I. Basis for Handling

Article 16 of the "Regulations of the People's Republic of China on Certification and Accreditation" (State Council Decree No. 390): "Inspection bodies and laboratories that issue data and results with a probative effect to the public shall possess the basic conditions and capabilities stipulated by relevant laws and administrative regulations, and may only engage in corresponding activities after being accredited according to law. The accreditation results shall be announced by the certification and accreditation supervision and administration department of the State Council."

Article 57 of the "Food Safety Law of the People's Republic of China": "Food inspection institutions may engage in food inspection activities only after obtaining qualification accreditation in accordance with the national regulations on certification and accreditation."

Article 57 of the "Regulations on the Supervision and Administration of Medical Devices": "The qualification accreditation of medical device inspection institutions shall be uniformly managed in accordance with relevant national regulations. Only inspection institutions accredited by the certification and accreditation supervision and administration department of the State Council in conjunction with the food and drug supervision and administration department of the State Council may conduct inspections on medical devices."

II. Application Conditions

1. Be a legal person or other organization established according to law and capable of assuming corresponding legal liabilities;

2. Have inspection and testing technicians and management personnel suitable for the inspection and testing activities it engages in;

3. Have a fixed workplace with an environment that meets the requirements for inspection and testing;

4. Possess the necessary inspection and testing equipment and facilities for conducting inspection and testing activities;

5. Have and effectively operate a management system that ensures the independence, impartiality, scientific rigor, and integrity of its inspection and testing activities;

6. Comply with special requirements stipulated by relevant laws, regulations, standards, or technical specifications.

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