What is the business scope of medical herbal therapy preparations?

For example, if you are selling medical herbal wound dressings and acupoint pressure stimulation patches that have obtained a Class II medical device registration certificate, then your business scope must have the qualification for "Class II medical device sales"； If you are selling herbal oral preparations and traditional Chinese medicine pieces registered in accordance with the national drug approval, you must apply for a drug business license, and add "retail/wholesale of Chinese patent medicines and traditional Chinese medicine pieces" to the business scope.” ； If it's a herbal antibacterial spray with a brand name, just add "disinfectant supplies sales" ； If it is a medical cold compress patch (cosmetic brand name) that focuses on herbal ingredients, then ordinary "cosmetics retail" qualifications are enough.

I encountered a pitfall two years ago when I was helping a friend to obtain qualifications for opening a physical therapy center. At that time, he wanted to sell a lumbar spine patch that promoted "medical herbal therapy." When purchasing the product, the manufacturer said that it would be distributed as daily necessities. When I got it, I found out that it was a Class II device. At that time, I did not go through the registration of Class II device business to save trouble. It was reported by the public just a week after it was put on the shelves. I was fined more than 18,000 and all the goods were deducted. It was a huge loss.

There is indeed a controversial point in the industry now, that is, many products with the banner of "medical herbal therapy preparations" have neither medical device registration nor consumer brand names, and are produced and sold as ordinary daily necessities. Regarding the business scope of such products, there is a big difference between the regulators and practitioners: many practitioners feel that as long as the product does not clearly claim therapeutic effects and is just ordinary herbal care, it will be fine if it is registered as "daily necessities for sale"； However, the mainstream attitude on the regulatory side is that as long as the word "medical" is included in the product name or promotion, it must be subject to the regulatory scope of medical devices or drugs. If there is no registration, it is a non-compliant product, and there is no legal business issue at all.

To be honest, if you plan to add new business permissions for this type of product, don’t just search for vague answers online. The safest way is to print out all the registration/filing certificates for all the products you want to sell, and go directly to the commercial registration window of the market supervision bureau in your jurisdiction. The review standards in different places are really different. Some areas do not allow vague general items such as "sales of medical herbal therapy preparations" in the business scope, and must be filled out separately according to the regulatory category to which the product belongs.； Some regions allow you to add this general entry as long as you can provide qualification certificates for the corresponding products. You will definitely not go wrong if you follow the window's requirements.