{"id":28092,"date":"2025-12-18T11:52:33","date_gmt":"2025-12-18T04:52:33","guid":{"rendered":"https:\/\/www.mtec.or.th\/en\/?p=28092"},"modified":"2026-03-05T14:26:43","modified_gmt":"2026-03-05T07:26:43","slug":"itap-non-ivd","status":"publish","type":"post","link":"https:\/\/www.mtec.or.th\/en\/itap-non-ivd\/","title":{"rendered":"ITAP and MTEC NSTDA, with the Federation of Thai Industries, Held a Workshop on Medical Device Laws and Registration to Boost Thai Entrepreneurs’ Capacity for International Standards"},"content":{"rendered":"\t\t
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December 16, 2025, Mandarin Hotel Bangkok<\/strong> \u2014 The Ministry of Higher Education, Science, Research and Innovation (MHESI), through the Technology and Innovation Development Support Program (ITAP) and the National Metal and Materials Technology Center (MTEC), Office of National Science and Technology Development (NSTDA), together with the Federation of Thai Industries, organized a training workshop titled \u201cIn-Depth Legal and Registration Processes for Thai Medical Devices, with CSDT Guidelines for Non-IVD Medical Devices\u201d to strengthen entrepreneurs\u2019, researchers\u2019, and stakeholders\u2019 understanding of medical devices regulations and registration.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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The workshop commenced with welcoming remarks by Mr. Wiwat Hemmondharop, Vice Chairman of the Federation of Thai Industries, followed by a lecture on \u201cThe MED Drive Platform: A Driving Mechanism for Thai Medical Devices,\u201d by Dr. Pasu Sirisalee, Senior Researcher at the National Metal and Materials Technology Center (MTEC). Delivered via the NSTDA MED Drive Platform, the session highlighted its role in supporting research, development, testing, standardization, certification, and commercialization of medical devices. The initiative’s aim is to strengthen Thailand\u2019s competitiveness and safeguard long-term public health.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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The event featured expert insights from the Thai Food and Drug Administration (FDA) experts, including Pharm. Ms. Sithara Phuengphinit, Pharm. Ms. Nattaporn Thanyakaset, and Pharm. Mr. Cholasit Jitchaicham \u2014 who addressed key topics including: (1) the risk classification of Non-IVD medical devices, criteria for classification, and the FDA regulatory framework; and (2) registration procedures by risk levels, covering product listing, notifications, and licensing processes under the CSDT format. They also highlighted product testing standards, with emphasis on Verification & Validation Reports and Clinical Evaluation Reports (CER).<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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In the afternoon, MTEC researchers presented case studies on preparing registration dossiers for Class 1 and Class 4 non-IVD medical devices, giving participants practical insights to apply directly. The program also featured company-based consultations led by MTEC experts, offering tailored advice to entrepreneurs. This initiative supports Thai medical device businesses in achieving regulatory compliance, meeting international standards, and enhancing competitiveness at the national and international levels.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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December 16, 2025, Mandarin Hotel Bangkok \u2014 The Ministry of Higher Education, Science, Research and … Read more<\/a><\/p>\n","protected":false},"author":5,"featured_media":28091,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[217,379],"tags":[],"class_list":["post-28092","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-event","category-uncategorized-en","generate-columns","tablet-grid-50","mobile-grid-100","grid-parent","grid-33"],"yoast_head":"\nITAP and MTEC NSTDA, with the Federation of Thai Industries, Held a Workshop on Medical Device Laws and Registration to Boost Thai Entrepreneurs' Capacity for International Standards - MTEC<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.mtec.or.th\/en\/itap-non-ivd\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ITAP and MTEC NSTDA, with the Federation of Thai Industries, Held a Workshop on Medical Device Laws and Registration to Boost Thai Entrepreneurs' Capacity for International Standards - MTEC\" \/>\n<meta property=\"og:description\" content=\"December 16, 2025, Mandarin Hotel Bangkok \u2014 The Ministry of Higher Education, Science, Research and ... 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