What are the contents and requirements of the business scope of medical herbal therapy preparations?

The compliant distribution/in-hospital retail of herbal preparations in medical institutions that have been registered with the Food and Drug Administration, the wholesale and retail of commercial herbal therapy preparations that have obtained medical/disposal licenses, and the customized herbal therapy preparation preparation services provided by compliant traditional Chinese medicine diagnosis and treatment institutions for visiting patients must meet the three rigid requirements of qualification access, full-link traceability, and publicity and compliance.

When we usually consult on the qualifications of grassroots traditional Chinese medicine clinics, the most common ones we encounter are this kind of pitfalls. Not long ago, I had a friend who runs a community medical clinic. A self-developed herbal cervical vertebra external application pack received good feedback. He wanted to sell it at the front desk as a peripheral product, but he put it on the shelves without registering the trademark cancellation in advance. Just a week after the sale, the city supervisor came to him and asked him to take it off the shelves for rectification. He also fined him a small 20,000 yuan, because he did not understand the boundaries of the business scope.

Just talking about the entry threshold, different types of preparations require completely different qualifications. If you sell medical herbal patches and medical cold compress gels with a Class II device name, you must first obtain a Class II medical device business registration, and you must add "Second Class medical device sales" to your business scope.； If you want to sell in-hospital herbal preparations, only medical institutions with corresponding diagnosis and treatment qualifications can apply. Ordinary pharmacies and health care centers cannot touch it. Previously, the compound herbal eczema cream of a provincial Chinese medicine doctor went viral on the Internet and people asked for it.

There is still a controversial point in the industry that is not completely unified, which is whether many cosmetics and food products under the banner of "medical herbal" can be included in this business scope? One school of thought is that as long as the product claims to have medical-related effects, it must be regulated as a device/drug. Even if ordinary cosmetics and food herbal products are labeled as "medical", they cannot be included in this type of business, otherwise they will be false propaganda. ； Another school of thought believes that if the herbal soothing preparations used by medical aesthetic institutions are supported by clinical data, as long as the registration information and promotional content match, they can also be included within the business scope of the medical aesthetic institution, without the need for separate device name approval. Last year, there was a medical and art aftercare brand in Zhejiang. Its herbal soothing mask was originally registered as a cosmetic. Later, because it promoted "medical-grade repair and relieve postoperative redness," the city supervisor required it to be re-registered as a Class I device. The business scope was also adjusted to the sale of Class I medical devices. This is a typical result of such ambiguity.

There is another small detail that is easily overlooked. If you open an ordinary Chinese medicine clinic, and the herbal foot bath bags and moxibustion bags you prepare yourself are only used by customers who come for diagnosis and treatment, and are not sold separately, then as long as your clinic’s diagnosis and treatment subjects include Chinese medicine and health care. Just close the content, and there is no need to add additional items to the business scope. Just like opening a home-cooked restaurant to cook pickled radish for customers with rice, there is no need to apply for a separate food production license. However, if you want to bottle it and sell it to customers to take away, you must go through the corresponding filing process. The principle is the same.

Finally, I would like to remind you that there is a red line in publicity that is easy to step on. Even if you are selling a completely compliant medical herbal therapy preparation, your promotion must not exceed the scope of application in the approval document. For example, herbal antipyretic patches with a mechanical brand name can only be said to assist cooling, but cannot be said to cure colds and fevers. Otherwise, even if the promotion exceeds the scope, even if the business qualifications are OK, you will be punished.