"They're all applied to or injected into the face—so why are some called cosmetics, some called medical devices, and some don't even have a legitimate status?" The controversy sparked by South Korea's Re2O (nicknamed "corpse skin needle" by netizens) has made many people realize for the first time: Behind different names are completely different legal identities and regulatory thresholds.
This article does not discuss the commercial success or failure of this product. Based only on China's currently publicly available regulations, it clarifies several easily confused regulatory boundaries. For consumers, this is a guide to avoiding pitfalls; for cosmetics brands and OEM manufacturers, this is the compliance bottom line.
1. First Layer: Ordinary Cosmetics—"Filing System"
According to the Regulations on the Supervision and Administration of Cosmetics, cosmetics refer to daily chemical industrial products applied to the surface of the human body, such as skin, hair, nails, and lips, by smearing, spraying, or other similar methods, for the purpose of cleansing, protecting, beautifying, or modifying.
There are two key phrases here: applied to the surface of the human body and non-medical purposes. Everyday moisturizing creams, hydrating masks, cleansers, and ordinary serums all belong to this category.
- Regulatory method: Ordinary cosmetics are subject to filing management. Domestic ordinary cosmetics must be filed with the drug regulatory authority before marketing and obtain a filing number, commonly in the format "province abbreviation + G makeup network filing + year + number," for example, "Guangdong G makeup network filing...";
- What can be claimed: Within the definition of cosmetics and the scope of efficacy evaluation, claims such as moisturizing, repairing, oil control, and anti-wrinkle (skincare efficacy in the cosmetics context) can be made, but there must be sufficient evidence, and efficacy claim evaluation and filing must be completed;
- What cannot be done: Cannot claim medical effects, cannot use injection, implantation, or other methods, and cannot add prohibited substances.
Special reminder: "Anti-wrinkle" can be a compliant skincare efficacy claim in cosmetics, but terms such as "wrinkle-removal injection," "filling," or "comparable to injection" that align cosmetics with medical procedures are clearly violations and are also high-frequency targets for false advertising complaints and professional anti-counterfeiting claims.
2. Second Layer: Special Cosmetics—"Registration System," Higher Threshold
The Regulations on the Supervision and Administration of Cosmetics classify hair dyeing, perming, freckle removal and whitening, sunscreen, anti-hair loss, and cosmetics claiming new efficacy as special cosmetics, subject to registration management.
- Regulatory method: Must be registered with the drug regulatory authority under the State Council before production or import, and obtain a "National Cosmetics Special Approval Number" (for imports, "National Cosmetics Special Import Approval Number");
- Threshold difference: Compared with ordinary filing, special cosmetics registration requires more complete safety and efficacy data, a longer cycle, and higher requirements;
- Common misconception: An ordinarily filed mask or serum cannot casually claim "whitening and spot removal" or "freckle removal"; as long as the whitening concept is used, a special approval certificate must be obtained first. This is also why compliant OEM manufacturers, when taking on whitening orders, separately confirm whether the client is using a certified finished product or going through special certification customization.
3. Third Layer: Medical Devices—Three Classes by Risk, the Higher the Risk, the Stricter the Control
When a product goes beyond "surface application," claims medical use, contacts wounds, or acts on the human body by injection or implantation, it enters the regulatory scope of medical devices or even drugs.
China's medical devices are divided into three classes according to risk level:
- Class I: Low risk, subject to filing management, such as some conventional medical consumables;
- Class II: Moderate risk, subject to registration approval by provincial drug regulatory authorities, commonly "X Medical Device Registration Certificate";
- Class III: Higher risk, such as implantable and life-sustaining devices, subject to registration approval by national drug regulatory authorities, commonly "National Medical Device Registration Certificate," with the strictest requirements, usually requiring clinical trial support.
Injectable sodium hyaluronate fillers (commonly known as compliant hyaluronic acid injections), collagen fillers, etc., are generally regulated in China as Class III medical devices, must obtain a "National Medical Device Registration Certificate," and be used in compliant medical institutions. If a product only has a cosmetics filing number but is injected as a needle or claims filling and shaping, it is a thoroughly illegal product.
It should be noted that there are also products regulated as medical devices on the market, such as "medical dressings" and "cold compress patches." They have clear scope of application (e.g., superficial wound care), cannot be packaged as daily "medical device masks" for long-term use on healthy skin, and certainly cannot imply miraculous beauty effects under the name of medical device registration—this is also a chaos that regulators have focused on in recent years.
