The hottest regulation is getting stricter. Semefi

Stricter supervision: saimofei and Dean were heavily fined 800000 for this "small" matter

Abstract: in the storm of investigating and dealing with the production, operation and use of unlicensed medical devices triggered by the Shanghai Drug Administration Department, one after another medical device enterprises were "shot" and given administrative fines, and many fines were still high

in the storm of investigating and dealing with the production, operation and use of unlicensed medical devices set off by the Shanghai Drug Administration Department, one medical device enterprise after another was "shot" and was given administrative fines, and many fines were still high

on June 5, 2017, Shanghai Yangpu District market supervision and Administration Bureau imposed an administrative penalty, and Shanghai Dean medical laboratory Co., Ltd. was fined more than 800000 yuan for using medical devices that were not registered according to law

on May 17 last month, Shanghai Pudong New Area market supervision administration also issued a ticket. Thermo Fisher Technology (China) Co., Ltd. was fined nearly 800000 yuan for operating unregistered medical devices

Thermo Fisher, as we all know, is a foreign-funded giant in the field of IVD. The test kit that led to its punishment also has the reputation of "international gold standard". Shanghai Dean medical testing company, also of good birth, belongs to Dean diagnostics, a domestic IVD leader and A-share listed enterprise

in less than a month, two foreign-funded and domestic well-known IVD enterprises have been fined for the problem of unlicensed medical devices. It is conceivable that the Shanghai Drug Administration Department has made efforts to investigate and deal with the case of unlicensed medical devices, which is also worthy of the vigilance of IVD enterprises in the industry. This is not just pretending to catch small fish, on the contrary, it is really "cutting"

I. The case of Shanghai Dean medical laboratory Co., Ltd. using unregistered medical devices

major violations. The outstanding experimental machines of this kind basically take as the core control components:

this organ filed a case against your unit on July 15, 2016 in accordance with the law. After investigation, your company has the following illegal facts: your company purchased "ab SCIEX triple series quadrupole liquid chromatography-mass spectrometry" in July 2013, and used the above equipment for clinical testing from September 17, 2015 to July 13, 2016. A total of 105 serum samples provided by * * hospital and other units were received, and the vitamin d2d3 test report was issued. Your unit will charge the entrusting unit a testing fee ranging from 35 yuan to 84 yuan per person. The total income is 4419 yuan. According to the appraisal of Shanghai Shenwei Assets Appraisal Co., Ltd., the value of the above instruments is 822500 yuan

neither the above instruments alone nor the whole machine has obtained the medical device registration certificate. According to the classification catalogue of medical devices issued by the State Food and drug administration, the above instruments should be included in the management of class II medical devices

the above facts include your organization code certificate, business license, medical institution practice license, on-site records, photos taken, purchase invoices, purchase contracts, installation acceptance reports, maintenance reports, asset evaluation reports, standard operating procedures for the determination of 25 hydroxyvitamin d2/d3 in serum by liquid chromatography-mass spectrometry, inquiry records, power of attorney, vitamin d2d3 detection and charge list The test report, the collection of medical service items and prices of Shanghai medical institutions, the problem of slipping charges to hospitals, the invoice, the "record of inquiry" to the heads of Shanghai Tianlun hospital, Yangpu District Daqiao community health service center, and the inspection department of Shanghai Zhongda Tumor Hospital, the test report, the qualifications of the above hospitals, the identity documents of relevant personnel, the search results of the database of the State Food and drug administration The evidence such as patent certificate is conclusive

this authority informed you on May 10, 2017 that your unit has the right to hear and make statements and defenses according to law. If your unit fails to make a request for a hearing, statement and defense within the statutory time limit, it shall be deemed to have waived the right to a hearing and statement and defense

