Here, I have compiled a practical skill for handling three types of medical device licenses. Remember to collect it if you need it ~
Class I and Class III medical device license fees
1. The handling fee varies from 30 yuan.
If you apply for a Class III medical device license yourself, there is no charge in this case, and you only need to spend money on preparing materials (materials are printed in 30 yuan, etc. However, it should be noted that if you don't understand it, it is easy to ignore many details, and the cycle may be very long.
The handling fee is about 20000 yuan.
If you apply for three kinds of medical device licenses with the help of a third-party agency, you have to pay a part of the service fee, which is generally around 20,000 yuan. The handling price is not fixed, which is mainly affected by factors such as whether the company meets the requirements, the handling period and the mode of cooperation.
3. Other expenses
In addition to the handling fee, you should also consider the venue fee, equipment fee, personnel fee, etc. It depends on the company's own situation, without which you can't meet the requirements.
Licensing conditions for Class II and III medical devices.
1. Requires the company's business scale to be compatible with the registered capital scale of the enterprise.
, and has equipment, storage facilities and places suitable for its scale, and the area of business premises shall meet the requirements of product use.
2. There should be quality management personnel and corresponding enterprise quality management personnel suitable for the products they operate.
Have professional knowledge and management experience suitable for the business, and be able to operate the products skillfully.
3. Require the enterprise legal person to be the legal representative.
If the enterprise legal person is inconsistent with the actual controller, a valid copy of the business license of the enterprise legal person is also required.
4. Having corresponding business scope,
The business scope of the company shall include medical devices related to the license of Class III medical devices, such as heart stents, syringes, ventilators and CT.
5. Have a clear management system,
The list of executors, inspectors and technical leaders has been implemented, with corresponding post responsibilities, and the records and quality assurance system specifications have been established and effectively implemented to ensure that these systems can be effectively implemented.
Three, for three types of medical device license processing channels
There are two channels for the company to apply for three types of medical device licenses, as follows.
1. The company can handle it through the offline window.
2. The company looks for a third party to handle it. Generally, many companies will choose a third-party organization, which can be handled at one time without wasting time.
The above is the whole content of the "three types of medical device license handling"