Shenzhen Stock Exchange issued GEM LED industry chain and medical machinery industry information disclosure guidelines
Recently, the Shenzhen Stock Exchange released the information disclosure guidelines for the GEM LED industry chain and the GEM medical device industry . Among them, the medical device guidelines have clearly defined the following disclosure requirements: First, the number and type of medical device registration certificates owned by the company. And clinical use and other information; Second, the company's main medical device production and sales, production and procurement models and sales models; Third, the company's specific business model; Fourth, according to the importance of principles to disclose product development and registration progress; When major product registration certificates, industry policies, etc. have undergone major changes, the company shall promptly announce the relevant information. Previously, the Shenzhen Stock Exchange has issued eight industry guidelines for GEM radio, film and television, biomedicine, photovoltaic, energy conservation and environmental protection, Internet games and Internet video. Attached to the Shenzhen Stock Exchange GEM Board Information Disclosure Guide No. 10 ——Listed companies are engaged in medical device business Article 1 In order to regulate the information disclosure activities of the research and development, production and sales of medical devices listed on the GEM listed companies (hereinafter referred to as “listed companies†or “companiesâ€) of the Shenzhen Stock Exchange (hereinafter referred to as “the Exchangeâ€), the protection Investors' legal rights and interests, according to the "Company Law of the People's Republic of China", "Securities Law of the People's Republic of China", "Administrative Measures for Information Disclosure of Listed Companies" and other laws, administrative regulations, departmental rules, normative documents and "Shenzhen Stock Exchange Board Stock Listing Rules, the Guidelines are formulated. Article 2 A listed company engaged in the research and development, production and sales of medical devices as stipulated in the Regulations on the Supervision and Administration of Medical Devices (Order No. 650 of the State Council) shall perform its information disclosure obligations in accordance with the provisions of these Guidelines. The holding subsidiaries of listed companies are engaged in the research and development, production and sales of medical devices. As the listed companies are engaged in the research and development, production and sales of medical devices, the provisions of these Guidelines are applicable. Article 3 A listed company engaged in medical device business shall fully disclose the research and development, production and sales of medical device projects during the reporting period in accordance with the relevant format standards of the China Securities Regulatory Commission, including at least the following contents: (1) The name, registration classification, clinical use, stage of registration, progress, and whether to declare innovative medical equipment in accordance with the relevant provisions of the State Food and Drug Administration; (2) The medical device name, registration classification, clinical use, and validity period of the registration certificate that have obtained the registration certificate, and indicate whether it is the new registration, change registration or registration certificate invalid during the reporting period; (3) The number of medical device registration certificates at the end of the reporting period and the same period of last year, and the number of new and invalidated documents during the reporting period; (4) The name, production or purchase amount, sales revenue and gross profit margin of the major medical device product categories in the reporting period and the same period last year, which accounted for more than 10% of the company's main business income during the same period last year; (5) The production and procurement modes adopted by the company, as well as the production and purchase amount under different modes; (6) The sales model adopted by the company and the sales revenue and gross profit margin under different modes; (7) The listed company adopts a specific business model, including but not limited to cooperating with the hospital to build large-scale medical equipment , closed-loop sales of in vitro diagnostic reagents and instruments, profit from equipment supply, sales of products while providing financial leasing services, and hospitalization fee sharing. The characteristics of the business model should be specified in detail.
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Attention
1, Medical bone drill is a short-time operation product, each use time of 10 minutes, can not be used continuously for a long time.
2, The battery is strictly prohibited high temperature, high pressure disinfection, after the operation should be taken out of the battery from the medical bone drill, into the packaging box, if not used for a long time, should not be charged and discharged once, so as to avoid plate aging.
3,The charger power cord can not receive oil, chemical solution erosion and mechanical damage.
4, Master the function of the device and the correct installation and use of the method, pay attention to maintenance, only properly maintained, in order to extend the service life, so that expensive medical equipment to use longer.
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