The cost of medical device license

Doing medical companies, many will face the difficult task of dealing with the three types of medical device license. I think this time a lot of companies will also look for strategies. How much does it cost to apply for a Class III medical device license? The company has to meet what conditions to deal with?

One of the three types of medical equipment license fees

1. Handling costs ranging from 30 yuan

If you are going to go to the three types of medical equipment license, this case is not charged, you only need to spend the money to prepare the information (information printing ranging from 30 yuan). But need to pay attention to, if you do not know yourself, it is easy to ignore many details, the cycle may be very long.

2. The cost is about 20,000 yuan

For the three types of medical device license, if you are looking for a third party agency to help apply for the application, you have to pay a part of the service fee, generally about 20,000 yuan, the price is not fixed, mainly due to the company is not in line with the requirements for the cycle of processing, the mode of cooperation and other factors.

3. Other costs

In addition to the cost of processing, for three types of medical device license should also consider the cost of the site, the cost of equipment, personnel costs, etc., these costs will be the company with its own situation, and without these words you can not meet the conditions for processing.

Two, three types of medical equipment license conditions

1. Requirements for the company's scale of operations and the size of the enterprise's registered capital, and its scale of equipment, warehousing facilities and premises, the area of the premises should be in line with the use of the product requirements.

2. There should be appropriate quality management personnel and the corresponding quality management personnel of the enterprise, with their professional knowledge of the business and management experience, and be able to skillfully operate the products operated.

3. The need for enterprise legal person is the legal representative, the enterprise legal person and the actual controller is not the same, but also need to provide a copy of the valid business license of the enterprise legal person.

4. There is a relevant business scope, the company's business scope should include Class III medical device license related medical devices, such as cardiac stents, syringes, ventilators, CT, etc..

5. There is a clear management system, the implementation of the implementation of the list of executives and inspectors and the technical responsible person, and the corresponding work responsibilities, the establishment and effective implementation of records and quality assurance system specifications to ensure that these systems can be effectively implemented.

Three, for the three types of medical device license channels

The company wants to apply for the three types of medical device license there are two channels, as follows.

1. The company can be processed through the offline window.

2. The company to find a third-party agency to deal with. Generally many companies because they will choose a third-party agency, so that they can be handled at once, will not waste time.