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

Judging from the current practical standards of domestic supervision, the core of the business scope of medical herbal therapy preparations is bound to your pre-approved qualifications. Common business entities can generally cover herbal bacteriostatic preparations with formal approvals, medical herbal physiotherapy preparations with mechanical brands, and herbal preparations with approved Chinese patent names. The business scope of the production side strictly corresponds to the specific categories on the drug/medical device/disinfection product registration approval you have obtained, and production and sales cannot exceed the scope of the approval. If you have obtained the qualification to produce or operate traditional Chinese medicine pieces, then approved herbal fumigation packs and external herbal piece packs for physical therapy are also within the legal scope of business. However, they must strictly follow the regulatory requirements for traditional Chinese medicine pieces and cannot promote their efficacy indiscriminately.

Many friends who have just entered the industry of physical therapy centers and herbal health stores are most likely to fall into this trap. I met the owner of an open neck and shoulder care center in Jianggan District, Hangzhou two years ago. At that time, the license was only approved for the business qualification of Class II medical devices. He privately I found a small workshop to process a batch of ancestral herbal ointment that claimed to be able to cure arthritis. I didn't get any approval documents. It was reported less than two months after it was put on the shelves. The city supervisor directly fined me more than 30,000 yuan for being out of scope and selling unqualified pharmaceutical products. The store also had to make corrections for half a month.

There has been discussion in the industry as to whether herbal conditioning products with the same source of medicine and food can be included in the business scope of medical herbal therapy preparations? Many practitioners feel that since they are used in physiotherapy settings for supporting conditioning, they should be classified into this category, so as not to have to apply for an additional set of food business qualifications. However, the regulatory approach has always been very clear: as long as your product claims to have medical treatment or physiotherapy effects, you must obtain registration approval according to the standards of drugs or medical devices to be considered within the legal business scope. ； If it only claims health-preserving and dietary supplement functions, it can only be classified into the scope of food business and has nothing to do with the scope of medical business.

To put it bluntly, this logic is just like if you open a fruit shop and sell ordinary oranges, it is an ordinary food business. If you dare to say that this is a "medical vitamin C orange" that can prevent and treat colds and supplement medicinal vitamin C, then you must follow the regulatory requirements for pharmaceutical products. Without corresponding qualifications, it is an out-of-scope operation.

If you are planning to apply for a relevant license, do not just fill in a general category such as "medical herbal preparations". It is best to go to the local food and drug supervision and market supervision window in advance and clearly declare the specific products you plan to operate, such as making herbal cold compresses, herbal fumigation packs or herbal antibacterial sprays. Correspondingly, "Second Class Medical Device Operations" and "Retailing of Chinese Patent Medicines" With the addition of specific categories such as "disinfectant products sales", even if you are an online e-commerce company selling such products, the requirements are the same. Last year, I met a merchant who ran a douji store. His business scope did not include disinfectant products, but he secretly sold herbal antibacterial athlete's foot spray. After complaints from consumers, not only was the full deposit deducted, but the store was also restricted and closed for a week, which was not worth the gain.