Business scope of medical herbal therapy preparations

The current business scope of domestically compliant medical herbal therapy preparations mainly covers the three core sectors of "production/distribution of herbal medical preparations under the brand name", "production and sales of herbal disinfection/bacteriostatic preparations under the Xiaoxiao brand" and "in-hospital use/commissioned production of herbal preparations in medical institutions". All business operations must strictly comply with the regulatory requirements of the "Medical Device Supervision and Administration Regulations", "Disinfection Management Measures", and "Medical Institution Preparation Registration Management Measures". Operations that exceed the scope may be fined up to 20 times the value of the goods, and in serious cases, criminal liability will be pursued.

Last month, when I was helping the owner of a herbal moxibustion patch maker in Hangzhou's Qiantang District review the business scope materials, he blindly filled in the "production of traditional Chinese medicine preparations" and was almost rejected directly by the city supervisory window. To put it bluntly, he didn't understand the category boundaries - his product is a type of cold compress patch with added moxa leaves and dried ginger extracts. It belongs to the category of medical herbal therapy preparations, and can only be filled in with "Production of Class 1 Medical Devices" and "Sales of Class 1 Medical Devices". If it were really calculated according to the "Production of Traditional Chinese Medicine Preparations" he filled in, he would have to obtain a Chinese Medicine Approval from the State Food and Drug Administration. His small factory could not meet the threshold at all, and he was just looking for trouble for himself. If it is a herbal repair dressing for Class II instruments used for medical and art purposes, additional Class II instrument production/operation registration must be completed, and the business scope must also include the corresponding Class II instrument related categories, otherwise it will not even be eligible to enter the e-commerce platform.

Speaking of category boundaries, there is still a controversy that has been raging for almost two years in the industry: Are makeup and skin care products containing herbal active ingredients considered medical herbal therapy preparations? Practitioners of medical beauty institutions are mostly on the same side, saying that the ingredients of centella asiatica and purslane added to many mechanical-brand medical beauty dressings are almost the same as the raw materials and proportions of herbal repair essences from cosmetic brands. They are all used for soothing after medical beauty treatments and should be included in the same category of management, and the business scope can also be declared in a unified manner. However, the attitude of the regulatory authorities has always been clear: as long as the formal approval of medical/disinfection/hospital preparations is not obtained, no matter how many medicinal-grade herbal ingredients are added, they are just ordinary cosmetics and cannot be regarded as medical products. The business scope cannot be marked with the related categories of "medical herbal preparations", and the words "treatment" and "medical healing" cannot be mentioned when promoting. Otherwise, it will be considered as false advertising and will be fined at least 20,000.

When I visited grassroots stores before, I saw too many owners of physical therapy centers and bone-setting shops falling into this trap. For example, if the herbal hot compress packs and herbal antibacterial sprays sold in your store are sold under the brand name "Disinfection Products", then "disinfection product sales" must be added to the business scope before they can be sold. ； If you want to use your own herbal whiplash cream for customers, then the public clinic/health center you cooperate with must have obtained the approval for the corresponding in-hospital preparation, and it can only be used by customers in the registered business premises. It must not be sold to outsiders through takeaway or WeChat Moments. Last year, there was an bone-setting clinic owner in Huadu, Guangzhou. He made more than 200 boxes of herbal bone-setting ointment and sold it on Meituan. The total value was just over 3,000. In the end, he was fined 60,000 for operating outside the scope and without approval for preparations. The gain outweighed the loss.

Oh, yes, there is another category that is easily overlooked, which is the trade of medical herbal raw materials. If you supply raw materials such as processed medical-grade mugwort, Panax notoginseng, and saffron to a pharmaceutical factory, you must add "purchasing of traditional Chinese medicinal materials" and "wholesale of traditional Chinese medicine pieces" in your business scope. Don't use your business qualifications for ordinary agricultural products to supply the raw materials. Nowadays, the traceability of raw materials in pharmaceutical factories is particularly strict. If you do not have complete qualifications, no matter how good the quality of the raw materials is, they will not dare to accept it. If something goes wrong, both parties will be responsible.

I have been working as a compliance consultant on the medical herbal supply chain for three years. I have seen too many bosses greedy for too much when they first entered the industry. I feel that the more complete the business scope, the better, so as to avoid the trouble of adding new items in the future. Really don’t do this. Supervision is now a double check of “business scope + corresponding qualifications”. If you fill in the form of Class II medical device production, but you can’t get the Class II device production license, the first door-to-door inspection will list you as a business abnormality, which will delay things. When you first start, just fill in the items corresponding to the products you have already received the approval for. You can then add items when the approval for new categories comes out. Now it only takes about a week to add items, so it is not troublesome at all.

To put it bluntly, the approval logic of this business scope can be complicated or simple. The core is "what department has approved your product, fill in the corresponding category, and use corresponding words for publicity." Don't play sideways. Nowadays, the supervision of medical products in various places is becoming more and more strict, and stability is better than anything else.