your unit is suspected of using medical devices that are not registered according to law, in violation of Article 40 of the regulations on the supervision and administration of medical devices, "medical device operating enterprises and using units shall not operate and use medical devices that are not registered according to law, without qualification certificates, and expired, invalid, or eliminated". According to item (3) of Article 66 of the regulations on the supervision and administration of medical devices "Under any of the following circumstances, the food and Drug Administration of the people's government at or above the county level shall order correction and confiscate the medical devices illegally produced, operated or used; if the value of the medical devices illegally produced, operated or used is less than 10000 yuan, a fine of not less than 20000 yuan but not more than 50000 yuan shall be imposed; if the value of the medical devices is more than 10000 yuan, a fine of not less than 5 times but not more than 10 times the value shall be imposed; if the circumstances are serious, production and business suspension shall be ordered, Until the original license issuing department revokes the medical device registration certificate, medical device production license, and medical device business license: (III) operating and using medical devices that are not qualified, expired, invalid, or eliminated, or using medical devices that are not registered according to law " The first paragraph of Article 4 of the administrative punishment law of the people's Republic of China "administrative punishment shall follow the principles of fairness and openness. The establishment and implementation of administrative punishment must be based on facts, which are equivalent to the facts, nature, circumstances and social harm of illegal acts" According to item (4) of the first paragraph of Article 27 of the administrative punishment law of the people's Republic of China, "if a party has one of the following circumstances, he shall be given a lighter or mitigated administrative punishment according to law: (4) other administrative punishments that are given a lighter or mitigated administrative punishment according to law", this organ orders you to immediately correct the behavior of using medical devices that have not obtained the medical device registration certificate, And decide to impose the following administrative penalties on your unit: a fine of RMB eight hundred and twenty-two thousand five hundred (a fine of one time the value of the goods)

types and methods of punishment: fine (8 is the display of polymer elasticity, 22500 yuan)

basis of administrative punishment: item (3) of Article 66 of the regulations on the supervision and administration of medical devices

II. Thermo Fisher Scientific (China) Co., Ltd. operates the detection kit case of weed pollen mixed with wx5 allergen specific IgE antibody real gold plate that has not obtained the medical device registration certificate when it is used for partition walls

main illegal facts:

after investigation, On August 20, 2015, August 24, 2015 and February 17, 2016, the parties concerned purchased 1035 kits of weed pollen mixed wx5 allergen specific IgE antibody detection kit (fluorescent immunoassay) with batch number of "dn2b3" and production date of September 2014 from Swedish manufacturer phadiaab, at a purchase price of 45 US dollars/box. At that time, the exchange rate of US dollar to RMB was 6.21, so the purchase price was 279.45 yuan/box. Subsequently, the parties concerned sold a total of 525 batches of medical devices involved in the case to 12 dealers at the price of 576.27 yuan/box (excluding tax) and 1 dealer at the price of 658.60 yuan/box (excluding tax) from September 2015 to March 2016

phadiaab, the Swedish manufacturer of the above weed pollen mixed wx5 allergen specific IgE antibody detection kit (fluorescence immunoassay), obtained the medical device registration certificate of the people's Republic of China (Registration Certificate No.: state machinery injection) on February 27, 2015, and the batch of medical devices involved was produced in September 2014, so the manufacturer did not obtain the medical device registration certificate when producing the batch of medical devices involved. The party concerned sold the batch of medical devices involved in the case, which constituted the operation of medical devices that were not registered according to law. By the time the case was filed, the party concerned had recalled 175 boxes of the batch of medical devices involved, so the actual sales quantity was 350 boxes and the inventory quantity was 675 boxes. The total value of the goods in this case is 590923.74 yuan, and the illegal income is 104133.99 yuan

the above facts are composed of on-site records, inquiry (investigation) records, copies of business licenses, copies of medical device business licenses, copies of customs declaration forms for imported goods of the batches of medical devices involved, copies of invoices, copies of sales goods lists, recall reports, copies of medical device registration certificates, screenshots of recall announcement pages, recall record forms The refundable credit certificate list of the recalled products and the proof of collection and other evidences

types and methods of punishment: fine (295461.87 yuan), confiscate illegal income (104133.99 yuan), confiscate illegal property (388982.25 yuan)

basis of administrative punishment: Item 1, paragraph 1, Article 63 of the regulations on the supervision and administration of medical devices