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

The core premise of operating medical herbal therapy preparations is to first clarify the regulatory classification of the product. The qualification requirements and compliance standards of different classifications are very different. This is the bottom line that all practitioners must first understand. There are no universal unified requirements. It all depends on which regulatory opening the product in your hand belongs to.

The first pitfall that many people who are new to the industry often fall into is that they regard "medical herbs" as a unified category. In fact, from a regulatory perspective, there is no such separate classification at all. They are either classified into traditional Chinese medicine preparations managed according to the national drug approval number, or medical consumables managed according to the medical brand name, or ordinary herbal products under the consumer brand name and makeup brand name. Only the first two categories can legally be labeled as "medical".

If you are operating medical herbal preparations that are approved by the state, such as approved medicinal herbal ointments and hospital-customized herbal treatment preparations, then the business scope must have a "drug retail" or "drug wholesale" category. Apply for a "drug business license" in advance. The store must have a licensed pharmacist on duty, and the warehouse must comply with GSP's temperature, humidity, and zoning storage requirements. There must be no sloppiness. Two years ago, I came into contact with an owner of a community physical therapy center. He used a relationship to purchase a batch of herbal topical medicines that claimed to be able to treat bone and joint pain. He thought they were ordinary physical therapy products and put them out for sale. However, it turned out that these medicines were managed as Class II Chinese medicines. He had no drug business qualifications. In the end, he not only confiscated all the inventory, but also fined him 120,000 yuan. The store was closed for almost three months for rectification.

If they are medical herbal products with mechanical brands, such as the common medical herbal cold compresses, first-class moxibustion sticks, and herbal disinfectant preparations for wound care, the requirements will be looser. Just add "sales of first-class medical devices" and "sales of second-class medical devices" in the business scope. For second-class products, you only need to make a business record and do not need a license. However, you must verify the manufacturer's device number when purchasing, and do not touch OEM goods of unknown origin. I have a friend who is an e-commerce business who sold herbal hemorrhoid ointment under the brand name "Mechanical" a few years ago. At first, he thought it was troublesome and did not add Class II medical devices to his business scope. After complaints from peers, all related products in the store were removed from the shelves. It took him half a year to make up for the registration and go through the review process. He missed the peak sales season that year and lost hundreds of thousands.

It should be mentioned in particular that many merchants are now playing the wrong game and promoting herbal products with ordinary cosmetic or consumer brands as "medical". This is an absolute red line. Even if your business scope includes the sale of cosmetics and disinfection products, as long as the product does not have a medical approval or medical brand, mentioning words such as "medical", "treatment" and "diagnosis and treatment" is considered false advertising, and if you are complained, you will be fined or even shut down.

There is actually a lot of controversy over the definition of this area in the industry. Some areas believe that herbal preparations are considered medical as long as they are used in regular medical institutions and are used for auxiliary treatment. Traditional Chinese medicine clinics can prepare and use them by themselves after filing. In some areas, it is very strict. All herbal preparations claiming to have therapeutic effects must be approved according to the requirements of drugs or Class II devices. There is no middle ground. If you are just planning to enter the industry, don’t just read the general requirements online. It is best to go to the local market supervision bureau and health commission to ask clearly about the local regulatory standards, and then go through the corresponding business scope expansion, which can save a lot of trouble later.

If you not only sell preparations but also provide supporting medical herbal physiotherapy services, then you need to add an additional business scope related to "medical services" and obtain a "Medical Institution Practice License". If you only provide general health care herbal care, it is enough to add "health care services (non-medical)" to your business scope. Don't promote the treatment effects indiscriminately.