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Seven major violations of in vitro diagnostic reagents
2019-07-15
来源：转载自第三方
The in vitro diagnostic reagent (IVD) involves the whole process of diagnosis, treatment, treatment, treatment evaluation, and therapeutic evaluation. The demand is large, which is related to the vital interests of the people. The State Administration of the People’s Republic of China has successively issued the “Notice on Printing and Distributing the Work Program for In Vitro Diagnostic Reagents”, “Notice on Printing and Distributing the Work Plan for Risk Diagnosis of In Vitro Diagnostic Reagents”, “Notice on Printing and Distributing the Special Rehabilitation Work Protocol for In Vitro Diagnostic Reagents” Documents such as the Notice of Quality Assessment and Integrated Management Work Plan for In Vitro Diagnostic Reagents.
1. In vitro diagnostic reagents for the production, sale and use of medical device registration certificates
In vitro diagnostic reagents that do not have a medical device registration certificate mainly have the following conditions:
(1) The medical device registration certificate has not been obtained, and the in vitro diagnostic reagents have been produced, sold and used. Most of the in vitro diagnostic reagent packagings only indicate the product name and batch number, and do not indicate information such as medical device registration number, product technical requirements, and manufacturer.
(2) In vitro diagnostic reagents that have not been changed according to the license of medical device registration certificate. Article 47 of the “Regulations on the Registration of In Vitro Diagnostic Reagents” (General Order No. 5) stipulates that “the registration of in vitro diagnostic reagents includes licensing items and registration items. The licensing items include product names, packaging specifications, main components, and intended use. , product technical requirements, product specifications, product expiration date, the production address of imported in vitro diagnostic reagents, etc. ..." Article 82 of the Measures stipulates: "In violation of the provisions of these Measures, if the registration of the in vitro diagnostic reagents has not been changed according to law, The Regulations on the Supervision and Administration of Medical Devices shall be punished in cases where the medical device registration certificate has not been obtained."
3. If the in vitro diagnostic reagent is still produced with the old certificate after the medical device registration certificate has expired, it should be characterized as an in vitro diagnostic reagent that has not obtained the medical device registration certificate, regardless of the production, operation or use.
4. The outer packaging does not indicate the approval number, but it is marked as “for research only, not for clinical diagnosis”, and should be investigated according to the in vitro diagnostic reagents that have not obtained the medical device registration certificate.
Article 15 of the revoked “Regulations on 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 must be marked on the instructions and packaging label. Research, not used for clinical diagnosis '. The words used by some lawless elements, the in vitro diagnostic reagents produced are not registered, only the words "for research, not for clinical diagnosis" are marked on the box. This unregistered reagent is sold to secondary or even tertiary care facilities for clinical use.
On March 13, 2014, the Notice of the State Administration of the People's Republic of China on Printing and Distributing the Special Action Plan for Five Remediation of Medical Devices clarified that the punishment for the use of unlicensed products is: “The use of undocumented in vitro diagnostic reagents by medical institutions, in accordance with the medical device Article 42 of the Regulations on Supervision and Administration shall impose penalties and notify the competent health authorities at the same level. The Regulations on the Supervision and Administration of Medical Devices referred to in this Article are the pre-amendment regulations. Article 42 of the Regulations is no product. The penalty clause for the registration certificate is equivalent to the sixth paragraph of Article 66 of the new Regulations on the Supervision and Administration of Medical Devices.
2. Producing, selling or giving away and using calibrators and quality control products without product registration certificate
Article 19 of the “Administrative Measures for the Registration of In Vitro Diagnostic Reagents” stipulates: “The calibrators and quality control products may be combined with the in vitro diagnostic reagents used for registration, or may be separately applied for registration. Calibration with the first type of in vitro diagnostic reagents Products and quality control products are registered according to the second type of products; when the calibrators and quality control products used in combination with the second and third types of in vitro diagnostic reagents are separately applied for registration, they are registered in the same category as the reagents; Calibrators and quality control products are registered according to the high categories. It can be seen that the standards 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 product registration certificates for testing reagents, and have not obtained product registration certificates for calibrators or quality control products.
