What is the business scope of medical herbal therapy preparations

The core of the current business scope of domestically compliant medical herbal therapy preparations is to strictly focus on the scope of product qualification approval you hold, and must not exceed the boundaries of approved product categories, usage scenarios and sales channels.

In the past two years, I have helped several friends who open traditional Chinese medicine health centers and grassroots clinics go through the qualification declaration process, and I have a clear understanding of the details. To give you the most common example, if your products are medical herbal cold compress gels and herbal stress relief patches that are registered as medical devices, then when you operate At that time, you could only sell products with clearly marked functions such as physical cooling, body surface soothing, and acupoint pressure stimulation. If you secretly sell homemade herbal ointments that you made yourself and claim to cure joint pain, then you are operating outside the scope of your business. If you are found out, your income will be confiscated, and your business license will be revoked.

One thing that is still being debated in the industry is that many veteran doctors who have been working in traditional Chinese medicine clinics for half their lives feel that the external herbal lotions and internal conditioning creams they hand-process according to the ancient recipes passed down for generations have real clinical effects. Why are they not considered medical herbal therapy preparations and cannot be included in the scope of business for sale? However, the attitude of the regulatory authorities has always been very clear. If a product wants to claim to have medical therapeutic effects, whether it is hand-cooked or factory-standardized mass-produced, it must first go through the approval process of the Food and Drug Administration, either to obtain the approval document of the National Drug Approval, or to go through the special registration of traditional Chinese medicine preparations from medical institutions. Without legal qualifications, such preparations can only be used within the institution for patients according to medical advice, and cannot be sold separately at a separate price, let alone be wholesaled and retailed within the scope of business.

Some merchants have obtained qualifications for herbal bacteriostatic preparations under the Xiaosha brand, and their business scope can only be framed in the "sale of disinfection and antibacterial products". Medical-related propaganda such as "treatment" and "radical cure" must not be used. I knew an owner who opened a community physical therapy shop and stepped into this before. What a scam. They were clearly selling Xiaozihao’s herbal foot antibacterial liquid. Instead of putting up a poster at the door claiming that it could cure tinea pedis, people complained to the Municipal Supervision Bureau. Not only did they have to refund consumers’ money, but they were also fined 18,000 yuan. This was because of excessive publicity and the fact that Xiaozihao products were sold for medical purposes, which is illegal.

To put it bluntly, this business scope is similar to the driver's license in your hand. C2 can only drive automatic transmission cars. If you have to drive a manual transmission or a large truck, you will be driving without a license. When you apply for the qualification, you can operate whatever type of herbal preparations you are approved to do. Don't always think about "ancient prescriptions" and "folk secret recipes". If you really step on the regulatory red line, fines are still a trivial matter. You will lose money if you lose your business qualifications.