In vitro diagnostic reagents used for blood screening and in vitro diagnostic reagents labeled with radionuclides in accordance with the management of pharmaceuticals, does not fall within the scope of management of these measures. Article IV in vitro diagnostic reagent registration is the Food and Drug Administration in accordance with the application of the applicant for registration, in accordance with the statutory procedures, the proposed listing of its in vitro diagnostic reagents for safety, efficacy research and its results of the systematic evaluation, in order to decide whether or not to agree with the process of its application.
In vitro diagnostic reagents for the record is the filing of the record to the Food and Drug Administration to submit the record information, food and drug supervision and management of the filing of the information submitted to the archives for inspection. Article V in vitro diagnostic reagent registration and filing should follow the principles of openness, fairness and justice. Article VI of the first category of in vitro diagnostic reagents for the record management, the second and third category of in vitro diagnostic reagents for registration management.
The first class of in vitro diagnostic reagents within the record, the filing of the municipal food and drug supervision and management department to submit the record information.
In vitro diagnostic reagents within the second category by the provinces, autonomous regions and municipalities directly under the Central Food and Drug Administration for review, approval and issue of medical device registration certificate.
The third in vitro diagnostic reagents within the territory of the State Food and Drug Administration for review, approval and issue of medical device registration certificate.
Imported Class I in vitro diagnostic reagents for the record, the filer to the State Food and Drug Administration to submit the record information.
Import of Class II, Class III in vitro diagnostic reagents by the State Food and Drug Administration for review, approval and issue of medical device registration certificate.
Hong Kong, Macao, Taiwan in vitro diagnostic reagent registration, filing, with reference to the import of in vitro diagnostic reagents. Article VII in vitro diagnostic reagents registrant, the filing of their own name to market the product, the product is legally responsible. Article VIII of the Food and Drug Administration in accordance with the law and timely release of in vitro diagnostic reagents registration, filing related information. Applicants can inquire about the progress and results of the approval, the public can access the results of the approval. Article IX The state encourages the research and innovation of in vitro diagnostic reagents, innovative in vitro diagnostic reagents to implement special approval, to promote the promotion and application of new in vitro diagnostic reagent technology, and to promote the development of medical device industry. Chapter II Basic Requirements Article 10 The applicant for registration of in vitro diagnostic reagents and the filer shall establish a quality management system related to product development and production, and maintain effective operation.
In vitro diagnostic reagents in accordance with the innovative medical device special approval procedures for approval of the domestic application for registration, the sample entrusted to other enterprises, should be entrusted with the corresponding production range of medical devices manufacturer; does not belong to the innovative medical devices in accordance with the innovative medical device special approval procedures for approval of the domestic application for registration of in vitro diagnostic reagents, the sample shall not be entrusted to other enterprises. Article XI of in vitro diagnostic reagents for registration or filing affairs should have the appropriate professional knowledge, familiar with the medical device registration or filing management of laws, rules, regulations and technical requirements. Article XII of in vitro diagnostic reagents product development, including: the selection of raw materials, preparation, production process to determine the product, the formulation of product technical requirements, product stability studies, positive judgment value or reference interval determination, product analysis and performance assessment, clinical evaluation and other related work.
The applicant or the filer can refer to the relevant technical guidelines for product development, can also be used in different experimental methods or technical means, but should explain its reasonableness. Article 13 The applicant or the filer to apply for registration or for the record, should follow the requirements of in vitro diagnostic reagents safe and effective, to ensure that the development process is standardized, and all data are true, complete and traceable. Article XIV application for registration or for the record information should be used in Chinese. According to the translation of foreign language information, the original text should be provided at the same time. Citation of unpublished literature, should provide the owner of the data should be licensed to use the documents.
Applicants and filers are responsible for the authenticity of the information. Article XV application for registration or for the record of imported in vitro diagnostic reagents, should be registered in the applicant or filer or production address in the country (region) has been approved for sale.
The applicant or the filing of the applicant's place of registration or production address in the country (region) is not the product as a medical device management, the applicant or the filing of the applicant is required to provide the relevant documents, including the place of registration or production address in the country (region) to authorize the sale of the product on the market documents. Article XVI of foreign applicants or filers should be set up in China through its representative organizations or designated Chinese enterprises as agents, with foreign applicants or filers to carry out the relevant work.
In addition to handling the registration or filing of in vitro diagnostic reagents, the agent shall also undertake the following responsibilities:
(1) liaison with the corresponding food and drug supervision and management departments, the overseas applicant or filer;
(2) truthfully and accurately conveying the relevant laws and regulations and technical requirements to the applicant or filer;
(3) collecting post-market In vitro diagnostic reagent adverse event information and feedback to the foreign registrant or filer, and at the same time report to the appropriate food and drug supervision and management authorities;
(d) coordination of in vitro diagnostic reagents after the market recall of the product, and report to the appropriate food and drug supervision and management authorities;
(e) other product quality and after-sales service related to the joint and several responsibility.