What does the business scope of medical herbal therapy preparations include

The business scope of medical herbal therapy preparations that we often talk about is stuck in the dual compliance framework of the Food and Drug Administration and Industry and Commerce. The core covers the sales of herbal related preparations that have obtained formal consumer/device/cosmetic/in-hospital preparation registration numbers, the commissioned processing and directed circulation of compliant in-hospital herbal preparations, and the export of supporting medical herbal therapy technology. Other marginal items basically fall under the regulatory red line.

A while ago, I contacted a small factory in Hangzhou that makes herbal external preparations. When he first registered, the boss only wanted to include the sales of ordinary plasters. Later, after listening to the agent's suggestion, he specially added the second-class herbal formula medical cold compress patch, the elimination-brand herbal antibacterial spray, and the processing of in-hospital preparations. Later, he took orders for customized herbal external application kits from three surrounding community hospitals, which fell within the scope of the business and did not get stuck at all.

The most controversial issue in the industry right now is whether the herbal drinks produced by the Shi brand can be included in this business scope. Some practitioners feel that as long as it is clearly used as a supporting conditioning product for medical herbal therapy, it can be released if the industrial and commercial additions are made in advance. However, the general attitude of the regulatory authorities is that the food label is essentially an ordinary food and cannot be linked to the concept of "medical use". It is easy to shoehorn it in. Suspected of false propaganda, the city supervisory windows in more than a dozen cities I visited basically do not recommend classifying herbal products with ordinary food brands into this category. If you really want to make formula products with the same source of medicine and food, it is much safer to go through the registration of special meals or the registration of in-hospital preparations.

Some people may ask, do the herbal moxibustion columns and herbal essential oils used for massage provided to medical institutions and physical therapy centers count? Here are the qualifications: Medical moxibustion equipment and medical-grade herbal essential oils with mechanical brands can be included, but herbal products with ordinary cosmetic brands and daily use are not allowed. Previously, a merchant in Foshan put herbal essential oils from ordinary daily cosmetics lines into this business scope for sale. After complaints from consumers, not only did they make corrections for half a month, but they also paid a fine of nearly 20,000 yuan.

If you really want to register a business scope of this type, it is recommended to read the local "Medical Device Business Supervision and Management Measures" and the local Chinese Medicine Management Regulations in advance, and sort out the qualifications of the products you want to make. Don't wait until the business license is issued only to find that the business you want to do is not within the scope, and you will have to go through several times in vain.