3. In vitro diagnostic reagents are used in conjunction with mismatched diagnostic instruments
Some medical institutions purchase imported diagnostic instruments, because the use of in vitro diagnostic reagents associated with the imported diagnostic equipment is very expensive, they often purchase domestic cheaper in vitro diagnostic reagents instead of imported in vitro diagnostic reagents.
In some cases, domestically produced in vitro diagnostic reagents of similar varieties are not compatible with imported diagnostic instruments, and such use does not guarantee the accuracy of the test data.
4. Unauthorized conversion of qualitative testing to quantitative testing
Some in vitro diagnostic reagents are only approved as qualitative testing reagents at the time of approval. For example, hepatitis B virus detection kit, in addition to the clinical significance of quantitative detection of surface antigen and serum DNA, the clinical significance of quantitative detection of other indicators is less than the significance of the study, so the hepatitis B virus detection kit in addition to surface antigen, other It is unlikely that a kit such as the Hepatitis B virus core antigen test kit will be approved as a quantification kit.
However, because the cost of quantitative testing is much higher than the qualitative test, some manufacturers have changed the qualitative kit to the quantitative kit without obtaining the approval of the quantitative test kit.
5. Use of in vitro diagnostic reagents that have expired
Some in vitro diagnostic reagents are not long-lived, short or even months or half a year. If such a reagent is not used clinically, it is prone to expiration. In addition, some medical institutions are loosely managed, leading to expired in vitro diagnostic reagents for clinical use. Testing with such diagnostic reagents is clearly unsafe and is highly likely to lead to clinical misdiagnosis, leading to mistreatment.
6. Unlicensed management of in vitro diagnostic reagents
In vitro diagnostic reagents are managed by drugs and managed by medical devices. In vitro diagnostic reagents managed by medical devices are further classified into Class I, Class II, and Class III medical devices. It is necessary to apply for the "Pharmaceutical Business License" for the operation of drugs; there is no need to go through any formalities for the operation of Class I medical devices, and the operation of Class II medical devices should be filed. The operation of Class III medical devices must be handled by the Medical Device Business License. It can be seen that in vitro diagnostic reagents that manage different management requirements should be licensed or filed according to the corresponding requirements.
Due to major changes in the in vitro diagnostic reagent management policy, some companies have not fully realized these changes, and thus the above-mentioned violations.
7. In vitro diagnostic reagent cold chain can not be guaranteed
Many in vitro diagnostic reagents are biological reagents, which have 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, the transportation cost is high, and the in vitro diagnostic reagents are shipped in a small amount, and there are not many in vitro diagnostic reagents that are transported by cold chain vehicles. Most in vitro diagnostic reagents use a foam box with an ice pack to control the temperature during transport of the reagents. Such a transport mode does not fully meet the requirements for in vitro diagnostic reagent refrigeration.
Article 67 of the Regulations on the Supervision and Administration of Medical Devices (No. 650 of the State Council) stipulates: "If one of the following circumstances occurs, the food and drug supervision and administration department of the people's government at or above the county level shall order it to make corrections, and shall be 10,000 yuan or more and 30,000 yuan. The following fines; if the circumstances are serious, the company shall be ordered to suspend production and suspend business until the original license issuing department revokes the medical device production license and the medical device business license. (3) The medical equipment has not been transported and stored in accordance with the medical equipment manual and labeling requirements... ... In addition, Article 60 of the Measures for the Supervision and Administration of Medical Device Operation (Order No. 8 of the General Administration of the State Council) also made corresponding provisions: "In any of the following circumstances, the food and drug supervision and administration department at or above the county level shall order it to make corrections, and Penalties shall be imposed in accordance with the provisions of Article 67 of the Regulations on the Supervision and Administration of Medical Devices... (2) The medical devices are not transported or stored in accordance with the medical device instructions and labeling requirements."
Edited by Suzhou Yacoo Science Co., Ltd.
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