Seven major violations of in vitro diagnostic reagents (IVD)

In vitro diagnostic reagent (IVD) involves the whole process of diagnosis and treatment of diseases such as diagnosis, treatment plan selection, curative effect evaluation, etc. The demand is large, which is related to the vital interests of the people. The State Administration has successively issued the notice on printing and distributing the work plan for sampling and testing of in vitro diagnostic reagents, the notice on printing and distributing the work plan for risk investigation of in vitro diagnostic reagents, the notice on printing and distributing the work plan for special rectification of in vitro diagnostic reagents, and the notice of the general office of the State Administration on printing and distributing the work plan for quality evaluation and comprehensive management of in vitro diagnostic reagents.

1. production, sale and use of in vitro diagnostic reagents without medical device registration certificate

In vitro diagnostic reagents that have not obtained a medical device registration certificate mainly include the following situations:

1. Production, sale and use of in vitro diagnostic reagents without medical device registration certificate. Most of the external packaging of such in vitro diagnostic reagents only indicate the product name and batch number, and do not indicate information such as medical device registration number, product technical requirements, manufacturer, etc.

2. In vitro diagnostic reagents that fail to change the licensing matters of the medical device registration certificate in accordance with the law. Article 47 of the "Administrative Measures for the Registration of In Vitro Diagnostic Reagents" (General Administration Order No. 5) stipulates that "in vitro diagnostic reagent registration matters include licensing matters and registration matters. Licensing items include product name, packaging specifications, main components, intended use, product technical requirements, product specifications, product expiration date, production address of imported in vitro diagnostic reagents, etc. ......" Article 82 of the Measures stipulates: "Violation of the provisions of these Measures, failure to change the registration permit of in vitro diagnostic reagents in accordance with the law, in accordance with the" Medical Device Supervision and Administration Regulations "on the situation of not obtaining a medical device registration certificate shall be punished."

3. If the medical device registration certificate is not renewed after the expiration of the medical device registration certificate, the old certificate is still used to produce in vitro diagnostic reagents, which should be characterized as in vitro diagnostic reagents that have not obtained the medical device registration certificate, regardless of production, operation or use, in violation of the corresponding regulations.

4. The outer package is not marked with the approval number, but is marked "for research only, not for clinical diagnosis", which should be investigated and dealt with according to the in vitro diagnostic reagent that has not obtained the medical device registration certificate.

Article 15 of the abolished "Administrative Measures for the Registration of In Vitro Diagnostic Reagents (Trial)" stipulates: "Products that are only used for research and not for clinical diagnosis do not need to apply for registration, but their instructions and packaging labels must be marked with the words" Only for research, not for clinical diagnosis." Some criminals use this provision to produce in vitro diagnostic reagents that are not registered, and only mark the words "for research only, not for clinical diagnosis" on the packaging box. This unregistered reagent is sold to secondary or even tertiary medical institutions for clinical use.

On March 13, 2014, the State Administration's "Notice on Printing and Distributing the Special Action Plan for the" Five Rectification "of Medical Devices" clarified that the punishment basis for the use of unlicensed products is: "Medical institutions that use unlicensed in vitro diagnostic reagents shall be punished in accordance with the" Medical Devices ". Article 42 of the Regulations on Supervision and Administration shall be punished and notified to the health authorities at the same level." The "Regulations on the Supervision and Administration of Medical Devices" referred to in this article are the regulations before the revision. Article 42 of the regulations is the penalty clause without a product registration certificate, which is equivalent to the new "Regulations on the Supervision and Administration of Medical Devices" Article 66 Paragraph 3.

2. the production, sale or gift, use of calibration products, quality control products without product registration certificate.

Article 19 of the "Administrative Measures for the Registration of In Vitro Diagnostic Reagents" stipulates: "Calibrators and quality control materials may be combined with in vitro diagnostic reagents used in conjunction to apply for registration, or they may apply for registration separately. Calibrators and quality control products used in conjunction with Class I in vitro diagnostic reagents shall be registered as Class II products; when calibrators and quality control products used in conjunction with Class II and Class III in vitro diagnostic reagents apply for registration separately, they shall be registered in the same category as the reagents; multiple calibrators and quality control products shall be registered according to the high category." It can be seen that the standard products and quality control products used in in vitro diagnostic instruments are also managed according to medical devices and need to be registered.

