope of duties respectively.
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 of 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 of medical devices by risk level.
Class I medical devices with low risk, whose safety and effectiveness can be guaranteed through routine administration.
Class II medical devices with medium risk, whose safety and effectiveness can be ensured by strict control and administration.
Class III medical devices with high risk, whose safety and effectiveness can be ensured by strict control and administration through special measures.
To evaluate the risk level of a medical device, expected purpose, structural features, method of application and other factors thereof shall be considered.
The food and drug supervision and administration department under the State Council shall be responsible for working out classification rules and contents of classified 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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