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

Currently, the core requirements for operating medical herbal therapy preparations in China are "qualifications to match product attributes + business scope registration compliance + corresponding pre- and post-licenses". Anything less than this will easily lead to regulatory red lines.

When I helped the owner of a community physical therapy center in Hangzhou to obtain qualifications, he originally wanted to sell mugwort hot compress packs manufactured by his own factory. At first, he thought that he could sell them as long as the business license had "health care services" on it. However, after asking the Municipal Supervision Bureau, he found out that his product The product packaging has a claim of "medical use, relieving rheumatoid joint pain" and belongs to the category of Class II medical devices. Just having a health care business scope is not enough. You must first complete the Class II medical device business registration and add "Class II medical device sales" to the business scope.

The most confusing thing for many people when they first come into contact with this field is that medical herbal preparations with different attributes correspond to completely different business scope requirements. There is no one set of qualifications that can rule the world. If you are selling approved herbal medicines, such as various herbal ointments and Chinese patent medicine oral liquids, then the business scope must clearly add "drug retail/wholesale", and you must obtain a "Drug Business License" in advance. The personnel and storage space must meet the inspection standards of the Food and Drug Administration; if it is medical herbal dressings and antipyretic patches that are registered as Class I medical devices, you do not need to obtain an additional license, but the business scope must include "Sales of Class I Medical Devices".

There are still two controversial issues in the industry, and the implementation standards in different places vary quite a bit. One is homemade herbal preparations made by medical institutions. Many practitioners think that as long as they have a "Medical Institution Preparation License", they can sell them externally. In fact, the current regulatory requirements are clear that such self-made preparations can only be used by patients within the institution. If they want to put them on the market for external sales, You have to go through the normal drug/medical device registration process, and the business scope must be supplemented accordingly, otherwise it will be considered a violation; there is also a product with the same origin of medicine and food under the banner of "medical herbal conditioning". One school of thought believes that as long as there is no clear claim for disease treatment or diagnosis, it can be eaten as ordinary prepackaged food. For food business, just add "food sales (only selling pre-packaged food)" to the business scope. The other group believes that as long as it carries a "medical" related label, it belongs to the category of food for special medical purposes and must obtain a corresponding special food business license. I have encountered merchants in Suzhou selling grass that claim to be "medical grass" The prepackaged food "Ben Yangwei Drink" was required to be rectified because it only had ordinary food business qualifications. I have also encountered merchants in Chengdu making similar products. As long as they do not make any therapeutic claims, they can operate normally. To be on the safe side, it is better to ask the local municipal supervision bureau and health department in advance to avoid stepping into the ambiguity.

By the way, if you are importing and exporting medical herbal preparations, don’t forget to add “import and export of goods” and “technical import and export” to your business scope. Those involved in the import and export of drugs and medical devices must also obtain corresponding customs clearance filings. Last year, a friend who was a cross-border e-commerce business in Guangzhou secretly sold imported herbal cough syrup without following the formal registration process. He was fined hundreds of thousands for selling counterfeit drugs, and the store was closed for half a year. Don’t take any chances.

In fact, if you search for more qualifications, you will find that the requirements in this area are essentially "what effect the product you sell claims to have, it must correspond to the business scope and qualifications of the category." Don't think about blurring product attributes with "herbal" and "natural". Nowadays, the supervision of live broadcast e-commerce and offline stores is becoming more and more strict, and it is better to complete the qualifications in advance than anything else.