In reality, a small number of manufacturers have only obtained the product registration certificate of the inspection reagent, and have not obtained the product registration certificate of the calibrator or quality control product.

3. in vitro diagnostic reagents for use with mismatched diagnostic instruments

Some medical institutions in the purchase of imported diagnostic equipment, due to the use of imported diagnostic equipment supporting in vitro diagnostic reagents are very expensive, they tend to purchase domestic cheap similar in vitro diagnostic reagents to replace imported in vitro diagnostic reagents.

In some cases, domestic in vitro diagnostic reagents of similar varieties cannot match imported diagnostic instruments, and such use cannot guarantee the accuracy of test data.

4. changed qualitative detection to quantitative detection without authorization

Some in vitro diagnostic reagents are only approved as qualitative detection reagents at the time of approval. Such as hepatitis B virus detection kit, in addition to surface antigen and serum DNA quantitative detection has clinical significance, the clinical significance of quantitative detection of other indicators is less than the research significance, so hepatitis B virus detection kit in addition to surface antigen, other such as hepatitis B virus core antigen detection kit approved as a quantitative kit is unlikely.

However, due to the fact that quantitative testing charges much higher than qualitative testing in clinical testing, some manufacturers have changed qualitative kits to quantitative kits without obtaining the approval of quantitative testing kits.

5. use of expired in vitro diagnostic reagents

Some in vitro diagnostic reagents are not valid for a long time, even only a few months or half a year. If the clinical use of such reagents is not large, it is easy to appear expired failure. Coupled with the loose management of some medical institutions, leading to expired in vitro diagnostic reagents for clinical use. The use of such diagnostic reagents for testing is clearly unsafe and is highly likely to lead to clinical misdiagnosis and, in turn, to erroneous treatment.

6. unlicensed operation of in vitro diagnostic reagents

In vitro diagnostic reagents are not only managed by drugs, but also managed by medical devices. In vitro diagnostic reagents managed by medical devices are divided into Class I, Class II, and Class III medical devices. The operation of drugs requires a "Drug Business License"; the operation of Class I medical devices does not require any formalities, the operation of Class II medical devices should be filed, and the operation of Class III medical devices must apply for a "Medical Device Business License." It can be seen that the operation of in vitro diagnostic reagents with different management requirements should be licensed or filed in accordance with the corresponding requirements.

Due to the great changes in the management policy of in vitro diagnostic reagents, some enterprises have not fully realized these changes, resulting in the above-mentioned violations of laws and regulations.

7. in vitro diagnostic reagent cold chain can not be guaranteed

Many in vitro diagnostic reagents are biological reagents, and there are strict requirements for their production, transportation and storage. At present, the hardware facilities of cold chain logistics are insufficient, the degree of marketization is low, and the transportation cost is high, and the delivery of in vitro diagnostic reagents is scattered and less. At present, there are not many in vitro diagnostic reagents transported by cold chain vehicles. Most in vitro diagnostic reagents use foam boxes and ice packs to control the temperature during reagent transportation. This mode of transportation cannot fully meet the requirements of in vitro diagnostic reagents for cold storage.
Article 67 of the Regulations on the Supervision and Administration of Medical Devices (Order No. 650 of the State Council) stipulates: "Under any of the following circumstances, the food and drug regulatory department of the people's government at or above the county level shall order corrections and impose a fine of 10000 yuan to 30000 yuan. Fines; if the circumstances are serious, they shall be ordered to suspend production and business, until the original license issuing department revokes the medical device production license and the medical device business license... (III) the medical device is not transported and stored in accordance with the requirements of the medical device instructions and labels..." In addition, Article 60 of the Measures for the Supervision and Administration of Medical Device Business (General Administration Order No. 8) also makes corresponding provisions: "In any of the following circumstances, the food and drug regulatory department at or above the county level shall order it to make corrections, and in accordance with the" medical device supervision and management regulations, "the provisions of article sixty-seventh shall be punished ...... (II) not in accordance with the medical device instructions and labeling requirements of transport, storage of medical devices."