{"id":2022,"date":"2025-11-24T12:18:28","date_gmt":"2025-11-24T05:18:28","guid":{"rendered":"https:\/\/mednovum.com.vn\/?post_type=dich_vu&p=2022"},"modified":"2025-11-28T17:41:06","modified_gmt":"2025-11-28T10:41:06","slug":"nhat-ban","status":"publish","type":"dich_vu","link":"http:\/\/mednovum.com.vn\/en\/dich-vu\/japan\/","title":{"rendered":"Japan"},"content":{"rendered":"

JAPAN<\/h2>\n\t
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Japan is one of the countries with the most advanced healthcare systems in the world. It sets high standards for quality, safety, and technology in medical devices. With a rapidly aging population, high healthcare spending, and strong government support for health, the demand for new and better medical equipment in Japan keeps growing. From diagnostic devices, patient monitoring tools, and consumables to treatment support technologies, the Japanese market always looks for products that meet international standards, are accurate, and work well.<\/p>\n

For businesses in the region, partnering with or investing in Japan not only gives access to a modern healthcare system but also helps build a strong reputation in the global medical device market. This is a premium market where truly high-quality products are recognized and valued.<\/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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Devices or instruments, etc., used for the diagnosis, treatment, or prevention of diseases in humans or animals, or intended to affect the structure or function of the human or animal body (excluding regenerative medical products), as specified by Cabinet Order. (Article 2.4 <\/em>Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act))<\/em>)<\/em><\/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
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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Management agency:<\/strong><\/p>\n

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  • Ministry of Health, Labour and Welfare<\/strong><\/li>\n
  • Pharmaceuticals and Medical Devices Agency<\/strong><\/li>\n<\/ul>\n

    Registration process:<\/strong><\/p>\n

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    • Class I:<\/strong> Notification procedure<\/li>\n
    • Class II\/III without certification standards:<\/strong> Submit application to a designed certification body (RCB) (certification)<\/li>\n
    • Class II\/III without certification standards:<\/strong> Requires approval from MHLW via PMDA<\/li>\n
    • Class IV:<\/strong> Mandatory approval from MHLW<\/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