{"id":3560,"date":"2026-04-29T09:50:00","date_gmt":"2026-04-29T09:50:00","guid":{"rendered":"https:\/\/zpthai.com\/?p=3560"},"modified":"2026-04-29T09:50:02","modified_gmt":"2026-04-29T09:50:02","slug":"interpretation-of-thailands-microneedle-cosmetic-regulations-compliance-differences-at-a-glance","status":"publish","type":"post","link":"https:\/\/zpthai.com\/ja\/interpretation-of-thailands-microneedle-cosmetic-regulations-compliance-differences-at-a-glance\/","title":{"rendered":"\u30bf\u30a4\u306e\u30de\u30a4\u30af\u30ed\u30cb\u30fc\u30c9\u30eb\u5316\u7ca7\u54c1\u898f\u5236\u306e\u89e3\u91c8\uff1a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u9055\u3044\u3092\u4e00\u89a7\u3067"},"content":{"rendered":"<p class=\"wp-block-paragraph\">The Thai Food and Drug Administration (Thai FDA) recently released an official infographic regarding the regulatory requirements for microneedle-based cosmetics. The primary objective is to clarify which types of microneedles are permissible as cosmetics and which are strictly prohibited. Below is a breakdown of the core policy points:<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">I. Regulatory Boundaries for Microneedle Products<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>1. Dissolving Microneedle Patches \u2014 Permitted as Cosmetics<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Definition:<\/strong> Microneedle products where the needles can completely dissolve, used in a patch format.<\/li>\n\n\n\n<li><strong>Regulatory Requirements:<\/strong>\n<ul class=\"wp-block-list\">\n<li>Needle length must be <strong>$\\le$ 100 microns (0.1 mm)<\/strong>, acting only on the surface layer of the skin.<\/li>\n\n\n\n<li>Products must not claim any medical benefits, such as therapeutic treatments, medical aesthetics, or tissue repair.<\/li>\n\n\n\n<li>Registration and marketing follow standard cosmetic procedures.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Legal Basis:<\/strong> Section 35 of the Thailand <em>Cosmetic Act<\/em>.<\/li>\n\n\n\n<li><strong>Summary:<\/strong> If it is dissolving, has needles $\\le$ 100 $\\mu$m, and avoids medical claims, it can be marketed as a cosmetic.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>2. Non-dissolving Microneedles \/ Micro-spicules \u2014 Prohibited as Cosmetics<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Definition:<\/strong> Needles made of insoluble materials such as silicon, glass, mineral crystals, or plant hard spines.<\/li>\n\n\n\n<li><strong>Regulatory Determination:<\/strong>\n<ul class=\"wp-block-list\">\n<li>Regardless of needle length, these cannot be marketed as cosmetics.<\/li>\n\n\n\n<li>They are categorized strictly as <strong>medical devices<\/strong>.<\/li>\n\n\n\n<li>They may not be promoted or sold under the guise of cosmetics.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Summary:<\/strong> Non-dissolving microneedles are completely banned from the cosmetic category.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">II. Essential Compliance Actions for Enterprises<\/h3>\n\n\n\n<ol start=\"1\" class=\"wp-block-list\">\n<li><strong>Product Category Self-Inspection:<\/strong> Verify if the needles are dissolving, confirm the length is $\\le$ 100 $\\mu$m, and ensure no insoluble crystal structures are present.<\/li>\n\n\n\n<li><strong>Marketing Content Review:<\/strong> All medical implications, including terms like &#8220;treatment,&#8221; &#8220;repair,&#8221; &#8220;medical beauty,&#8221; &#8220;scar fading,&#8221; or &#8220;wrinkle removal,&#8221; are prohibited. Violations in advertising will be penalized under the <em>Cosmetic Act<\/em>.<\/li>\n\n\n\n<li><strong>Compliance Timeline:<\/strong> The Thai FDA has established a transition period, with full enforcement expected to begin in <strong>April 2026<\/strong>.<\/li>\n<\/ol>\n\n\n\n<h3 class=\"wp-block-heading\">III. Penalties for Non-compliance (Local Thai Regulations)<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><td><strong>Subject<\/strong><\/td><td><strong>Penalty Measures<\/strong><\/td><\/tr><\/thead><tbody><tr><td><strong>Manufacturer \/ Importer \/ Distributor<\/strong><\/td><td>Up to <strong>2 years imprisonment<\/strong> and\/or a fine of <strong>200,000 Baht<\/strong><\/td><\/tr><tr><td><strong>Retailer<\/strong><\/td><td>Up to <strong>6 months imprisonment<\/strong> and\/or a fine of <strong>50,000 Baht<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\">IV. Simplified Compliance Summary<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><td><strong>Product Type<\/strong><\/td><td><strong>Compliance Status<\/strong><\/td><td><strong>Core Requirements<\/strong><\/td><td><strong>Consequences of Violation<\/strong><\/td><\/tr><\/thead><tbody><tr><td><strong>Dissolving Microneedle Patch<\/strong><\/td><td>\u2705 Permitted<\/td><td>Needle length $\\le$ 100 $\\mu$m; no medical claims; registered as a general cosmetic.<\/td><td>Illegal claims are penalized under the <em>Cosmetic Act<\/em>.<\/td><\/tr><tr><td><strong>Non-dissolving Micro-spicule \/ Microneedle<\/strong><\/td><td>\u274c Prohibited<\/td><td>Cannot be marketed as a cosmetic; must be registered as a medical device.<\/td><td>Penalized as an illegal cosmetic; up to 2 years imprisonment + 200,000 Baht fine.<\/td><\/tr><\/tbody><\/table><\/figure>","protected":false},"excerpt":{"rendered":"<p>The Thai Food and Drug Administration (Thai FDA) recently released an official infographic regarding the regulatory requirements for microneedle-based cosmetics. The primary objective is to clarify which types of microneedles are permissible as cosmetics and which are strictly prohibited. Below is a breakdown of the core policy points: I. Regulatory Boundaries for Microneedle Products 1. [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":3561,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_uag_custom_page_level_css":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"spectra_gs_classes":"[\"\"]","footnotes":""},"categories":[44],"tags":[],"class_list":["post-3560","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-thailand-cosmetic-news"],"aioseo_notices":[],"aioseo_head":"\n\t\t<!-- All in One SEO 5.0.3 - aioseo.com -->\n\t<meta name=\"description\" content=\"The Thai Food and Drug Administration (Thai FDA) recently released an official infographic regarding the regulatory requirements for microneedle-based cosmetics. 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