Regulations for the Supervision and Management of Medical Devices

Original link：http://www.sda.gov.cn/WS01/CL0784/97814.html

The Regulations for the Supervision and Management of Medical Devices, revised at the 39th executive meeting of the Stata Council on February 12, 2014, is hereby promulgated and shall go into effect as of June 1, 2014.

Premier: Li Keqiang

March 7, 2014

Regulations for the Supervision and Management of Medical Devices

(Promulgated as the Decree of the State Council of the People’s Republic of China No. 276 on January 4, 2000, and revised at the 39th executive meeting of the Stata Council on February 12, 2014.)

Chapter I General Provisions

 

Article 1 
The Regulations are hereby formulated with a view to guaranteeing the safety and effectiveness of medical devices and protecting human health and life safety. 

Article 2 
All units or individuals engaged in the research and development, production, distribution, use, supervision and management of medical devices within the territory of the People's Republic of China shall comply with the Regulation.

 Article 3  
The food and drug supervision and management department of the State Council shall be responsible for the supervision and management of national medical devices. Relevant departments of the State Council shall be responsible for the supervision and management relating to medical devices within respective term of reference.

The food and drug supervision and management department of the local people’s government above the level of county shall be responsible for the supervision and management of medical devices within respective administrative region.

Relevant departments of the local people’s governments above the level of county shall be responsible for the supervision and management relating to medical devices within respective term of reference.

The food and drug supervision and management department of the State Council shall support the relevant departments of the State Council in the implementation of the national industrial plans and policies on medical devices.

Article 4 

The State shall implement classified management on medical devices based on the degree of risk. 

Class I Medical Devices are those with lower degree of risk for which the safety and effectiveness can be ensured through routine management。 

Class II Medical Devices are those with medium degree of risk for which further control is required to ensure their safety and effectiveness 

Class III Medical Devices are those with higher degree of risk which must be strictly controlled in respect to safety and effectiveness.

Evaluation on degree of risk should take into account the anticipated purpose, structural characteristics, usage, and other factors of medical devices.

The food and drug supervision and management department of the State Council shall be responsible for formulating the classification rules and classified catalog of medical devices, conduct timely analysis and evaluation on the change of product risk according to the production, distribution, and use of the medical devices, and adjust classified catalog.

When formulating and adjusting the classified catalog, the food and drug supervision and management department of the State Council shall fully listen to the opinions of the medical device manufacturing and operating enterprises, using units, and industrial organizations, and consulting international classification practices of medical devices. 

The classified catalog should be made public.

Article 5 

The R&D of medical devices shall be based on the principle of safety, effectiveness and practicing economy. 

The State while giving play to the role of market mechanism encourages the research and development and innovation of medical devices, boosts the application and generalization of new technology of medical devices, and promotes the development of medical device industry.

Article 6 

Medical device products shall comply with the compulsory national standard for medical devices; if the compulsory national standard is unavailable; comply with the compulsory industrial standard for medical devices.

The catalog of disposable medical devices shall be formulated, adjusted and published by the food and drug supervision and management department of the State Council together with the competent health and family planning department of the State Council. Medical devices that can guarantee its safety and effectiveness when reused shall not be included in the catalog. 

For medical devices that can guarantee its safety and effectiveness when reused after improvements in its design, production process and sterilization technology, etc., they shall be ruled out from the catalog.

Article 7 

The medical devices industrial organization should strengthen industrial self-discipline, promote credit system construction, urge enterprises to conduct production and operation activities according to law, and guide enterprises to be honest and trustworthy.

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