What does the business scope of medical herbal therapy preparations include?

The current business scope of domestically compliant medical herbal therapy preparations focuses on the research and development, production, sales and supporting diagnosis and treatment services of medical herbal related products that have been approved and filed by regulatory authorities. The specific boundaries completely match the type of access qualification you hold. The risk of operating beyond the scope is very high.

Two years ago, when I helped an entrepreneurial team in Hangzhou that made herbal throat sprays to apply for qualifications, they initially wanted to classify this preparation that claimed to be able to relieve the discomfort of pharyngitis into the disinfectant category. They just filled in "disinfectant product sales" in the business scope, but the result was directly refuted by the Municipal Supervision Bureau window. According to the report, this kind of herbal preparations that come into contact with mucous membranes and claim to have medical auxiliary therapeutic effects must be declared as Class II medical devices or approved as proprietary Chinese medicines. The business scope must be in the corresponding category of "Sales of Class II medical devices" or "Retailing of proprietary Chinese medicines" before they can be sold legally.

Of course, there are still many areas in the industry where the boundaries are not completely unified. The most controversial issue is how to count the herbal preparations made by traditional Chinese medicine clinics. For example, many clinics prepare their own bruises for external application and herbal medicine packs for warm moxibustion. They are only used by patients who come to the store for medical treatment and are not sold to the outside world. Some practitioners and local regulators believe that such preparations are supporting consumables for diagnosis and treatment services. As long as the diagnosis and treatment qualifications of the clinic cover items related to traditional Chinese medicine and physical therapy, there is no need to add separate preparations to the business scope. ； However, there are also opinions that as long as they are batch-produced medical herbal preparations, even if they are only circulated in the museum, they must be registered in the hospital. The business scope must be supplemented by categories related to "in-hospital preparation sales" and "processing of traditional Chinese medicine pieces". The regulatory standards in different places are indeed very different. I went to Guangzhou last month to attend a traditional Chinese medicine course During the pharmaceutical industry summit, I also heard from local regulators that they have now opened a simple registration channel for small batches of herbal preparations used by traditional Chinese medicine clinics for their own use. As long as they are not sold to outsiders, there is no need to specifically change the business scope. If you want to sell to other institutions or online platforms, you need to supplement the corresponding qualifications and business scope categories.

In addition to the R&D, production and sales of the product itself, if you also provide R&D services for customized herbal preparations for medical institutions, and provide physical therapy guidance for users to use the preparations, you only need to add basic categories related to health consulting and technology development to your business scope, and you do not need to apply for special qualifications separately. To be honest, if you are new to the industry, please don’t fill in the business scope randomly. There used to be a merchant in Suzhou who made mugwort soothing facial masks. They were qualified as cosmetics brands, so they added “sales of medical herbal therapy preparations” to their business scope. They also advertised that the products could treat sensitive skin. In the end, not only was the business scope forced to change, but they were also fined more than 200,000 yuan. They almost closed the store due to losses. There is really no need to step into such an obvious trap.