Can the medical website on May 26th remember the case of the reagent?
Last may, according to the China youth daily, Beijing, Shanghai, nanjing and other places of many famous hospitals, research institutes will be supposed to "is only for study" unregistered medical equipment, used for clinical diagnosis. Those medical devices are the game's fly Phadia allergen diagnosis reagent products of the company, a well-known public 3 armour hospital and Beijing also for alleged use the unregistered reagent, Beijing by the agency to initiate an investigation.
May 17, 2017, Shanghai pudong market regulatory authority also issued a "Shanghai food drug safety (pu) in the word [2016] no. 2220160037" on the administrative penalty, the game's fly the world's science and technology (China) co., LTD. For running unlicensed Phadia reagent was accumulated FaMeiKuan nearly 800000 yuan.
The ticket could be seen as a public response to the controversy over the reagent of symer-fei Phadia in Shanghai.
And the same is for unlicensed medical instrument this behavior, the agency in Shanghai in April and offer three high ticket, there are 3 companies were FaMeiKuan about 430000 yuan, 210000 yuan and 540000 yuan.
The four big fines have appeared, showing that the regulator is upgrading the regulatory enforcement of unlicensed medical devices.
Here are four details of the case:
The case of symerfly technology (China) co., LTD
The main illegal facts:
After the check, the parties concerned respectively on August 20, 2015, on August 24, 2015, and on February 17, 2016 points from Swedish manufacturer PhadiaAB purchase batch number for three times "DN2B3", the production date for September 2014 weeds class mixed WX5 pollen allergen specific IgE antibody detection kit (fluorescence immunoassay) 1035 boxes, purchase price $45 / box, the dollar/yuan rate is 6.21, so pleased to 279.45 yuan/box.
Later, the parties in September 2015 to March 2016, respectively, for the price of 576.27 yuan/box (excluding tax) sold to 12 dealer, for the price of 658.60 yuan/box (excluding tax) sell to a dealer, a total of 525 boxes of batches involved medical equipment sales.
The weeds class mixed WX5 pollen allergen specific IgE antibody detection kit (fluorescence immunoassay method) Swedish manufacturer PhadiaAB in February 27, 2015, the People's Republic of China medical device registration certificate (certificate number: the machinery into 20153400781), in the case of medical apparatus and instruments in September 2014 the production batch, therefore, the medical device manufacturers involved in the production batch has not obtained the medical device registration certificate. The parties involved in the sale of the medical instruments involved in the sale of the medical instruments in the case constitute a medical device that is not registered in accordance with the law.
By the time of the case, the client had recalled 175 boxes of the medical instruments involved in the case, so the actual sales volume was 350 boxes, and the inventory was 675 boxes. The total value of the case was 590923.74 yuan, and the illegal income was 104,133.99 yuan.
The records of all these facts, the scene, asking the records (survey), photocopy of business license copy, medical equipment business licenses, medical apparatus and instruments involved in batch copy, copy of invoice and customs declaration forms of import cargo sales invoice copy, recall report, medical device registration certificate copy, to recall page screenshots, recalled printout form, recalled products should be refund credit list and proof of payment and other evidence.
Relevant administrative penalty:
In accordance with the regulations on the supervision and administration of medical devices (the first of the first paragraph of article sixty-three (1), shall be fined RMB 295461.87, confiscate the illegal income 104133.99 yuan, confiscate the illegal property 388982.25 yuan.
The name of the organ that shall be punished:
Shanghai pudong new area market supervision and administration bureau
The date of decision making:
May 17, 2017
Shanghai xinhua medical development co., LTD
The main illegal facts:
The operating pressure of the second category of medical devices without registration antithrombotic take actions in violation of the regulations on the supervision and administration of medical devices the provisions of article 40 constitute the management of medical device registration certificate against the illegal facts of the second category of medical devices.
Relevant administrative penalty:
According to the first paragraph (1) of article 63 of the regulations on the supervision and administration of medical devices, the illegal income of 334564.46 yuan was confiscated by the confiscation of the illegal income of 96266.73 yuan.
The name of the organ that shall be punished:
Shanghai fengxian district market supervision bureau
The date of decision making:
April 18, 2017
Shanghai shu mai medical instruments co., LTD
The main illegal facts:
Client management has not obtained the pressure of the medical device registration certificate antithrombotic take actions in violation of the regulations on the supervision and administration of medical devices the provisions of article 40 constitute the management of medical device registration certificate against the illegal facts of the second category of medical devices.
Relevant administrative penalty:
According to the law of the People's Republic of China on administrative punishment law article 23, regulations on the supervision and administration of medical devices, the first of the first paragraph of article sixty-three (1), shall confiscate the illegal income 125739.32 yuan, confiscate the illegal property 80364 yuan.
The name of the organ that shall be punished:
Shanghai fengxian district market supervision bureau
The date of decision making:
April 05, 2017
Four, Shanghai weile medical supplies technology co., LTD
The main illegal facts:
The operating pressure of the second category of medical devices without registration antithrombotic take actions in violation of the regulations on the supervision and administration of medical devices the provisions of article 40 constitute the management of medical device registration certificate against the illegal facts of the second category of medical devices.
Relevant administrative penalty:
According to the first paragraph (1) of article 63 of the regulations on the supervision and administration of medical devices, the illegal income of 36,100 yuan shall be confiscated, and the illegal property shall be confiscated 203,080 yuan.
The name of the organ that shall be punished:
Shanghai fengxian district market supervision bureau
The date of decision making:
April 05, 2017 |
