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

At present, the business scope of domestically compliant medical herbal therapy preparations is mainly tied to the business qualifications you hold. Which categories can be covered depends entirely on the scope of the license you have obtained. There is no unified fixed list.

Let me tell you the most common situation first. If you only have ordinary daily necessities business qualifications and a Class I medical device business registration, then the only medical herbal products that can be sold legally are Class I medical herbal products, such as the commonly used medical herbal cold compress patches, herbal cold compress gel for bruises, and medical wound care dressings with herbal ingredients. These products are only used to assist physical care and do not claim medicinal effects. The entry threshold is not high.

If you obtain a Class II medical device business license, your business scope can be expanded to categories with auxiliary treatment properties, such as medical herbal ointments for soothing care for atopic dermatitis, herbal medical essences for post-art repair care, and medical herbal sprays for relieving symptoms of allergic rhinitis. Such products have passed clinical verification and can be labeled with clear medical auxiliary effects, and control will be much stricter. If you still hold a drug business license, you can also add medical herbal preparations with national drug approval, such as herbal cough syrups with national drug approval, and medicinal-grade herbal external plasters. These are regular drugs, and their sales must comply with the classification management regulations of prescription drugs and over-the-counter drugs.

There is still a lot of disagreement in the industry as to whether herbal antibacterial preparations with a certain brand name are included in this category. Many friends who run health centers and physical therapy shops believe that herbal lotions and antibacterial sprays with a medical claim should also be included. However, the current judgment of the regulatory authorities is that as long as a product with a certain brand name does not have the words "medical preparation" or "drug approval" on it, even if the packaging is marked with "medical" related words, it is considered illegal propaganda and is not considered a formal medical herbal therapy preparation and cannot be included in this business scope. I ran into this trap two years ago when I was helping a friend check the qualifications of a community physical therapy center. He bought a batch of products with a brand name marked "Medical Herbal Antibacterial Hand Sanitizer" and wanted to add them to the business category. However, the city supervisor directly called back and said that the products with a brand name canceled could only be included in the business of disinfectants. If he dared to sell the products with the word "medical" on them, he would be punished for false advertising.

By the way, friends who are new to the industry can easily confuse ordinary herbal health products with medical ones. For example, ordinary mugwort foot soaking bags are daily necessities, but if the package is marked with "medical grade, auxiliary treatment of athlete's foot" and a formal first-class equipment registration number, then it is considered a medical herbal therapy preparation, and it must have corresponding qualifications before it can be sold. Don't be confused and be fined for operating outside the scope.