What is the business scope of medical herbal therapy preparations?

The core boundary is actually very clear, that is, all businesses that can be included in this business scope must be R&D, production, sales, and clinical guidance services related to herbal preparations that have been approved by the drug regulatory department and obtained medical qualifications for the corresponding categories (Class I/II medical device registration certificates, medical institution preparation registration numbers, national drug approval letters starting with B, etc.). Herbal products that have not obtained corresponding medical qualifications cannot be operated in this category.

Last month, I helped a friend who runs a traditional Chinese medicine physical therapy center in Hangzhou to expand his business scope. At first, he wanted to include his home-made herbal body care bags in this category, but he was directly called back by the staff at the government affairs window. They said it very clearly, what are you doing? Each toiletry package comes with a brand name, so if you want to add it, you have to add a separate category for the sale of disinfectant products. The category of medical herbal therapy preparations only recognizes products with medical qualifications, such as approved acupoint patches and traditional Chinese medicine atomizers used in your store, to be included.

There have been a lot of debates about this boundary in the industry in the past two years, especially regarding the circulation of homemade herbal preparations in hospitals. Many practitioners in grass-roots traditional Chinese medicine centers feel that some herbal ointments prepared by themselves and used for more than ten years have stable effects and no safety issues. However, the formal medical registration process is too time-consuming and cost-intensive. Can the scope be relaxed to allow circulation and sales in a small area? However, the regulatory side insists that it is not yet Once self-made preparations that have been clinically verified in large samples are labeled as "medical", it is easy to face the issue of safety risks and accountability. Both sides are justified, but the actual implementation is still subject to regulatory requirements. Last year, a traditional Chinese medicine clinic in Guangdong had all illegal income confiscated and fined 120,000 yuan for privately selling unregistered homemade herbal "medical analgesic ointment." It was a painful lesson.

If you are a production company, then the content in your business scope must strictly correspond to the categories on your medical device production license or drug production license. For example, if you approve the production of medical mugwort moxibustion sticks, you cannot privately produce unregistered herbal lozenges and put them in this category.； If you are a circulation or service entity, then the products you can sell and use for patients can only be products that upstream manufacturers have obtained corresponding medical qualifications. Don't just rely on "medical use" by blindly deploying them yourself.

In fact, to put it bluntly, it’s not that complicated. Just keep an eye on the qualification approval document in your hand and do whatever is in the approval document. Don’t think about taking advantage of the ambiguity. After all, it involves medical categories and supervision is already strict. You can’t step on the red line just for a small profit, right?