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

At present, there are no unified general access requirements for the domestic operation of medical herbal therapy preparations. The core rule is to first match the regulatory classification of the product to obtain the corresponding qualifications, and then go to the market supervision department to add items to the business scope. The access standards for different categories are very different. Don't listen to the upstream supplier and just say "we are medical grade" and just purchase and add items casually. The probability of being pitted is extremely high.

I used to help a herbal therapy studio in Hangzhou get the qualifications. The boss prepared the shoulder and neck soothing essential oil himself. He originally wanted to connect with the surrounding community health service centers. At first, he thought that he could add "sales of medical herbal preparations" to his business scope by just getting an elimination number. As a result, he failed to comply with the drug supervision. After asking, I found out that as long as the product claims to have clear therapeutic effects and directly acts on the disease, it must be certified as a national medicine according to the requirements of traditional Chinese medicine preparations or Chinese patent medicines. If it is a preparation made by a medical institution, it cannot be circulated and sold to the outside world at all, let alone added to the business scope of ordinary commercial entities.

If you are in a category that does not claim to have therapeutic effects and only has auxiliary physical therapy effects, the threshold will be much lower. For example, the medical cold compress patch with added ingredients of mugwort and ginger is a Class I medical device. It only needs to be registered as a Class I medical device and add "Sales of Class I medical devices" to the business scope. As long as there is a compliant storage space and the product purchase ledger can be kept, there are basically no additional thresholds. If it is a Class II medical device such as an herbal hot compress that claims to relieve joint pain and dysmenorrhea, it must be registered as a Class II medical device and have certified quality management personnel. The storage must also meet temperature and humidity requirements and cannot be piled up casually in private houses.

There are quite a lot of controversies in this industry now. Many practitioners who make folk herbal prescriptions feel that supervision is too strict. Many formulas that do have clinical effects cannot obtain drug approval and can only be produced under custom or cosmetic trademarks. In order to sell goods, they can only secretly use "medical" and "therapeutic" sidelines, which has caused more problems of false propaganda; but supervision The caliber at the end of the pipe has always been clear. As long as a product claims to be "medical" or "treatment", it must obtain a license at the corresponding level. Last year, there was a health center in Guangzhou. Its business scope was only general health care services. It sold herbal ointments that claimed to be able to cure eczema. After being reported, it was fined more than 200,000 yuan. It was a real case of exceeding the scope of operations and adding false propaganda.

Even if you have all the qualifications, not everything can be sold. The herbal raw materials used in the preparations you sell must meet the standards of the Chinese Pharmacopoeia, and the pesticide residues, heavy metals, and microbial content must meet the standards. Previously, there was a company in Shandong that made Class II medical devices. A random inspection of a batch of herbal foot soaking bags that came in found that the aflatoxin in safflower exceeded the standard. Not only the products were confiscated, but also the medical device sales qualifications in the business scope were revoked. The gain outweighs the loss.

If you are new to the industry, you don’t need to deal with the high-threshold categories with drug approvals at the beginning. You can start with herbal physiotherapy products in the first and second categories of medical devices. Before applying for qualifications, take the sample registration certificate to the local drug regulatory and municipal supervision departments to make sure that your site and personnel meet the requirements before adding business scope. Don’t be too troublesome, and save yourself from having to pay fines later.