What does the business scope of medical herbal therapy preparations include

Judging from the current domestic regulatory requirements and actual business scenarios, the business scope of compliant medical herbal therapy preparations core covers the sales and supporting services of three major categories of related products approved by the drug regulatory department: mechanical brands, consumer brands, and compliant makeup brands. Shizihao products claiming to be "medical herbs" currently fall within the regulatory red line and must not be included in the relevant business scope.

I have been working as a qualification agent for health care centers and dermatology clinics for almost five years. I have seen too many bosses who have stepped into the trap, and I know the boundaries very clearly. For example, Lao Chen, who runs a community Chinese medicine physiotherapy center, purchased a batch of Class II herbal cold compress gel when it first opened last year. It is specially used for external application of auxiliary analgesia after physical therapy for customers with lumbar protrusion, shoulder and neck pain. At the beginning, he did not include the sale of Class II medical devices in his business scope. Within a week of putting it on the shelves, he was inspected by the city supervisor. He only dared to re-list it after completing the qualifications. This type of herbal preparations that directly act on human wounds and have clear auxiliary therapeutic effects must be approved as medical devices. The corresponding business scope must include categories related to medical devices. Category 1 devices do not require a business license but must be registered in advance. Category 2 and 3 devices must obtain corresponding licenses before they can be operated.

In addition to this kind of products with clear auxiliary treatment properties, many institutions use herbal antibacterial hand sanitizers for customers daily and herbal antibacterial sprays for people with sweaty feet. They are disinfectant products with a small brand name. This type of business scope only needs to include the sale of disinfectant products, and the approval threshold is low. However, it should be noted that even if it is a pure herbal ingredient, you cannot just "treat athlete's foot" or "treat eczema". At most, it can only improve the antibacterial effect, otherwise it will be considered a violation.

Nowadays, many medical beauty institutions and dermatology clinics also sell medical cold compresses and postoperative soothing essences with herbal ingredients. These are either registered devices or functional skin care products with special brand names. The corresponding business scope must include sales of cosmetics and special cosmetics. When I helped a medical beauty clinic apply for qualifications, I specifically reminded them not to use herbal masks with ordinary cosmetic brands as "medical", otherwise they will be particularly vulnerable to professional counterfeiters for claiming compensation.

There is still a controversial point in the industry: can the herbal health products of Shizihao be included in the business scope of medical herbal preparations? To be honest, at least at the current regulatory level, it is not recognized at all. Food brands are ordinary foods. As long as they carry claims such as "medical", "treatment" and "healing", it is considered false advertising. Last year, a customer of an online Douyin store added the words "medical herbal" to the details page when selling herbal stomach tablets. After a complaint, he was fined more than 20,000 yuan, which was not worth the gain. If you are really not sure whether the herbal preparation you want to sell can be included in the business scope, go to the local municipal supervision department with the product registration information in advance and ask for it, which is much more reliable than guessing on your own.