A medical device enterprise qualification level how to fill
The State Food and Drug Administration on the classification and management of medical devices,*** is divided into three categories: the first category refers to the routine management is sufficient to ensure the safety and effectiveness of medical devices. The second category refers to its safety, effectiveness should be controlled medical devices. Class III refers to, implanted in the human body; used to support, maintain life; potentially dangerous to the human body, its safety, effectiveness must be strictly controlled medical devices. Class I and part of Class II medical devices, as long as the business license business scope of medical devices can operate. Part of Class II and all Class III medical devices, need to apply for a medical device license to operate. Therefore, the enterprise has which class of medical devices business license, fill in which class.Two, a class of medical devices, two or three types of approval requirements of the difference
For a class of requirements: (1) Personnel requirements: the operation of Class F product quality management personnel should have a college (including) or above, or more than junior title, specializing in medical devices, clinical medicine, nursing, biomedical engineering, polymer, Pharmacy, computers, machinery, electronics, engineering, physics and so on. Approval method: check the quality management personnel (1) education or title. (2) office area requirements: business premises area (office area) should be not less than 40 square meters; operation of F products of pharmaceutical retailers should have a relatively independent business premises (area) appropriate to the scale of operation Approval method: check the actual area of the premises (not less than 40 square meters) (3) warehouse area requirements: the use of enterprise warehouses area should be Not less than 20 square meters; The operation of medical equipment stores, drug retailers and only the following categories of code products can be operated without a warehouse: 6824, 6825, 6828, 6830, 6832, 6833, 6870. Approval method: check the actual area of the warehouse (not less than 20 square meters) Requirements for the second and third class Business Two or three types of medical devices, and according to the different business projects are divided into A, B, C, D, E four kinds of cases Here is only the introduction of Class A and Class B Class A can be operated III-6846 implantable materials and artificial organs, III-6877 interventional devices: (1) Personnel Requirements: 1 business A products quality management personnel should have a bachelor's degree (or above) or intermediate or higher title. Above the education or intermediate title, specializing in medical devices, clinical medicine, nursing, biomedical engineering, etc. 2 operating Class A products should be at least two companies engaged in quality management, quality management personnel need to be trained and then on duty. Approval methods: check the quality management personnel (2) education or title; check the list of quality management department personnel; check the quality management personnel related training certificate. (2) office area requirements: the operation of Class A products should be no less than 100 square meters of business premises, business premises rental period of not less than 1 year. Approval methods: check the actual area of the business premises; check the validity of the lease contract. (3) Warehouse Area Requirements: The business of Class A products, the use of corporate warehouse area should be no less than 20 square meters. Approval method: check the actual area of the warehouse. (4) Other requirements: the operation of Class A products, the enterprise warehouse should have cabinets (shelves), with temperature and humidity regulation equipment; operation of Class A products, the enterprise should establish a traceability management system can be reported through the network information, with the ability to trace management through the product number (batch number). Management system should have the following functions: (1) procurement, acceptance management functions; (2) storage management functions; (3) sales management functions; (4) supplier information and product information management functions; (5) other functions in line with the requirements of traceability. Approval methods: check the site, the warehouse should have temperature and humidity regulation equipment; check the product sales records; check the enterprise traceability system. At least including supplier information management, product information management, procurement and quality acceptance data entry query, return management functions, inventory query, expiration date warning function, sales records query and maintenance functions. Class B can operate III-6821 medical electronic instruments and equipment, III-6822 medical optical instruments, instruments and endoscopic equipment, III-6845 extracorporeal circulation and blood processing equipment, III-6854 operating room, emergency room, diagnostic and treatment room equipment and appliances: (1) Personnel Requirements: Business B products quality management personnel should have a college degree (Including) or more education or intermediate title, specializing in medical devices, clinical medicine, nursing, biomedical engineering, electronics, computers and so on. Approval method: check the quality management personnel education or title. (2) office area requirements: the operation of Class B products should be no less than 60 square meters of business premises area. Approval method: check the actual area of the premises. (3) warehouse area requirements: the use of B products in the enterprise warehouse area should be not less than 20 square meters. Approval method: check the actual area of the warehouse. (4) The warehouse area requirement: the business of B products should be less than 20 square meters.