Business scope of medical herbal therapy preparations

Herbal dressings, physiotherapy patches and other products that have obtained Class I/II medical device registration certificates must be included in the scope of medical device business； Herbal antibacterial and bacteriostatic preparations that have been registered as Xiaozi must be included in the business scope of disinfection products. ； Herbal medicines that have obtained the national drug approval batch number must be included in the scope of pharmaceutical business. Any behavior that exceeds the scope of business without obtaining the corresponding qualifications will be subject to a fine of up to 30 times the value of the goods.

A while ago, he helped Brother Zhang, who runs a community physical therapy center near his home, handle punishment matters. He fell into a trap in this area. At that time, he bought a batch of mugwort hot compress patches from the wholesale market that were claimed to relieve shoulder and neck pain, thinking that he could sell them with the business license of a health care center. However, during an unannounced inspection by the city supervisor, it was discovered that the patch was a Class II medical device with a batch number. His license did not include a medical device business registration at all. In the end, he was fined 8,000 yuan and the remaining more than 200 boxes of patches were confiscated. He was still talking to me at the time, saying, "Aren't they all made of grass? Why do you still ask for so much?"

In fact, determining whether your business scope is sufficient is like finding an "ID card corresponding seat" for your product. Which type of business scope your product's registered batch number is, you have to sit within that type of business scope. If you sit in the wrong seat, you will be asked to leave. Many bosses who are new to this category are easily confused. Even some products with blurred boundaries in the industry still have different judgment logics. For example, if you claim that essential oils extracted from herbs can relieve muscle strain and assist in the treatment of joint pain, it will fall into the category of Class II medical devices and you must obtain corresponding business qualifications. ； If it is only said to moisturize the skin and relax the mood, then it falls into the category of ordinary cosmetics, as long as there is a cosmetics business registration. ； If you say it can kill fungi and treat athlete's foot, then it is a disinfectant product of a certain brand and requires business approval for disinfection products. Oh, by the way, there are still a few provinces that will classify some herbal preparations used as auxiliary physical therapy into the category of locally approved health products. This depends on the local regulatory rules and cannot be generalized.

Another frequent pitfall is whether the herbal preparations made by hospitals or traditional Chinese medicine clinics can be sold. I once met the owner of a chain drugstore who had a good relationship with the director of the local traditional Chinese medicine hospital. He took a batch of homemade cough herbal ointment and sold it in the store. Within half a month of selling, he was reported. Not only was he fined 30,000 yuan, but all the stock was confiscated. To put it bluntly, the approval documents for in-hospital preparations are only for internal use within the medical institution. If they are to be circulated outside, they must go through additional marketing approval from the Food and Drug Administration. Only after obtaining the formal batch number can they be placed within the business scope according to the corresponding category. Otherwise, even if it is made by a regular hospital, it will be considered a violation.

There are actually two completely different voices in the industry regarding the delineation of this business scope. One group is practitioners who inherit traditional Chinese medicine. They feel that the current classification is too rigid. Many folk herbal prescriptions that have been circulated for decades are obviously very effective, but they cannot be sold in compliance with the regulations without formal medical device or drug approval documents. This is equivalent to cutting off the circulation channels of folk prescriptions and is not conducive to the promotion of herbal therapy. The other group is the regulatory and consumer rights protection practitioners. They feel that the scope must be strictly controlled, otherwise too many Sanwu products will be deceived under the banner of "medical herbs". In the past two years, herbal capsules claimed to be able to cure diabetes were discovered. Large doses of hypoglycemic Western medicine were secretly added to them, which almost killed people. If the scope of business is liberalized, the unlucky ones will be ordinary consumers, especially the elderly with weak discernment ability. Both of these statements are reasonable. Now local supervision is slowly adjusting. Some provinces are already piloting a green channel for the registration of private herbal prescriptions. The scope of business will definitely change in the future.

If you do online channels, the requirements are even stricter. Last month, I helped a customer who ran a Douyin store to replenish his qualifications. He had previously sold mugwort lumbar patches and had not registered for online sales of Class II medical devices. The store was blocked for seven days, just in time for 618, and he lost more than 100,000 in sales. Now, whether it is Douyin, Pinduoduo or Tmall, as long as the product you sell carries claims such as "medical", "treatment" or "auxiliary physical therapy", your business scope qualification will be directly blocked. If it cannot be uploaded, you will be removed from the shelves without even a chance to appeal.

If you are really unsure about which category your product should be classified into or whether your business scope should be expanded, don’t blindly search for half-true and half-false information on the Internet. Go directly to the local drug regulatory window and ask. Spending 10 minutes is better than getting a fine later. After all, the supervision of medical products will only become more and more stringent, and the cost of stepping into a trap is enough for you to apply for qualifications ten times.