What are the requirements for the business scope of medical herbal therapy preparations

Currently, there is no separate exclusive business scope category for "medical herbal therapy preparations" in China. The business scope of such products is required to fully match their own filing/registration attributes. The core principle is "what batch number of products corresponds to what business qualifications", and cannot be generally covered by vague categories such as "herbal therapy" and "health care services".

I just helped the owner of a community health center in Gongshu District, Hangzhou, to refinish his qualifications last month. He had previously taken it for granted that all he sold were herbal physiotherapy-related products, and it was enough to add "health care services (non-medical)" to his business license. However, market supervision came to conduct a random inspection and found that the three herbal analgesic liniments in his store were all Category II medical devices with batch numbers, and he failed to register for Category II medical devices. He was fined more than 8,000 yuan on the spot and required to make rectifications within a time limit. This was because he failed to understand the properties of the products.

If the herbal preparations you sell are Chinese patent medicines that start with Z, whether they are oral or external ointments, you must first obtain a "Pharmaceutical Business License", and the business scope must be marked with the category "Pharmaceutical Retail" or "Pharmaceutical Wholesale". If herbal physiotherapy products belong to the category of Class II or Class III medical devices, such as common herbal hot compress patches and herbal acupoint pressure stimulation patches, corresponding registration or business license must be obtained according to the level of the device. The business scope must also include the corresponding categories of "Sales of Class II Medical Devices" and "Business of Class III Medical Devices".

Nowadays, there is a lot of discussion in the industry about the situation of traditional Chinese medicine institutions making their own in-hospital herbal preparations. At present, the regulatory standards do vary across regions, and there is no completely unified standard: regulatory authorities in many regions believe that as long as such preparations have obtained regular in-hospital preparation batch numbers in accordance with the "Measures for the Registration and Management of Preparations in Medical Institutions" and are only used within the scope of practice of the institution and are not circulated and sold externally, there is no need for additional in-hospital preparations. If a new business scope is added to the business license, it will be compliant as long as the institution's own scope of practice includes categories related to traditional Chinese medicine; however, market regulatory authorities in some areas require that such preparations provided to patients for a fee are part of the business activities and must be additionally added with the relevant categories of "sales of preparations in medical institutions". Before applying, it is best to confirm with the local health and market regulatory authorities in advance to avoid wasting time.

If you are making Xiaozihao's herbal antibacterial and nursing preparations, which are not for medical purposes, the requirements are much looser. You only need to add "disinfectant supplies sales" to your business scope, and you don't even need to apply for an additional business license. But here is a reminder, even if your products are all pure Herbal ingredients, as long as they are not the official batch number of drugs/devices, must not promote any therapeutic effects. I have previously contacted a Taobao shop selling herbal antibacterial creams. Because the details page said "can treat eczema in infants and young children", someone complained to the Municipal Supervision Bureau and was directly fined more than 20,000 yuan. The gain outweighs the loss.

If you are really not sure what business scope your product corresponds to, print out the outer packaging and registration certificates of all the preparations you want to sell, and go directly to the market supervision window of the government service center. The staff will give you the accurate information directly, which is much more reliable than searching for outdated information on the Internet.