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**In the "Regulations on the Supervision and Administration of Medical Jian Qiaofeng Devices".

The Regulations on the Supervision and Administration of Medical Devices is a regulation formulated by Kuanzen in order to ensure the safety and effectiveness of medical devices, protect human health and life safety, and promote the development of the medical device industry.

On January 4, 2000, the People's Republic of China promulgated Order No. 276. On December 21, 2020, the 119th executive meeting revised and passed the "Regulations on the Supervision and Administration of Medical Devices", which will come into force on June 1, 2021.

The state implements classified management of medical devices. The first category is medical devices with a low degree of risk, and the implementation of routine management can ensure their safety and effectiveness; The second category is medical devices with medium risk that need to be strictly controlled and managed to ensure their safety and effectiveness; The third category is the medical devices that have a higher risk and need to take special measures to strictly control and manage them to ensure their safety and effectiveness. Pijan.

Article 20 The development, production, operation and use of medical devices shall comply with the corresponding national standards, industry standards or registered product standards. Medical devices without corresponding standards shall not be produced, operated and used.

Article 21 The production of medical devices that do not meet the standards of registered medical devices shall be deemed to be non-compliant with the medical device industry standards.

Article 22 The medical device supervision and inspection personnel of the drug regulatory department at or above the county level shall supervise and inspect the implementation of the standards by the medical device production, operation and use units in accordance with the regulations. Relevant units and individuals must not refuse or conceal the situation. Medical device supervision and inspection personnel have a duty of confidentiality to the information and samples obtained.

Article 23 False sale of these measures shall be interpreted by the drug regulatory department.

Article 24 These measures shall come into force on May 1, 2002.

Article 1 In order to strengthen the standard work of medical devices and ensure the safety and effectiveness of medical devices, these measures are formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices.

Article 2 Any unit or individual engaged in the development, production, operation, use, supervision and management of medical devices in China shall comply with these measures.

Article 3 Medical device standards are divided into national standards, industry standards and registered product standards.

1) National standards or industry standards refer to standards that need to unify technical requirements nationwide.

2) Registered product standards refer to product standards formulated by manufacturers, which should be able to ensure the safety and effectiveness of the products, and shall be reviewed by the drug regulatory departments at or above the municipal level divided into districts in accordance with the relevant requirements of national standards and industry standards when applying for product registration.

Article 4 The state implements a reward system for medical device standards.