{"id":2023,"date":"2025-11-24T12:18:57","date_gmt":"2025-11-24T05:18:57","guid":{"rendered":"https:\/\/mednovum.com.vn\/?post_type=dich_vu&p=2023"},"modified":"2025-11-28T16:16:43","modified_gmt":"2025-11-28T09:16:43","slug":"han-quoc","status":"publish","type":"dich_vu","link":"http:\/\/mednovum.com.vn\/en\/dich-vu\/han-quoc\/","title":{"rendered":"Korea"},"content":{"rendered":"

Korea<\/h2>\n\t
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With a market value reaching billions of USD and a stable growth rate, South Korea has become an attractive destination for medical device Owners worldwide. The market share for imported medical devices is expanding, driven by the continuous development of the modern medical infrastructure and system, and the accelerating demand of using high-quality home healthcare medical devices. In addition, the aging population trend and increased health care awareness are providing further momentum for this market. Meanwhile, domestic production is still limited, creating large gap for foregin enterprises. However, entering this promising market encounters significant challenges due to strict regulatory requirements with complex registration and approval procedures. In the face of these vast opportunities, MedNovum is always ready to support and accompany Owners in accessing the South Korean medical device market in a compliant and sustainable manner.<\/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 Article 2 of Medical Device Act, a medical device is defined as follows.<\/p>\n

\"The term \"medical device\" in this Act means an instrument, machine, apparatus, material, software, or any other similar product, specified in the following subparagraphs as one used, alone or in combination, for human beings or animals, provided that drugs and quasi-drugs under the Pharmaceutical Affairs Act, and prosthetic limbs, aids among the assistive devices for persons with disabilities under Article 65 of the Act on Welfare of Persons with Disabilities are excluded here from:<\/p>\n

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  1. A product used for the purpose of diagnosing, curing, alleviating, treating, or preventing a disease;<\/li>\n
  2. A product used for the purpose of diagnosing, curing, alleviating, or correcting an injury or impairment;<\/li>\n
  3. A product used for the purpose of testing, replacing, or transforming a structure or function; or<\/li>\n
  4. A product used for the purpose of contraception.<\/li>\n<\/ol>\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
    I<\/td>\nLow risk<\/td>\n<\/tr>\n
    II<\/td>\nLow to moderate risk<\/td>\n<\/tr>\n
    III<\/td>\nModerate to high risk<\/td>\n<\/tr>\n
    IV<\/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 main regulatory authority for all medical devices circulated in market is the Ministry of Food and Drug Safety (MFDS). For marketing authorization, the subordinate agencies are authorized to carry out licensing depending on the device classification as follows:<\/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