National laws and regulations on in vitro diagnostic reagents

Announcement of the State Administration of Pharmaceutical Products on the Classified Management of in vitro Diagnostic Reagents (State Drug Administration Office [2002] No.324) In order to do a good job in the supervision and management of in vitro diagnostic reagents, the State Drug Administration issued the Notice on Standardizing the Management of in vitro Diagnostic Reagents No.5438+0 (State Drug Administration [2006 5438+0] No.357) in July 2006, which clarified the national medicine. More than one year's practice shows that its management mode is not suitable for the actual situation of in vitro diagnostic reagent management in China and needs to be adjusted accordingly. In order to further strengthen the supervision and management of in-vitro diagnostic reagents, reflect the characteristics of the supervision and management of in-vitro diagnostic reagents and the actual situation of the supervision and management of in-vitro diagnostic reagents in China at present, and straighten out the relationship, according to the relevant provisions of the Drug Administration Law of People's Republic of China (PRC) and the Regulations on the Supervision and Management of Medical Devices, the management adjustment of in-vitro diagnostic reagents is announced as follows: 1. Classified management of in-vitro diagnostic reagents, and in-vitro biological diagnostic reagents are managed according to categories such as drugs, in-vitro chemical and biochemical diagnostic reagents. In vivo diagnostic reagents are all managed according to drugs. Classification of in vitro diagnostic reagents: (1) In vitro biological diagnostic reagents for drug management include: 1. Blood group and tissue matching reagent; 2. Microbial antigens, antibodies and nucleic acid detection reagents; 3. Tumor labeling reagent; 4. Immunohistochemistry and human tissue cell reagents; 5. Human gene detection reagent; 6. biochip; 7. Allergy diagnostic reagents. (2) In vitro reagents for medical device management include: 1. Clinical basic test reagents; 2. Clinical chemical reagents; 3. Blood gas and electrolyte determination reagents; 4. Vitamin determination reagent; 5. Histochemical staining of cells; 6. Autoimmune diagnostic reagents; 7. Microbial test reagents. Three, the technical requirements and procedures for the registration and declaration of in vitro diagnostic reagents. , shall be separately formulated and promulgated by the Drug Registration Department and the Medical Device Department of the State Pharmaceutical Products Administration. Four, in vitro diagnostic reagents production and business units should be in accordance with the above classification principle, according to the provisions of the "Regulations on the supervision and administration of medical devices in People's Republic of China (PRC)", to the local provincial drug administration for issuing (renewal) drugs or medical devices production and business license or registration certificate. Five, has obtained the "imported drugs registration certificate", "medical device registration certificate" of in vitro diagnostic reagents, should be based on the above classification principle, when the registration certificate expires, respectively, according to the relevant registration regulations and technical principles for renewal. Six, according to the domestic drug declaration and a considerable number of in vitro diagnostic reagents have been approved, according to the above classification principle, if it should be classified into medical device management, it must be completed before February 3, 20031day. Seven, special in vitro diagnostic reagents (random reagents) for specific diagnostic instruments, such as in vitro biological diagnostic reagents, should also apply for medical devices and drugs registration or import registration certificate in accordance with the above provisions. Eight, this announcement since June 2002 10. If the previously issued management regulations are inconsistent with this announcement, this announcement shall prevail. State Administration of Medical Products, September 2002 17.