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(Unofficial Translation) - Ministry of Public Health

    https://www.fda.moph.go.th/sites/fda_en/Shared%20Documents/Med%20ACT_2008.pdf
    (10) medical devices which must be sold only to medical centres or medical and public health practitioners, as well as the rules, procedures and conditions for selling medical devices; (11) medical devices of which manufacture, import or sale are …

Thailand: Medical Device Control and Regulation | 40

    https://www.taylorfrancis.com/chapters/edit/10.1201/9781003207696-40/thailand-medical-device-control-regulation-kanokorn-pulsiri-sirinmas-katchamart-sansanee-pinthong-korrapat
    The Ministry of Public Health enacted the Medical Device Act, B.E. 2531 and had been in force since May 23, 1988, requiring the registration of all medical devices, including …

New Medical Device Act in Thailand - Pacific Bridge Medical

    https://www.pacificbridgemedical.com/news-brief/new-medical-device-act-in-thailand/
    The Act defines and prohibits fake, unsafe, and nonstandard medical devices. Such devices include products non-compliant with applicable standards, …

An overview of the medical device regulatory requirements in …

    https://globalregulatorypress.com/issue_articles/an-overview-of-the-medical-device-regulatory-requirements-in-thailand/
    To resolve this issue and establish suitable regulatory controls, the Thai government devised the Medical Device Act, B.E. 2531 (1988) (the old Act), which was …

An overview of the medical device regulations in …

    https://www.linkedin.com/pulse/overview-medical-device-regulations-thailand-

    ASEAN MEDICAL DEVICE DIRECTIVE

      https://www.access2hc.com/asean-medical-device-directive-where-is-it-now/
      Planned changes to Class B MD registration. The EBR-1 and EBR-2 routes will be removed and will be merged into the IBR route if they meet certain criteria. …

    B.E. 2551 (2008) BHUMIBOL ADULYADEJ, REX; His …

      https://asiaactual.com/wp-content/uploads/2020/11/MedicalDeviceAct_BE2551.pdf
      Section 1. This Act is called the “Medical Device Act B.E. 2551 (2008)”. Section 2. This Act shall come into force as from the day following the date of its publication in the …

    THAILAND: ThaiFDA Issues the Amended Medical Device Act …

      https://www.qualtechs.com/en-gb/article/384
      Medical Device Act (Issue 2) B.E. 2562 (2019), enacted by the King Rama 10th, by and with the advice and consent of National Legislative Assembly, is divided into …

    South-East Asia - Qserve® Group

      https://www.qservegroup.com/eu/en/services/regulatory-affairs/global-registration/south-east-asia
      The Medical Device Control Division (MDCD) of the Thai Food and Drug Administration (TFDA) is the division which regulates and monitors Quality, Efficiency and Safety of …

    MAY 2019 SPECIAL REPRINT - Tilleke & Gibbins

      https://www.tilleke.com/wp-content/uploads/2019/09/JMDRMay2019-Reprint-Thailand.pdf
      the Medical Device Act, B.E. 2531 (1988) (the old Act), which was enacted on 23 May 1988 and established the MDCD as the governing authority for medical devices within the …



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