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Thailand: FDA Announcement on Guidelines subject to Technical Documents Transfer and Refer Implementation – October/November 2024

Thailand: FDA Announcement on Guidelines subject to 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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PHILIPPINES: PFDA Released FDA Circular No. 2021-002-C Further Extending the Application Period for CMDN for Class B, C, and D Medical Devices – April/May 2023

PHILIPPINES: PFDA Released FDA Circular No. 2021-002-C Further Extending the Application Period for CMDN for Class B, C, and D Medical Devices – April/May 2023

  • 2023-04-24 09:37:45

On March 31, 2023, PFDA has once again extended the application period for one more year for medical device products that were previously considered non-registrable, which currently fall under AMDD risk class B-D. PFDA cites the risk of disrupting the supply chain that may negatively impact the quality of the healthcare system in the country.

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