Requirements for a class:
(1) Personnel requirements: the operation of Class F product quality management personnel should have a college (including) or above or above the junior title, specializing in medical devices, clinical medicine, nursing, biomedical engineering, polymers, pharmacy, computers, machinery, electronics, engineering, physics and so on. , engineering, physics, etc.
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) compatible with the scale of operation
Approval method: check the actual area of the business premises (not less than 40 square meters)
(3) warehouse area requirements: Enterprise warehouse area should be no less than 20 square meters;
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.
Methods for approval: check the actual area of the warehouse (no less than 20 square meters)
Requirements for Class II and Class III
The operation of Class II and Class III medical devices, but also according to the operation of the different items are divided into four types of A, B, C, D, E
Here is only the introduction of Class A and B
Class A can be operated in the Ⅲ-6846 implantable materials and artificial organs, Ⅲ-6877 interventional devices:
(1) Personnel Requirements:
(1)Requirements:
The quality management personnel of Class A products are required to be in charge of the quality management of the company's products. Operating Class A product quality management personnel should have a bachelor's degree (or above) or intermediate title or above, specializing in medical devices, clinical medicine, nursing, biomedical engineering, etc. 2 operating Class A products should be at least two people engaged in quality management work, 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: business A product business premises should not be less than 100 square meters, 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 use of A products business warehouse area should be not less than 20 square meters.
Method of approval: check the actual area of the warehouse.
(4) Other requirements: the operation of Class A products should have a warehouse of enterprise cabinets (shelves), with temperature and humidity regulation equipment; operation of Class A products should be established through the network of enterprises to report information on the traceability management system, with the ability to trace through the product number (batch number) for management. 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, purchasing and quality acceptance data entry query, return management functions, inventory query, expiration date warning function, sales record query and maintenance functions.
Category 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: Quality management personnel of the enterprise operating Category B products should be with a college degree (including) or above, or intermediate or above. ) or above or intermediate title, specializing in medical devices, clinical medicine, nursing, biomedical engineering, electronics, computers and so on.
Method of approval: check the quality management personnel education or title.
(2) office area requirements: the operation of Class B products should not be less than 60 square meters of business premises area.
Approval method: check the actual area of the business premises.
(3) Warehouse area requirements: business B products should be no less than 20 square meters of warehouse area.
Method of approval: check the actual area of the warehouse.
So, one, two, three types of medical equipment approval requirements are mainly for personnel, office area, warehouse area is different, if you want to qualification upgrades, according to different standards, different processes re-approval. And the new office is almost the same.