I am a medical device manufacturer with production license and medical device registration certificate. Do you need a business license to sell products to hospitals and distributors?

First of all, let's talk about the classification of medical device enterprises: medical devices are divided into production enterprises and operating enterprises, among which operating enterprises are divided into general agents of imported products and domestic general operating enterprises; If a production enterprise only sells its own products (complete documents), it can see the following rules and regulations without a business license. The domestic general agent (only one) operating imported equipment only needs to apply for a business license, but the import documents must be complete, but the domestic sales can only issue domestic certificates; General commercial enterprises must apply for the license of the products you want to operate.

If you only buy your own products, you don't need a business license!

"Regulations on the Supervision and Administration of Medical Devices" Article 26 Medical device trading enterprises and medical institutions shall purchase qualified medical devices from the manufacturing enterprises that have obtained the Medical Device Manufacturing Enterprise License or the operating enterprises that have obtained the Medical Device Trading Enterprise License, and verify the product certificate.

This also means that as long as the production enterprise has a production license, it does not have to have a business license.

In addition, the OrderNo. of the State Food and Drug Administration of the United States 15 "Administrative Measures for Licenses of Medical Device Enterprises" came into effect on June 25th, 2004. Administrative Measures Article 11 The following materials shall be submitted when applying for the Medical Device Business License: (2) the pre-approval certificate of the enterprise name issued by the administrative department for industry and commerce;

According to the regulations, after a manufacturing enterprise obtains a medical device manufacturing enterprise license in a certain province, it can no longer apply for a medical device operating enterprise license with the same enterprise name in the same province; Refer to Decree No.2004. 15 article 11, paragraph 2, the administration for industry and commerce will not allow enterprises with the same name in the same industry to register twice, so after obtaining the production enterprise license, enterprises cannot apply for a business enterprise license with the same enterprise name. So even if you want to get a business license, you can't.

You need a business license if you want to deal in products that are not produced by yourself.