Business scope of medical herbal therapy preparations

The current business scope of domestically compliant medical herbal therapy preparations core covers the three major categories of "herbal external preparations managed as Class I/II medical devices, herbal preparations managed in-hospital in medical institutions as traditional Chinese medicine, and herbal care preparations registered as disinfection products/special cosmetics." Cross-category operations must obtain corresponding regulatory qualifications in advance, and claims of medical efficacy beyond the scope are strictly prohibited.

Many people who are new to the health industry tend to confuse this area with the business scope of ordinary Chinese medicine pieces and Shihao health products. When I helped Lao Chen, who opened a traditional Chinese medicine clinic in the west of the city, to run for qualifications two years ago, he had definitely stepped through this big pit.

At that time, Lao Chen's store had just opened, and the business scope only listed two categories: Class I medical device operation and traditional Chinese medicine diagnosis and treatment. He usually sold mugwort hot compress patches and herbal cold compress gel that were registered and were in compliance with regulations. However, he heard from a friend that he had a self-prepared herbal moisturizer. The rash ointment was selling well, and a batch was put on the shelves without registration, and it was labeled "medical grade". Within half a month, it was reported, and not only was it fined 20,000 yuan, but it was also publicized for three months. During that time, the number of customers in the restaurant dropped by half.

Anyone who has stepped on the pit knows that the boundary here seems blurry, but in fact, stepping on the line will result in a penalty.

The specific business requirements for each category are actually directly linked to the business form you do. If you open an ordinary physical therapy center or pharmacy and sell herbal patches with medical device registration numbers, medical herbal hand creams, cold compress gels, etc., you only need to apply for the corresponding category of medical device business registration/license, and don't make any false claims that it can cure skin diseases and joint diseases. If you are operating a medical institution, and the herbal preparations you develop yourself, such as compound comfrey oil and herbal cough patches, can only be opened in your own institution if they are registered as in-hospital preparations. If you want to sell them in external pharmacies or e-commerce platforms, you must go through the approval process in accordance with the requirements of the National Drug Approval. Otherwise, even if the ingredients are all herbal, it is considered an out-of-scope operation.

Oh, yes, there are also many online e-commerce merchants selling herbal antibacterial hand sanitizers and herbal acne creams, which are registered under the elimination brand name or makeup brand name. If you want to add it to the business scope of medical herbal therapy preparations, you must ensure that no medical terms such as "treatment" and "cure rate" are mentioned on the product page or packaging. Otherwise, even if this category is included in your business scope, it will be considered a violation.

There is actually quite a fierce debate in the industry over the boundaries of this area. There is a school of merchants who make herbal care products for civilian use. They think the standards can be relaxed. As long as the ingredients are pure herbs, do not add banned ingredients, and do not actively promote medical benefits, they can be included in this business scope. There is no need to be so stuck, otherwise many old herbal formulas that have been circulated for decades will not be able to be promoted to ordinary consumers. There is also a group of people from public medical institutions and compliant pharmaceutical companies who feel that the boundaries must be strictly defined according to the scope of regulatory filings. Otherwise, there will definitely be a bunch of speculators taking advantage of the loopholes and touting the Xiaozihao herbal cream containing hormones and antibiotics as a "medical miracle drug" to deceive consumers. Isn't this how a batch of Xiaozihao eczema creams for babies containing hormones were exposed in the past two years?

I have been working as a medical qualification agent for almost 6 years, and to be honest, both sides of the argument make sense. If you are just starting a small business and opening a community physical therapy center, fill in the business scope honestly according to the registration scope, and don’t be greedy for too much and ask for everything. ； If you want to make your own brand of herbal products, it is best to go to the local municipal supervision bureau and health department to ask clearly. The implementation standards are actually different in each place. For example, the standards for medical herbal care products with makeup brands in Jiangsu and Zhejiang are wider than in some northern cities.

Anyway, let me give you a final reminder. No matter how you fill out your business scope, you should never touch the core red line: as long as you dare to say that your product can cure a certain type of disease, you must obtain the corresponding medical device or drug registration. Otherwise, no matter how complete the business scope is on your business license, you will be fined if it is found out. Don’t take any chances.