There is no need to apply for a license to run a class. As long as you have a business license, you can operate without a quality manager. Just like doing business with a company.

First of all, there is no need to apply for a business license to operate a class of medical devices.

Secondly, there is no need to operate some second-class equipment.

The directory is as follows:

Notice on the publication of the first batch of second-class medical device products that do not need to apply for the License for Medical Device Business Enterprises

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All other second-class and third-class medical devices need to apply for medical device business licenses.

How to confirm what kind of medical devices you operate;

Look at the medical device registration number:

The registration numbers are arranged as follows:

* (*)1(food) medical instrument (* 2) No.3. ××××××× 5×××××× 6, in which:

× 1 is the abbreviation of the location of the registration examination and approval department:

Class III medical devices in China, overseas medical devices and medical devices from Taiwan Province, Hongkong and Macau are designated as "China";

The second category of medical devices in China refers to the provinces, autonomous regions and municipalities directly under the central government where the registration examination and approval departments are located;

The first category of medical devices in China is the abbreviation of the province, autonomous region and municipality directly under the central government where the registration examination and approval department is located, plus the abbreviation of the municipal administrative region, which is ×× 1 (if there is no corresponding municipal administrative region with districts, it is only the abbreviation of the province, autonomous region and municipality directly under the central government);

×2 is the registration form (approval, entry and permission):

The word "quasi" is suitable for domestic medical devices;

The word "gold" is applicable to overseas medical devices;

The word "Xu" is applicable to medical devices in Taiwan Province Province, Hongkong and Macau.

××××× 3 is the year of registration approval;

×4 is the product management category;

××5 is the product variety code;

××××× 6 is the registration serial number.

@ US Food and Drug Administration (quasi) word (&; &&No.(★)(##) 1234

(★) What kind of medical equipment does the number in this position represent?