{"id":2018,"date":"2025-11-24T12:15:25","date_gmt":"2025-11-24T05:15:25","guid":{"rendered":"https:\/\/mednovum.com.vn\/?post_type=dich_vu&p=2018"},"modified":"2025-11-28T18:00:00","modified_gmt":"2025-11-28T11:00:00","slug":"singapore","status":"publish","type":"dich_vu","link":"http:\/\/mednovum.com.vn\/en\/dich-vu\/singapore\/","title":{"rendered":"Singapore"},"content":{"rendered":"

Singapore \u2013 Why should manufacturers consider entering?<\/h2>\n\t
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Singapore is regarded as the most developed medical device market in Southeast Asia, characterized by high demand for advanced healthcare solutions, high-tech equipment and strict quality standards. The government invests heavily in public healthcare and innovation, while the private sector is rapidly expanding premium healthcare services. This makes Singapore an attractive destination for international medical device manufacturers seeking to expand their business operations.<\/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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According to the provisions of the First Schedule of the Health Products Act 2007<\/strong>, \u201cMedical devices<\/em><\/strong>\u201d means:<\/p>\n

(a) là bất kỳ dụng cụ, thiết bị, công cụ, máy móc, vật dụng, vật cấy ghép, thuốc thử dùng trong xét nghiệm in vitro, phần mềm, vật liệu hoặc các sản phẩm tương tự hoặc có liên quan khác được nhà sản xuất chỉ định sử dụng, dù riêng lẻ hay kết hợp, cho con người nhằm một hoặc nhiều mục đích cụ thể sau đây:<\/p>\n

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  • diagnosis, prevention, monitoring, treatment or alleviation of disease;<\/li>\n
  • diagnosis, monitoring, treatment or alleviation of, or compensation for, an injury;<\/li>\n
  • investigation, replacement, modification or support of the anatomy or of a physiological process, mainly for medical purposes;<\/li>\n
  • support or sustaining life;<\/li>\n
  • control of conception;<\/li>\n
  • disinfection of medical devices; or<\/li>\n
  • providing information by means of in-vitro examination of specimens derived from the human body, for medical or diagnostic purposes,<\/li>\n<\/ul>\n

    and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means, and which is not a cell, tissue or gene therapy product; and<\/p>\n

    (b) bao gồm các vật phẩm sau:<\/p>\n

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    • any implant for the modification or fixation of any body part;<\/li>\n
    • any injectable dermal filler or mucous membrane filler;<\/li>\n
    • any instrument, apparatus, implement, machine or appliance intended to be used for the removal or degradation of fat by invasive means.<\/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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      Type<\/strong><\/td>\nRisk level<\/strong><\/td>\n<\/tr>\n
      A<\/td>\nLow risk<\/td>\n<\/tr>\n
      B<\/td>\nLow to moderate risk<\/td>\n<\/tr>\n
      C<\/td>\nModerate to high risk<\/td>\n<\/tr>\n
      D<\/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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      • Regulatory Authority<\/strong>: The Health Sciences Authority (HSA)<\/li>\n
      • The registration and application submission process is carried out through the Singapore Health Product Access and Regulatory E\u2011System <\/em>(SHARE)<\/strong>. To obtain a dealer\u2019s licence and perform medical devices registration, enterprises must first be registered with the Accounting and Corporate Regulatory Authority<\/em> (ACRA)<\/strong> and subsequently create a Client Registration and Identification Service<\/em> (CRIS)<\/strong> with HSA<\/strong>.<\/li>\n
      • The Registration Pathway<\/strong>:<\/li>\n<\/ul>\n

        For Class A medical devices, the registration process is not required. However, the manufacturer or distributor shall submit a notification to the HSA listing the medical devices to be circulated on the market, and must fully comply with other applicable regulatory requirements such as dealer licensing and related obligations.<\/p>\n

        For Class B, C, and D medical devices, the registration process prior to circulation is mandatory, with the following registration routes available:<\/p>\n

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        • Class B<\/em><\/strong>: There are 3 registration routes \u2013 Full, Abridged, and Immediate<\/em><\/strong>.<\/em><\/strong><\/li>\n
        • Class C<\/em><\/strong> There are 4 registered routes \u2013 ull, Abridged, Expedited, and Immediate.<\/em><\/strong>.<\/em><\/strong><\/li>\n
        • Class D<\/em><\/strong>: There are 3 registration routes \u2013 Full, Abridged, and Expedited.<\/em><\/strong>.<\/li>\n<\/ul>\n\n\t\t<\/div>\n\t<\/div>\n<\/div><\/div><\/div><\/div>

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