For the same reason, the IVD big-handed match, Mo Fei and Dean were all severely punished!

Release date: 2017-06-07

In the storm of the investigation, production, operation and use of unlicensed medical devices initiated by the Shanghai Drug Administration, one after another medical device companies were successively "shot" and were given administrative fines, and many of the fines were still high.

On June 5, 2017, Shanghai Yangpu District Market Supervision Administration imposed an administrative penalty. Shanghai Dean Medical Laboratory Co., Ltd. was fined more than RMB 800,000 for using medical equipment that was not legally registered.

Just on May 17 last month, Shanghai Pudong New Area Market Supervision Administration also issued a ticket. Thermo Fisher Scientific (China) Co., Ltd. was fined for the operation of medical devices that were not legally registered. Nearly 800,000 yuan.

Thermo Fisher Scientific, as we all know, is a foreign-invested giant in the field of IVD, and its test and test kits that have been punished have the reputation of “international gold standard”. Shanghai Dean Medical Testing Co., Ltd. is also a well-known company, belonging to the domestic IVD leader, A-share listed company Dean Diagnostics.

In less than a month, two foreign-funded and domestically-recognized IVD companies were issued with tickets for undocumented medical devices. The Shanghai drug regulatory department’s investigation of undocumented medical device cases can be imagined and worthwhile. Industry IVD companies are alert. This is not a way of doing things, just catching small fish. On the contrary, it is really "cutting the knife"!

1. Shanghai Dean Medical Laboratory Co., Ltd. uses medical device cases that are not legally registered

Main illegal facts:

This organ has filed an investigation on your unit on July 15, 2016. After investigation, your unit has the following illegal facts: Your unit purchased the “AB SCIEX Triple Quadrupole LC/MS” in July 2013.

The above equipment was used for clinical testing from September 17, 2015 to July 13, 2016. A total of 105 samples of serum samples provided by hospitals and other units were received, and a test report sheet of "Diamond D2\D3" was issued and issued. Your unit will charge the entrusting unit a test fee ranging from 35 yuan to 84 yuan per person. The total income is RMB 4,419. According to Shanghai Shenwei Assets Appraisal Co., Ltd., the value of the above instruments is RMB 822,500.

The above instruments did not obtain a medical device registration certificate either alone or in the whole machine. According to the "Catalogue of Medical Devices" issued by the State Food and Drug Administration, the above instruments should be included in the second category of medical device management.

The above facts include your organization's organization code certificate, business license, medical institution practice license, "live transcript", photographs taken, purchase invoice, purchase contract, installation acceptance report, maintenance report, "asset evaluation report", Standard Practice for Determination of 25-Hydroxyvitamin D2/D3 in Serum by Liquid Chromatography and Mass Spectrometry, "Inquiry Record", Power of Attorney, Vitamin D2\D3 Detection and Charge List, Test Report, and "Shanghai Medical Institutions Medical Care" "Service items and price compilation", invoices to hospitals, "Inquiry Notes", test report, qualifications of the above hospitals, relevant to Shanghai Tianlun Hospital, Yangpu District Bridge Community Health Service Center, Shanghai Zhongda Cancer Hospital The evidence of the identity document of the personnel, the database search results of the State Food and Drug Administration, and the patent certificate are evidenced, and the evidence is conclusive.

This organ shall, according to law, on May 10, 2017, inform your organization of the right to hear and state the defense in accordance with the law. Your unit has not requested a hearing within the statutory time limit, nor has it made a request for a statement or a defense. It is deemed to have waived the hearing and the right to make a statement.

Your unit is suspected of using medical devices that have not been legally registered, in violation of Article 40 of the Regulations on the Supervision and Administration of Medical Devices. "Medical device operating enterprises, users must not operate, use not registered according to law, no certification documents, and expired, invalid, eliminated. The provisions of the medical device. According to Article 66 (3) of the Regulations on the Supervision and Administration of Medical Devices, “one of the following circumstances shall be ordered by the food and drug supervision and administration department of the people's government at or above the county level to correct the medical equipment illegally produced, operated or used. The amount of medical equipment illegally produced, operated or used is less than 10,000 yuan, and is fined not less than 20,000 yuan but not more than 50,000 yuan; the value of goods is more than 10,000 yuan, and the value of goods is more than 5 times 10 times 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 registration certificate, medical device production license, and medical device business license: (3) operating and using non-qualified certification documents, expired, "Invalidation, elimination of medical devices, or use of medical devices that are not legally registered", "Article 1 of the "Administrative Punishment Law of the People's Republic of China", "Administrative Punishment follows the principle of fairness and openness. The establishment and implementation of administrative penalties must be Based on facts, it is equivalent to the facts, nature, plot and social harm of illegal acts." Article 27, paragraph 1 (4) of the Punishment Law “If a party has one of the following circumstances, it shall be lighter or lighter than the administrative punishment according to law: ... (4) Others shall be lighter or less administratively punished according to law” It is stipulated that this organ orders your unit to immediately correct the use of medical devices that have not obtained the medical device registration certificate, and decides to impose the following administrative penalties on your unit: Fines of RMB 捌 贰仟 贰仟 贰仟 ( ( ( ( ( ( ( ( ( ( ( ( ( .

Type and method of punishment: fine (822,500 yuan)

Basis for administrative punishment: Article 66 (3) of the Regulations on the Supervision and Administration of Medical Devices

2. Thermo Fisher Scientific (China) Co., Ltd. operates a weedy pollen mixed WX5 allergen-specific IgE antibody test kit without obtaining a medical device registration certificate.

Main illegal facts:

Upon investigation, the parties purchased the batch number "DN2B3" and the production date of September 2014 from the Swedish manufacturer PhadiaAB on August 20, 2015, August 24, 2015 and February 17, 2016, respectively. Grass pollen mixed WX5 allergen-specific IgE antibody detection kit (fluorescence immunoassay) 1035 boxes, the purchase price of 45 US dollars / box, the exchange rate of the US dollar against the RMB was 6.21, so the purchase price was 279.45 yuan / box. After that, the parties sold them to 12 dealers for the period of RMB 576.27/box (excluding tax) from September 2015 to March 2016, and sold them at RMB 658.60/box (excluding tax). 1 dealer, a total of 525 boxes of medical equipment involved in the case.

The Swedish manufacturer Phadia AB of the above-mentioned 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 on February 27, 2015 (Registration certificate number: National Machinery injection) 20153400781), 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 sale of the batch of medical devices involved by the parties constitutes the operation of medical devices that are not legally registered. By the time the case was filed, the parties had recalled 175 boxes of medical equipment involved, so the actual sales volume was 350 boxes and the inventory quantity was 675 boxes. The total value of the case is 590,923.74 yuan, and the illegal income is 104,133.99 yuan.

The above facts, from the on-site transcript, inquiry (investigation) transcript, business license copy, medical device business license copy, the batch of medical equipment customs customs import goods declaration copy, invoice copy, copy of the goods list, recall A copy of the report, a copy of the medical device registration certificate, a screenshot of the recall notice page, a recall record form, a recalled product refundable credit certificate list, and a receipt certificate.

Types and methods of punishment: fine (295,461.87 yuan), confiscation of illegal income (104,133.99 yuan), confiscation of illegal property (388,982.25 yuan)

Basis for administrative punishment: Article 63(1)(1) of the Regulations on the Supervision and Administration of Medical Devices

Source: Cypress Blue Instruments (Micro Signal medchina)

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