https://en.wikipedia.org/wiki/Microneedles

When consumers excitedly bring home microneedle products for use, few of them will ponder a crucial question: Is it a skincare product or a medical device? This classification is not only related to the registration approval of the product, but also directly affects the safety of consumers' use and their rights and interests protection. Unfortunately, the answers to this question are not uniform worldwide, resulting in a complex regulatory maze.

In China, according to the "Regulations on the Supervision and Administration of Medical Devices," any device that "performs puncture on the human skin to introduce drugs or active ingredients into the subcutaneous tissue" should, in principle, be managed as a second or third category medical device. However, home-use microneedle products are in a blurry area during actual supervision. Microneedle rollers with needle lengths less than 0.3mm and without drug delivery functions are sometimes classified as "ordinary cosmetic tools" by some regulatory authorities; while products with needle lengths over 0.3mm or claiming "delivery" or "enhanced penetration" functions are required to register as medical devices. This "one-size-fits-all" standard is highly controversial in actual implementation, resulting in a large number of products on the market neither obtaining a medical device registration certificate nor being registered as cosmetics, remaining in a gray area.

In the United States, the FDA classifies microneedle products into three categories: If the microneedles are only used for skin puncturing without any accompanying drugs, they are managed as "general medical devices" (Class I), with relatively lenient regulations; if the microneedles are used in combination with drugs (such as drug-loaded microneedle patches), they are regarded as "drug-device combination products," and both drug and device approval requirements must be met simultaneously, with an extremely strict process. The situation in Europe is similar. According to the EU MDR regulations, microneedle products with medical purposes must obtain the CE mark, while products with purely cosmetic purposes are subject to cosmetic regulations.

These differences in regulations pose potential risks for consumers. Many household microneedle products on the market are sold under the guise of "beauty devices," but they have not undergone any safety and efficacy verification. Some inferior products have substandard needle materials, which can cause metal allergies or bacterial infections on the skin after use; other products claim to have "nanometer-sized needles," but this is actually an exaggeration and fails to achieve the claimed penetration effect. When making a purchase, consumers should prioritize choosing products that are labeled with "Medical Device Registration Number" or "Cosmetics Registration Number" on the packaging, and try to select well-known brands or manufacturers with clinical research endorsements.

From the perspective of industry development, it is urgent to establish a unified and clear classification standard for household microneedle products. Relevant Chinese authorities are currently drafting the "Guidelines for Classification and Definition of Microneedle Products," and it is expected to be released within the next two years. At that time, the household microneedle products will undergo a comprehensive reshuffle - non-compliant products will be eliminated, and the innovation drive of compliant enterprises will be further unleashed.

For ordinary consumers, before the regulations are fully established, maintaining rational judgment is the best way to protect themselves. Remember this: The person who should reassure you that they can safely insert a needle on your face is not the recommendation of a popular blogger, but the certification of an authoritative institution.