For companies selling masks, goggles, protective clothing, temperature guns and other products, the second class of medical device record certificate and medical device network sales record is a necessary qualification.
A, the second class of medical devices for the record application for processing the materials required:
1, the second class of medical devices business filing application form;
2, a copy of the business license and organization code certificate;
3, legal representative, the person in charge of the enterprise, the person in charge of quality of the identity of the person in charge of the identity card, a copy of the academic qualifications or professional title certificate;
4, Organizational structure and departmental setup;
5, business scope, business mode description;
6, business premises, warehouse address location map, floor plan, documents proving property rights or lease agreement (with documents proving property rights) a copy of;
7, business facilities, equipment directory;
8, business quality management system, working Procedures and other documents directory;
9, the operator's authorization certificate;
10, computer information management system basic information and functional description (encouraging the second class of medical devices business enterprises to establish a computer information management system that meets the requirements of the quality management of medical equipment business, such as this, can be exempted from the description);
11, other evidence (such as the operation of in vitro) Diagnostic reagents, in vitro diagnostic reagents according to the standard requirements to provide medical testing personnel and cold chain facilities and equipment and other additional materials).
Second, the medical device network sales record need to provide the following materials:
1, a copy of the record of Class II medical devices;
2, a copy of the corporate identity card;
3, stationed on the platform of the third-party platform of medical devices record voucher (stationed in the class);
4, the company's store URL;
5, the company's Contact phone email;
Three, individuals selling medical masks to others there are criminal legal risks:
1, individuals will not go to the home to obtain a medical device registration certificate, medical device manufacturing license or medical device license, qualified documents, etc., can not identify whether the medical masks and the quality of qualified, such as sales of shoddy medical masks, in accordance with the provisions of Article 145 of the Penal Code. Article 145 of the Criminal Law, can be convicted and punished for the crime of selling substandard medical equipment.
2, such as hoarding, inflating the price of epidemic prevention and control of urgently needed medical masks and other items, profiteering, in accordance with the provisions of Article 225 (4) of the Criminal Law, criminalized and punished for the crime of illegal business.
3, according to the law to severely punish the crime of making and selling counterfeit. During the epidemic prevention and control, the production of medical masks, goggles, protective clothing and other medical equipment that do not meet the national and industry standards for safeguarding human health, or the sale of medical equipment that is known to be substandard, enough to seriously endanger human health, in accordance with the provisions of Article 145 of the Criminal Law, the crime of production and sale of substandard medical equipment shall be punished by conviction.
4, in accordance with the law to severely punish the crime of price gouging. illegal business crime shall be convicted and punished in accordance with the provisions of the fourth paragraph of Article 225 of the Criminal Law.
Legal basis:
Article 40 of the Regulations for the Supervision and Administration of Medical Devices, engaging in the operation of medical devices, there shall be a place of business and storage conditions appropriate to the scale and scope of operation, as well as the quality management system and quality management institutions or personnel appropriate to the operation of medical devices.
"Supervision and Administration of Medical Devices Regulations" Article 45 medical device business enterprises, the use of units should have legal qualifications from the medical device registrants, filers, production and management of medical equipment purchased from the enterprise. Purchase of medical devices, should check the qualifications of the supplier and medical equipment qualification documents, the establishment of purchase inspection record system. Engaged in the second and third class medical device wholesale business and the third class medical device retail business enterprises, should also establish a sales record system.
Record matters include:
(a) the name, model, specifications, quantity of medical devices;
(b) the production batch number of medical devices, the use of the period or expiration date, the date of sale;
(c) the name of the registrant of the medical device, the filing of the name of the producer and the entrusted production company;
(d) the name of the supplier or purchaser, address and contact information;
(v) the number of relevant licensing documents.
Incoming inspection records and sales records should be true, accurate, complete and traceable, and in accordance with the provisions of the State Council drug supervision and management department to be preserved. The state encourages the use of advanced technical means of recording.