Seven Major Violations of In Vitro Diagnostic Reagents (IVD)

Issuing time:2018-10-23 00:00

In vitro diagnostic reagents ( IVD) are involved in the whole process of diagnosis and treatment of diseases, such as diagnosis, treatment scheme selection, evaluation of curative effect, etc. The demand is great, and it is related to the vital interests of the people. The General Administration of China has issued the Notice on Issuing the Work Plan for the Sampling Test of In Vitro Diagnostic Reagents, the Notice on Issuing the Risk Screening Work Plan for In Vitro Diagnostic Reagents, the Notice of the General Office of the State Administration on Issuing the Work Plan for Quality Evaluation and Comprehensive Treatment of Reagents.

一、

Production, sale and use of in vitro diagnostic reagents without medical device registration certificate

In vitro diagnostic reagents that do not have a medical device registration certificate are mainly in the following situations:

Production, sale and use of in vitro diagnostic reagents without medical device registration certificate.Such in vitro diagnostic reagents are mostly labeled with product name and batch number, not such as medical device registration number, product technical requirements,manufacturers and other information.

In vitro diagnostic reagents that fail to change the registration license of medical devices according to law.Article 47 of the measures for the administration of registration of in vitro diagnostic reagents (Decree No. 5 of the General Administration of Taxation) stipulates that "registration of in vitro diagnostic reagents includes licensing matters and registration matters"item.Licensing items include product name, packaging specifications, major components, intended use, product technical requirements, product specifications,product validity, the production address of imported in vitro diagnostic reagents, etc ... "Article 82 of the measures stipulates:" Those who violate the provisions of these measures and fail to handle the change of the licensing items for in vitro diagnostic reagents registration according to law,penalties shall be imposed in accordance with the regulations on the supervision and administration of medical devices in the case of failure to obtain a medical device registration certificate."

3. When the medical device registration certificate fails to continue after the expiration of the certificate, an in vitro diagnostic reagent is still produced with the old certificate, which shall be characterized as failing to obtain a medical device registration certificate in vitro diagnostic reagents, regardless of production, operation or use, are in violation of the corresponding regulations.

The outer packaging does not indicate the approval number, but it indicates that "only for research, not for clinical diagnosis", should be investigated according to the in vitro diagnostic reagents without medical device registration certificate.

Article 15 of the measures for the administration of registration of in vitro diagnostic reagents (for Trial Implementation), which has been abolished, stipulates: "Products used for research only and not used for clinical diagnosis do not need to apply for injectionbook, but its instructions and packaging labels must be marked 'only for research, not for clinical diagnosis'." some lawless elements use this article to stipulate that the in vitro diagnostic reagents produced are not registered and are only marked on the box " for research purposes only, not for clinical diagnosis. The unregistered agent is sold to secondary or tertiary care institutions for clinical use.

On March 13, 2014, the notice of the State General Administration of China on printing and Issuing the special action plan for the "five rectification" of medical devices clarified that the penalty basis for using unlicensed products is:"Medical institutions that use unlicensed in vitro diagnostic reagents shall be punished in accordance with Article 42 of the regulations on the supervision and administration of medical devices.They should also notify 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, and Article 42 of the regulations is precisely the penalty clause for not having a product registration certificate.It is equivalent to paragraph 3 of Article 66 of the new regulation on the supervision and administration of medical devices.

二、

Production, sale or donation or use of calibration products and quality control products without product registration certificates

Article 19 of the Measures for the Administration of Registration of Diagnostic Reagents in Vitro provides that: "The calibrator and quality control products may be registered in combination with the in vitro diagnostic reagents used, or may be registered separately. Calibrations and quality control products used in conjunction with Type I In Vitro Diagnostic Reagents shall be registered as Class II products; The calibration products and quality control products used in conjunction with Category II and Category III diagnostic reagents shall be registered in the same categories as the reagents when applying for registration separately.A number of calibration products, quality control products, according to the high category of registration. " Clearly, the standard products and quality control products for 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 test reagents, and have not obtained the product registration certificate of the calibration products or quality control products.

