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Thailand: Updated Change Notification Guidelines for IVD and Non-IVD: Model Additions/Removals and Amendments to Thai Establishment Information on Labels – March/April 2025

Thailand: Updated Change Notification Guidelines for IVD and Non-IVD: Model Additions/Removals and Amendments to Thai Establishment Information on Labels – March/April 2025

  • 2025-03-25 10:37:19

The Thai FDA updated its change notification guidelines, effective 15 January 2025, focusing on model additions/removals and importer/manufacturer info updates for both IVD and non-IVD devices. The update allows modifications to groupings when adding or removing products within the same application. Additionally, adding models is now classified as a Major Change, requiring an extensive documentation.

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Thailand: Thai FDA - Updated Advertising License Regulations for Medical Devices – February/March 2025

Thailand: Thai FDA - Updated Advertising License Regulations for Medical Devices – February/March 2025

  • 2025-02-20 11:17:07

From January 4, 2025, onwards, Thai FDA has tightened medical device advertising rules to prevent misleading claims. Advertisements must align with approved product information, specify target audiences, and include required disclaimers. Stricter enforcement measures target misleads advertising, especially for dermal fillers. Likewise Consumers shall verify approved products on the Thai FDA's website, updated on a weekly bases.

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Thailand: Thai FDA Introduced Priority Track for Non-Communicable Disease (NCDs) Medical Devices – February/March 2025

Thailand: Thai FDA Introduced Priority Track for Non-Communicable Disease (NCDs) Medical Devices – February/March 2025

  • 2025-02-20 11:06:06

The Thai FDA has launched a priority track for 6 types of medical devices targeting Non-Communicable Diseases (NCDs), enabling faster approval for essential healthcare solutions. This initiative is designed to ensure quicker access to vital healthcare solutions, providing medical device companies with faster market entry for devices targeting public health challenges.

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Thailand: Thai FDA's Updated Guidance for SaMD/AI Medical Device Registration – December/January 2025

Thailand: Thai FDA's Updated Guidance for SaMD/AI Medical Device Registration – December/January 2025

  • 2024-12-16 07:05:36

Thai FDA has updated its guidance on the registration of Software as a Medical Device (SaMD) and Artificial Intelligence (AI) medical devices. Key revisions include new requirements for establishment licensing, compliance with advertising regulations, and enhanced cybersecurity measures. The updated guidance offers stakeholders a clear framework for classification criteria, document preparation, and post-market responsibilities.

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Thailand: FDA ANNOUNCEMENT ON GUIDELINES SUBJECT TO CLASS 2, 3, AND 4 TECHNICAL DOCUMENTS TRANSFER AND REFER IMPLEMENTATION – October/November 2024

Thailand: FDA ANNOUNCEMENT ON GUIDELINES SUBJECT TO CLASS 2, 3, AND 4 TECHNICAL DOCUMENTS TRANSFER AND REFER IMPLEMENTATION – October/November 2024

  • 2024-11-04 08:50:30

Thai FDA introduced new guidelines for handling the registration of medical devices under Notified (Class 2 & 3) and Licensed (Class 4) Medical Device. Thai FDA permitted referencing of previously approved dossiers when applying for brand name changes ("Refer") and for the transfer of medical device licenses between medical device establishment ("Transfer"). This move aimed to streamline the regulatory process, reduce redundant dossier reviews, and simplify licensing in Thailand's medical device sector.

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Thailand: Thai FDA Implements Urgent Registration for Mpox Test Kits Amid Growing Public Health Concerns – September/October 2024

Thailand: Thai FDA Implements Urgent Registration for Mpox Test Kits Amid Growing Public Health Concerns – September/October 2024

  • 2024-10-10 08:23:53

The Thai Food and Drug Administration (FDA) has initiated a registration process for Mpox diagnostic test kits in response to rising concerns over the spread of the viral infection. This move aims to enhance early detection and management of Mpox cases, ensuring public health safety. The Thai FDA has streamlined the registration process for manufacturers and importers, focusing on quality and accuracy of the diagnostic kits. This initiative is a key step in Thailand's efforts to curb the spread of the virus and strengthen its response to emerging health threats.

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Thailand: Thai FDA Announcement: Exemption of Prescribed Information, Documents, and Evidence for Licensed and Notified Medical Devices, 2024 - August/September 2024

Thailand: Thai FDA Announcement: Exemption of Prescribed Information, Documents, and Evidence for Licensed and Notified Medical Devices, 2024 - August/September 2024

  • 2024-09-17 02:22:43

The Thai FDA has announced significant regulatory changes to accelerate the approval process for medical device manufacturing and importation. Effective June 6, 2024, these changes aim to reduce redundancy in documentation without compromising product safety or quality. This streamlined approach is expected to foster innovation, attract foreign investment, and enhance Thailand's position as a regional healthcare hub.

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THAILAND: Thailand Revolutionizes Dental Care with Stricter Regulations for Safety and Quality: A Breakdown of Key Updates – July/Aug 2024

THAILAND: Thailand Revolutionizes Dental Care with Stricter Regulations for Safety and Quality: A Breakdown of Key Updates – July/Aug 2024

  • 2024-07-30 02:55:19

Thailand's Ministry of Public Health is enforcing stricter rules for dental devices. Specific dental products like implants and orthodontic instruments can only be sold to certified dentists and approved healthcare providers. Distributors must have selling approval certificates for transparent distribution. These changes aim to enhance patient safety and raise dental care standards, requiring quick adaptation from stakeholders.

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THAILAND: GUIDELINE FOR EVALUATING DOCUMENTS FOR CLASS 2,3,4 MEDICAL DEVICES THROUGH CONCISE EVALUATION AND RELIANCE PROGRAM - APRIL/MAY 2024

THAILAND: GUIDELINE FOR EVALUATING DOCUMENTS FOR CLASS 2,3,4 MEDICAL DEVICES THROUGH CONCISE EVALUATION AND RELIANCE PROGRAM - APRIL/MAY 2024

  • 2024-05-07 08:47:38

Thai FDA has replaced its previous criteria for evaluating medical devices via expedited routes with new guidelines published in 2024. The aim is to streamline the evaluation process for Licensed and Notified medical devices (Class 2,3,4) while ensuring quality, efficiency, and safety. The announcement outlines criteria, documents required, and regulatory procedures for the Concise Evaluation and Reliance Program routes under expedited route review.

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