Three types of medical equipment business premises conditions

Three types of medical equipment business premises conditions should have with the scale of operation of the business premises and warehouses. 1. Intervention equipment products, the business premises using an area of not less than 100 square meters, the use of warehouses using an area of not less than 40 square meters; 2, the operation of medical polymer materials and products, the use of the business premises using an area of not less than 60 square meters, warehouse using an area of not less than 80 square meters; 3, the retail business, there should be an independent counter; which provides fitting services, the business premises using an area of not less than 30 square meters. Square meters; 3, the retail business, there should be an independent counter; which provides fitting services, the business premises shall not be less than 30 square meters.

Legal basis "supervision and management of medical devices business approach" Article VII engaged in the operation of medical devices, should have the following conditions:

(a) with the scope and scale of operation of the quality management organization or quality management personnel, quality management personnel should have a state-recognized professional qualifications or titles;

(b) with the scope and scale of business operations and operations of the appropriate Business, storage space;

(C) with the business scope and scale of operation of the storage conditions, all entrusted to other medical device business enterprises can not set up storage;

(D) with the operation of medical devices appropriate quality management system;

(E) with the operation of medical devices appropriate professional guidance, technical training and after-sales service capacity, or Agree to provide technical support by the relevant organizations.

engaged in the third class of medical devices business enterprises should also have to meet the requirements of quality management of medical equipment business computer information management system to ensure that the operation of the product can be traced. Encouraged to engage in the first class, the second class of medical devices business enterprises to establish a quality management of medical equipment business in line with the requirements of the computer information management system.