4. Fourth Layer: Human Tissue—A Special Restricted Zone of Ethics and Safety
What makes Re2O special is that it does not belong to any of the above conventional categories. According to public reports, its raw material is extracellular matrix (ECM) from deceased donor skin after decellularization; in South Korea, it is classified under the "human tissue" framework, not as a drug or ordinary medical device, and therefore does not need to undergo the strict clinical trials required for drugs or devices.
In China, however, the collection and use of human tissues and organs are subject to strict legal regulation and ethical requirements. According to reports from China Newsweek, Shenzhen News, and other media, domestic authoritative experts have clearly pointed out: Under Chinese law, the buying and selling of human tissue is prohibited; if such products are to enter China, they face fundamental obstacles at the ethical, clinical evidence, and approval levels. As of now, public reports show that the product has not been approved by China's drug regulatory authorities, and the U.S. FDA has also not approved it for medical aesthetics injections.
This means that any institution or channel in China providing this injection is an illegal "gray market" product of unknown origin. Consumers face not only uncertain effects but also risks of sterility assurance, immune reactions, granulomas, and other complications, as well as the difficulty of tracing the source and defending their rights if problems occur.
5. One Table to Understand the Four Identities
| Dimension | Ordinary Cosmetics | Special Cosmetics | Medical Devices (e.g., injectable fillers) | Human Tissue-Derived Products |
|---|---|---|---|---|
| Mode of action | Surface application | Surface application | Injection/implantation, etc. | Injection/implantation, etc. |
| Regulatory method | Filing | Registration | Classified filing/registration (fillers mostly Class III) | Special laws and ethical review for human tissue |
| Approval number | Provincial network filing, etc. | National Cosmetics Special Approval Number | Device filing/registration (National Device Registration Certificate) | Requires special approval; China currently has no such medical aesthetics product approved |
| Typical products | Moisturizing cream, hydrating mask | Whitening, sunscreen products | Compliant hyaluronic acid filler injection | Re2O (overseas, not entered China) |
| Usage scenario | Personal daily care | Personal daily care | Legitimate medical institutions | Mainly serious medical use, ethically restricted |
Conclusion: Numbers Speak; Verification Takes Only One Step
No matter how appealing the marketing story is, the most effective way to judge whether a product is reliable is to check the number and verify with official sources: ordinary cosmetics and special cosmetics can be checked through the National Medical Products Administration's "Cosmetics Supervision" App for filing/registration information, and medical devices can be checked for registration certificates. If it cannot be found or does not match, stay vigilant no matter how cheap or popular it is.
For cosmetics practitioners, this boundary is also a lifeline: Do cosmetics matters honestly within the cosmetics regulatory framework; never overstep claims for content belonging to medical devices or medical procedures. Compliance may seem slow, but it is the only path that allows brands and factories to go far.
(The regulatory content in this article is compiled based on publicly available regulations such as the Regulations on the Supervision and Administration of Cosmetics and the Regulations on the Supervision and Administration of Medical Devices. Facts related to Re2O are synthesized from authoritative media reports such as China Newsweek; the specific regulatory identity of products shall be subject to official information from drug regulatory authorities. This article does not constitute legal or medical advice.)
Frequently Asked Questions (FAQ)
Q1: What is the difference between a filing number and a registration certificate number?
Ordinary cosmetics are filed, while special cosmetics and most medical devices are registered; registration review is stricter and has a higher threshold.
Q2: Can a product with a filing number be safely injected?
Absolutely not. Cosmetics are only for surface application of the human body. Any injection should correspond to a compliant medical device and be used in a medical institution.
Q3: Is a "medical device mask" more advanced?
This is a common misconception. Medical dressings have specific scope of application and are not equivalent to daily masks. For daily care of healthy skin, ordinary or special cosmetics should be chosen.
Q4: Why do whitening products need separate registration?
Whitening is a special cosmetics efficacy and must obtain a "National Cosmetics Special Approval Number" registration certificate. Ordinarily filed products may not claim whitening.
Q5: How can I verify the true identity of a product?
Log on to the official website of the National Medical Products Administration or use the "Cosmetics Supervision" App, enter the product name or number to query. Information on cosmetics and medical devices can be officially checked.
