Measures for the administration of registration of in vitro diagnostic reagents

The Administrative Measures for the Registration of in vitro Diagnostic Reagents stipulates that enterprises that produce and sell in vitro diagnostic reagents need to register before they can be listed for sale. At the same time, enterprises are required to establish and improve the quality management system, monitoring and evaluation mechanism. Ensure product quality and safety.

The Administrative Measures for the Registration of in vitro Diagnostic Reagents is a regulation promulgated by China Food and Drug Administration, aiming at strengthening the supervision of in vitro diagnostic reagents and ensuring people's health and safety. The management measures require that all enterprises engaged in the production and sales of in vitro diagnostic reagents (IVD) must be registered and licensed before they can be listed for sale. Specifically, enterprises need to apply to China Food and Drug Administration, provide different application materials according to their categories, conduct examination, and obtain registration certificates and sales licenses only after passing the assessment. In addition, the management measures also clarify the quality management requirements that enterprises should follow in the production and sales process, and require the establishment and improvement of quality management system, monitoring and evaluation mechanism to ensure product quality and safety. In short, the implementation of the Administrative Measures for the Registration of in vitro Diagnostic Reagents is conducive to standardizing the market order, strengthening supervision and ensuring the legitimacy of people's health and rights.

What materials should I provide to apply for the registration certificate of in vitro diagnostic reagents? Specific requirements vary according to different categories, but generally the following materials are needed: product registration application form; Product registration application report; Manufacturer's license; Product description, labels and packaging; Research report, clinical trial report, etc.

The Administrative Measures for the Registration of in vitro Diagnostic Reagents requires the implementation of registration examination and approval, the establishment of a sound quality management mechanism, the standardization of market order, and the maintenance of people's health and rights and interests. Therefore, enterprises should fully realize the importance of this management mode, strictly abide by relevant laws and regulations, ensure the quality and safety of their own products, and safeguard the actual interests of the people.

Legal basis:

Article 14 of the Measures for the Administration of Registration of in vitro Diagnostic Reagents. Units and individuals engaged in the production and sale of in vitro diagnostic reagents must obtain the registration certificate and sales license as stipulated in this Law.