Sales of medical devices online without certificate? Fine 50000 yuan
From：
Tech Company Date：02-15 275 Belong to：Industry Trends
"Has your company obtained a medical device business license?"
"No."
"What is the 'absorbable surgical suture' that your company sells on Pinduoduo website?"
"It is the third type of medical device, which has a registration number."
A few days ago, the law enforcement personnel of Jinniu District Market Supervision Bureau inspected a trading company located in Zaozi Lane according to the clues and found that the company sold the third type of medical device product "absorbable surgical suture" on the "Pinduoduo" platform.
According to the investigation, the company has not obtained the third type medical device operation license. Since May 20, 2021, it has purchased 212 packages of four types of "absorbable surgical sutures" from a medical device limited company in Chengdu in batches, all of which have been sold on the "Pinduoduo" platform. After verification, the products involved in the case have registration numbers, the value of the goods is 4863.59 yuan, and the illegal income is 835.59 yuan.
The Market Supervision Bureau of Jinniu District believes that the behavior of the parties violates the provisions of Article 42 of the Regulations on the Supervision and Administration of Medical Devices and constitutes an unlicensed online sales of Class III medical devices. According to the provisions of Item (3) of Paragraph 1 of Article 81 of the Regulations on the Supervision and Administration of Medical Devices, the administrative penalty of confiscating the illegal income of 835.59 yuan and imposing a fine of 50000 yuan is imposed.
It is understood that the party concerned has not obtained the business license for the third category of medical devices, which means that the party concerned neither has the quality management organization or quality management personnel suitable for the business scope and business scale, as well as the operation, storage site and storage conditions, nor has the professional guidance, technical training and after-sales service ability suitable for the operation of medical devices, which is difficult to guarantee the product quality.
[Warm reminder from Jinniu District Market Supervision Bureau] Medical device operators must actively apply for medical device business license and implement the requirements of quality management specifications. Those engaged in online sales activities shall display the medical device business license on the website platform, and the product page shall display the medical device registration certificate or filing certificate of the product. Consumers should purchase medical devices from formal channels to protect their legitimate rights and interests. (Written by Zhang Xianting, Yue Yue and Wu Xuesong/photo)
"No."
"What is the 'absorbable surgical suture' that your company sells on Pinduoduo website?"
"It is the third type of medical device, which has a registration number."
A few days ago, the law enforcement personnel of Jinniu District Market Supervision Bureau inspected a trading company located in Zaozi Lane according to the clues and found that the company sold the third type of medical device product "absorbable surgical suture" on the "Pinduoduo" platform.
According to the investigation, the company has not obtained the third type medical device operation license. Since May 20, 2021, it has purchased 212 packages of four types of "absorbable surgical sutures" from a medical device limited company in Chengdu in batches, all of which have been sold on the "Pinduoduo" platform. After verification, the products involved in the case have registration numbers, the value of the goods is 4863.59 yuan, and the illegal income is 835.59 yuan.
The Market Supervision Bureau of Jinniu District believes that the behavior of the parties violates the provisions of Article 42 of the Regulations on the Supervision and Administration of Medical Devices and constitutes an unlicensed online sales of Class III medical devices. According to the provisions of Item (3) of Paragraph 1 of Article 81 of the Regulations on the Supervision and Administration of Medical Devices, the administrative penalty of confiscating the illegal income of 835.59 yuan and imposing a fine of 50000 yuan is imposed.
It is understood that the party concerned has not obtained the business license for the third category of medical devices, which means that the party concerned neither has the quality management organization or quality management personnel suitable for the business scope and business scale, as well as the operation, storage site and storage conditions, nor has the professional guidance, technical training and after-sales service ability suitable for the operation of medical devices, which is difficult to guarantee the product quality.
[Warm reminder from Jinniu District Market Supervision Bureau] Medical device operators must actively apply for medical device business license and implement the requirements of quality management specifications. Those engaged in online sales activities shall display the medical device business license on the website platform, and the product page shall display the medical device registration certificate or filing certificate of the product. Consumers should purchase medical devices from formal channels to protect their legitimate rights and interests. (Written by Zhang Xianting, Yue Yue and Wu Xuesong/photo)
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