Medical equipment business enterprise license how to handle

Look at how many classes of medical devices you are, each class of requirements are different, the following gives you an example:

Starting a medical device business conditions:

One, the personnel:

1. Class III medical device business enterprise quality full-time management personnel should have college education or intermediate or above title;

2. Class III medical equipment business Enterprises not less than 1 million yuan

3. Class III medical device business enterprise quality inspection personnel should have college education or above, or intermediate or above title; 4. Business involves retailing household therapeutic products or Class III implantable devices should be equipped with certain medical and technical qualifications of personnel.

Two, business premises

1. Business premises: general business use area of not less than 40 square meters, residential buildings can not be used as business premises; retail business enterprises must be front rooms;

2. Warehousing conditions: general business use area of not less than 20 square meters, residential buildings can not be used as a business warehousing premises;

3. One-time use of sterile, implantable and other special medical device products, enterprises must have their own management of the warehouse, warehousing conditions should be in line with the requirements of the provisions of the product standard.

Details can also visit the official website of Freeda.