How to establish a medical equipment company

The process of registering a medical device company is basically no different from that of general company registration. First of all, we must determine the registered capital, business scope, company name, registered address, investment ratio, etc. , and then approve the company name. After approval, you can bring the corresponding application materials and submit them together with the application (online submission or on-site window submission). The process of registering a medical device company is basically no different from that of general company registration. First of all, we must determine the registered capital, business scope, company name, registered address, investment ratio, etc. , and then approve the company name. After approval, you can bring the corresponding application materials and submit them together with the application (online submission or on-site window submission). After approval, you can get a business license. Finally, it is to handle matters such as engraving, opening an account, applying for invoices, and verifying taxes.

After the medical device company is registered, it needs to do one more thing if it wants to operate normally-apply for a license.

According to the different types of licenses, the conditions to be met are also different. For example, to apply for a Medical Device Business License, the following conditions shall be met at the same time:

1. There are two quality management institutions or quality management personnel with college education or above that are suitable for the scale and scope of business. Quality management personnel should have relevant professional qualifications or titles recognized by the state.

2. It has a relatively independent business place suitable for its business scale and business scope.

3. Having storage conditions suitable for the business scale and scope, including storage facilities and equipment conforming to the characteristics of medical devices.

4. We should establish and improve the product quality management system, including procurement, incoming inspection, warehousing, outbound review, quality tracking system and adverse event reporting system.

5. It shall have the technical training and after-sales service ability suitable for the medical device products it deals in, or agree to provide technical support by a third party.

The establishment of the second and third types of medical device enterprises shall apply to the food and drug administration branch where they operate, and submit the following materials:

(1) "Shenzhen Medical Device Business License Application Form";

(2) Registration Form of Application Materials for Medical Device Business Enterprise License;

(3) A copy of the enterprise name pre-approval certificate or business license issued by the administrative department for industry and commerce (original inspection);

(4) The ID card, certificate of education or professional title and a copy of the resume of the person in charge of quality management of the proposed enterprise;

(5) A copy of the ID card, education or professional title certificate of the quality management personnel of the enterprise to be established;

(six) the organization and functions of the enterprise to be established or the functions of full-time quality management personnel;

(7) A copy of the geographical location map, floor plan (indicating the area), house property right certificate or lease agreement (attached with the leased house property right certificate, the same below) of the registered place and warehouse of the proposed enterprise;

(8) Product quality management system documents and storage facilities and equipment catalogue of the proposed enterprise.