A few years ago, the Danyang Municipal Market Supervision and Administration Bureau concluded a case in which an operating enterprise engaged in the wholesale business of medical devices sold three types of medical devices to an unqualified operating enterprise.
On July 9, 2021, the bureau received the "Case Lead Submission Letter" from the Zhenjiang Municipal Market Supervision and Administration Bureau, which pointed out that a Shanghai eyewear enterprise operated Class III medical devices without permission, and its supplier was a Danyang Optical Glasses Co., Ltd. The bureau found out through the filing of the case that a certain optical glasses company in Danyang was established in 2008, holding the "Medical Device Business License", and engaged in the wholesale business of three types of medical devices: 6822 contact lenses (flexible) and nursing fluids. In July 2020, during the sale of MISEELOOK brand soft hydrophilic contact lenses to a Shanghai eyewear company, a Shanghai eyewear company had its business license revoked by the Shanghai Fengxian District Market Supervision and Administration Bureau on June 1, 2020, and it has been cancelled.
The bureau believes that as an enterprise engaged in the wholesale business of the third type of medical devices, a certain optical glasses co., LTD. in Danyang should wholesale and sell medical devices to legitimate buyers, and should verify the buyer's certification documents and business scope before sales, establish a buyer's file, and ensure that the sales of medical devices flow to be true and legal. The company wholesaled Class III medical devices to market entities that have had their business licenses revoked or cancelled, apparently failing to properly perform the above obligations. Even if the parties have understood the relevant qualifications of the purchaser, but fail to verify the buyer's certification documents and business scope, their behavior violates the provisions of Article 47, Paragraph 2 of the Good Management Specification for Medical Device Business, Article 37 of the Measures for the Supervision and Administration of Medical Device Business, and in accordance with the provisions of Article 54 (3) of the Measures for the Supervision and Administration of Medical Device Business, the company is ordered to immediately correct the illegal behavior and fined 10,000 yuan.
Danyang Municipal Market Supervision and Administration Bureau is telling the majority of market players that the glasses industry is the first image industry in Danyang, and industry practitioners should earnestly fulfill their main responsibilities, maintain the brand reputation of Danyang glasses, and carry out business activities in accordance with laws and regulations. It also reminds consumers that contact lenses and contact lens care solutions are products that directly contact the cornea of the human body and belong to the third class of medical devices strictly controlled and managed by the state. Consumers must go to a regular merchant holding a "Medical Device Business License" to buy contact lenses, and check whether the product is marked with a label such as the medical device product registration certificate number. If illegal operations and other behaviors are found, you can call the 12315, 12345 hotlines to make complaints and reports, and the market supervision and management department will seriously investigate and deal with them according to law.
Source: Danyang Market Supervision