{"id":2021,"date":"2025-11-24T12:17:56","date_gmt":"2025-11-24T05:17:56","guid":{"rendered":"https:\/\/mednovum.com.vn\/?post_type=dich_vu&p=2021"},"modified":"2025-11-27T17:53:38","modified_gmt":"2025-11-27T10:53:38","slug":"dai-loan","status":"publish","type":"dich_vu","link":"http:\/\/mednovum.com.vn\/en\/dich-vu\/dai-loan\/","title":{"rendered":"Taiwan"},"content":{"rendered":"

TAIWAN<\/h2>\n\t
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Entering the Taiwan market offers a promising gateway for medical device manufacturers, particularly those with advanced and innovative products. However, successfully navigating its distinct regulatory framework demands strategic planning.<\/span><\/p>\n

The Taiwan Food and Drug Administration (TFDA), under the Ministry of Health and Welfare, serves as the competent authority responsible for medical device registration, market surveillance, and quality system oversight. The TFDA enforces a robust regulatory regime that, while sharing some similarities with other major markets, has its own unique requirements, classification rules, and approval pathways.<\/span><\/p>\n

Consequently, collaborating with a local partner who possesses deep regulatory expertise and on-the-ground experience is not just beneficial, but often a critical component for achieving efficient and compliant market access.<\/span><\/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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Medical devicesl refer to instruments, machines, apparatus, materials, software, reagents for in vitro use, and related articles thereof, whose design and use achieve one of the following primary intended actions in or on the human body by other than pharmacological, immunological, metabolic, or chemical means:<\/span><\/p>\n

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  • Diagnosis, treatment, alleviation, or direct prevention of human diseases.<\/span><\/li>\n
  • Modification or improvement of the structure and function of human body.<\/span><\/li>\n
  • Control of conception.<\/span><\/li>\n<\/ul>\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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    • Class I devices<\/strong> \u2013<\/strong> Low risk<\/strong>: Medical devices that implements routine management which can ensure their safety and effectiveness.<\/span><\/li>\n
    • Class II medical device<\/strong> \u2013 Moderate risk: <\/strong>Medical devices that requires strict control and management to ensure their safety and effectiveness.<\/span><\/li>\n
    • Class III devices<\/strong> \u2013 High risk<\/strong>: Medical devices that requires special measures to strictly control and manage them to ensure their safety and effectiveness.<\/span><\/li>\n<\/ul>\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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      Type of medical device<\/strong><\/span><\/td>\nThe Registration Pathway<\/strong><\/span><\/td>\nRegulatory Authority<\/strong><\/span><\/td>\n<\/tr>\n
      Class I devices<\/span><\/td>\nListing<\/span><\/td>\nTFDA<\/span><\/td>\n<\/tr>\n
      Class I medical devices fall under the catalog<\/a> published by the TFDA<\/span><\/td>\n\u00b7         Stage 1:<\/u> Quality system documentation (QSD) Registration<\/span>\n

      Except for products exempted from manufacturing licensing requirements as listed in the <\/em>catalog<\/em><\/a> published by the TFDA.<\/em><\/span><\/p>\n

      \u00b7         Stage 2:<\/u> Registration and Market Approval<\/span><\/p><\/td>\n<\/tr>\n

      Class II, III devices<\/span><\/td>\n\u00b7         Stage 1:<\/u> Quality system documentation (QSD) Registration<\/span>\n

      Except for products exempted from manufacturing licensing requirements as listed in the <\/em>catalog<\/em><\/a> published by the TFDA.<\/em><\/span><\/p>\n

      \u00b7         Stage 2:<\/u> Registration and Market Approval<\/span><\/p><\/td>\n<\/tr>\n

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