{"id":2019,"date":"2025-11-24T12:16:02","date_gmt":"2025-11-24T05:16:02","guid":{"rendered":"https:\/\/mednovum.com.vn\/?post_type=dich_vu&p=2019"},"modified":"2025-11-28T18:05:35","modified_gmt":"2025-11-28T11:05:35","slug":"thai-lan","status":"publish","type":"dich_vu","link":"https:\/\/mednovum.com.vn\/en\/dich-vu\/thai-lan\/","title":{"rendered":"Thailand"},"content":{"rendered":"

THAILAND<\/h2>\n\t
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The Thailand market is becoming a key investment center for the global medical device industry, supported its significant market extent and high reliance on imports. As one of the leading \u201cmedical hubs\u201d in Southeast Asia, Thailand attracts a large number of international patients to perform cosmetic services, orthopedic surgery, assisted reproduction (IVF) and chronic disease treatment, creating a strong driving force for the demand for imported medical device. The remarkable development of the medical tourism field contributes to promoting the growth of this vibrant market, while domestic production capacity has not yet fully met market demand. Catching hold of the great opportunities ahead, MedNovum wishes to support and accompany Owners to access and expand business activities in this potential market.<\/p>\n\n\t\t<\/div>\n\t<\/div>\n<\/div><\/div><\/div><\/div>

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Definition of medical devices<\/h2>\n\t
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Under the Medical Device Act B.E. 2551 (2008), as amended by the Medical Device Act (No. 2) B.E. 2562 (2019), a medical device is defined as follows.<\/p>\n

\"\"Medical Device\u201d means:<\/p>\n

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  1. An instrument, tool, mechanical device or object that is used for insertion into body, fluid for laboratory examination, product, software or any other object specifically intended by the manufacturer or the product owner for one of the following uses with a human or animal body, either solely or as a constituent or accessory of any other object:<\/li>\n<\/ol>\n

    a. diagnosis, prevention, monitoring, treatment, relief or cure of disease;<\/p>\n

    b. diagnosis, monitoring, treatment, relief or cure of injury;<\/p>\n

    c. inspection, replacement, remedy, alteration, support, sustainment or aid pertaining to the anatomy or body process;<\/p>\n

     d. life support or aid;<\/p>\n

    e. contraception or promotion of fertility;<\/p>\n

    f. assistance or compensation for a disability or handicap;<\/p>\n

    g. g.generation of data from the examination of specimen extracted for medical or diagnostic purposes; or<\/p>\n

    h. disinfection or sterilization of medical device.<\/p>\n

    2. An accessory to be used together with the medical device under (1); or;<\/p>\n

    3. Other instrument, tool, mechanical device product or object as prescribed by Notification of the Minister as medical device.<\/p>\n

    The accomplishment of purposes of the articles stated in (1) which occurs within a human or animal body must not be the result of a pharmacological, immunological or metabolic process.<\/p>\n\n\t\t<\/div>\n\t<\/div>\n<\/div><\/div><\/div><\/div>

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    Classification<\/h2><\/div><\/div><\/div>
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    Type<\/strong><\/td>\nRisk level<\/strong><\/td>\n<\/tr>\n
    1<\/td>\nLow risk<\/td>\n<\/tr>\n
    2<\/td>\nLow to moderate risk<\/td>\n<\/tr>\n
    3<\/td>\nModerate to high risk<\/td>\n<\/tr>\n
    4<\/td>\nHigh risk<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n\t\t<\/div>\n\t<\/div>\n<\/div><\/div><\/div><\/div>

    Competent Authorities and Registration Process<\/h2>\n\t
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    The competent authoty that licenses and regulates the circulation of medical devices is the Medical Devices Control Division (MDCD) of the Thai Food and Drug Administration (Thai FDA).<\/p>\n\n\t\t<\/div>\n\t<\/div>\n\n\t

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    Options for registration applicant<\/h2>\n\t
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    Our Services<\/h2>\n