、Use of in vitro diagnostic reagents in combination with mismatched diagnostic instruments

Some medical institutions, after purchasing the imported diagnostic instruments, often purchase cheap home-made in-vitro diagnostic reagents to replace the imported diagnostic reagents because of the high cost of using the in-vitro diagnostic reagents that match the imported diagnostic instruments in the first instance. In the second part of the medical institutions, the IV diagnostic reagents are often purchased in the first place.

In some cases, the in vitro diagnostic reagents of similar varieties made in China could not match the imported diagnostic instruments, so the accuracy of the test data could not be guaranteed.

、Changing Qualitative Tests to Quantitative Ones Without Permission

Some in vitro diagnostic reagents are only approved for qualitative testing when they are approved. Such as hepatitis B virus test kit, in addition to surface antigen and serum DNA quantitative detection of clinical significance, The clinical significance of quantitative detection of other indexes is less than that of research. Therefore, it is unlikely that other HBV test kits, such as HBV core antigen test kits, will be approved as quantitative test kits, with the exception of surface antigen.

However, because the charge of quantitative test is much higher than that of qualitative test, some manufacturers change the qualitative test kit into quantitative test kit without the approval of quantitative test kit in some cases.

Use of in vitro diagnostic reagents that have expired

Some in vitro diagnostic reagents are not very long, or even a few months or six months. If this kind of reagent clinical use quantity is not big, it is easy to have the case of expiration invalidation. In addition, some medical institutions are laxly managed to induce in vitro diagnostic reagents that have expired for clinical use. The use of such diagnostic reagents for examination is obviously not safe and may lead to clinical misdiagnosis, and thus to error treatment.

六、

Unlicensed in vitro diagnostic reagents

In vitro diagnostic reagents are divided into Class I, Class II and Class III according to the management of drugs and medical devices, and Class I, Class II and Class III medical devices, according to the management of medical devices in vitro diagnostic reagents for medical devices. It is necessary to apply for a Pharmaceutical Trading License for Drug Trading; To operate Class I medical devices, there is no need to go through any formalities. To operate Class II medical devices, the Business License for Medical Devices shall be put on record. To operate Class III medical devices, the Business License for Medical Devices shall be handled. Visible, management requirements of different in vitro diagnostic reagents should be licensed or filed according to the corresponding requirements.

Because the policy of in vitro diagnostic reagents has changed a lot, but some enterprises have not fully realized these changes, so the above-mentioned illegal behavior appears.

七、

Seven, in vitro diagnostic reagent cold chain can not be guaranteed

Many in vitro diagnostic reagents are biological reagents, which have strict requirements for the 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 distributed.At present, there are not many in vitro diagnostic reagents transported by cold chain vehicles.Most in vitro diagnostic reagents are packaged in a foam box with an ice pack to control the temperature of the reagent during transport, a mode of transport that does not completely reach the bodyrequirements for Refrigeration of External Diagnostic Reagents.

Article 67 of the regulations on the supervision and administration of medical devices (Decree No. 650 of the State Council) stipulates: "In any of the following circumstances, the food and Drug Administration of the people's government at or above the county level shall be governed bythe supervision and management department shall order it to make corrections, and impose a fine of not less than 10,000 yuan but not more than 30,000 yuan; if the circumstances are serious, it shall be ordered to stop production and business until the original license issuing department shall revoke the medical device production license and medical device operation license ... ( 3 ) failing to transport and store medical devices according to the instructions and labels of medical devices ... " in addition, Article 60 of the Measures for the Supervision and Administration of Medical Device Management ( Order No. 8 of the General Administration ) also stipulates : " In any of the following circumstances, the food and drug regulatory department at or above the county level shall order correction and impose penalties in accordance with Article 67 of the regulations on the supervision and administration of medical devices... Failing to transport or store medical devices in accordance with the requirements of the specifications and labels of medical devices."




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