In vitro diagnostic reagents used for blood screening in accordance with the management of drugs, in vitro diagnostic reagents labeled with radionuclides do not fall within the scope of management of these measures. Article IV in vitro diagnostic reagent registration refers to in vitro diagnostic reagent registration applicant (hereinafter referred to as the applicant) in accordance with the statutory procedures and requirements for in vitro diagnostic reagent registration application, drug supervision and management departments in accordance with the laws and regulations, based on scientific knowledge, safety, efficacy, and quality and controllability of the review, and decide whether or not to agree with the application of the activities.
In vitro diagnostic reagents for the record refers to in vitro diagnostic reagents for the record (hereinafter referred to as the filer) in accordance with the statutory procedures and requirements to the Drug Administration to submit the record information, drug supervision and management of the filing of information submitted for the record of the activities. Article V State Drug Administration in charge of the national in vitro diagnostic reagent registration and filing management, is responsible for the establishment of in vitro diagnostic reagent registration and filing management system, according to law, the organization of the territory of the third category and the import of the second and third category of in vitro diagnostic reagents review and approval of imports of the first in vitro diagnostic reagents for the record, as well as the supervision and management of the relevant work, the registration of in vitro diagnostic reagents and filing of supervision and guidance of the local work. Article 6 Article VI of the State Drug Administration Medical Devices Technical Review Center (hereinafter referred to as the State Board of Instrumentation Review Center) is responsible for the territory of the third and imported second, third class in vitro diagnostic reagents product registration application, change the application for registration, renewal of the application for registration and other technical review.
State Drug Administration Medical Devices Standard Management Center, China Food and Drug Administration Research Institute, the State Drug Administration Food and Drug Administration Audit and Inspection Center (hereinafter referred to as the State Board Audit and Inspection Center), the State Drug Administration Drug Evaluation Center, the State Drug Administration Administrative Matters Acceptance Service and Complaints and Reporting Center, the State Drug Administration Information Center. Other professional and technical institutions, in accordance with the responsibilities of the implementation of in vitro diagnostic reagents supervision and management of in vitro diagnostic reagents required for the management of standards, classification and definition, testing, verification, monitoring and evaluation, certification and delivery, as well as the corresponding information technology construction and management and other related work. Article 7 Provinces, autonomous regions and municipalities directly under the Central Drug Administration is responsible for the administrative region of the following in vitro diagnostic reagent registration related management:
(a) the territory of the second type of in vitro diagnostic reagent registration review and approval;
(b) the territory of the second and third type of in vitro diagnostic reagent quality management system verification;
(c) according to law to organize the clinical trial of medical devices Institutions and supervision and management of clinical trials;
(D) the municipal level responsible for drug supervision and management of the first class of in vitro diagnostic reagents within the supervision and guidance of the department for the record.
Provinces, autonomous regions and municipalities directly under the central drug supervision and management department set up or designated professional and technical institutions of medical devices, to undertake the implementation of the supervision and management of in vitro diagnostic reagents required for technical review, testing, verification, monitoring and evaluation.
Settlement of municipalities responsible for drug supervision and management departments responsible for the territory of the first class of in vitro diagnostic reagents product record management. Article VIII in vitro diagnostic reagent registration and filing follow the law, science, openness, fairness and justice. Article IX of the first class of in vitro diagnostic reagents product record management. The second and third category of in vitro diagnostic reagents to implement product registration management.
The first in vitro diagnostic reagents within the territory for the record, the filing of the municipal level responsible for drug supervision and management of the municipal level to submit the filing information.
In vitro diagnostic reagents within the second class of provinces, autonomous regions and municipalities directly under the central drug supervision and management department for review, approval and issue of medical device registration certificate.
In vitro diagnostic reagents within the third category by the State Drug Administration for review, approval and issue of medical device registration certificate.
Imported the first class of in vitro diagnostic reagents for the record, the filer to the State Drug Administration to submit the record information.
Imported second, third class of in vitro diagnostic reagents by the State Drug Administration for review and approval of the medical device registration certificate. Article X in vitro diagnostic reagents registrant, the filing should strengthen the in vitro diagnostic reagents quality management throughout the life cycle of the development, production, operation and use of in vitro diagnostic reagents throughout the process of safety, efficacy and quality of controllability according to law. Article XI of the State Drug Administration of the clinical urgency of in vitro diagnostic reagents to implement priority approval, innovative in vitro diagnostic reagents to implement special approval. Encourage the research and innovation of in vitro diagnostic reagents, and promote the high-quality development of the medical device industry.