{"id":1956,"date":"2025-11-20T16:47:38","date_gmt":"2025-11-20T09:47:38","guid":{"rendered":"https:\/\/mednovum.com.vn\/?post_type=dich_vu&p=1956"},"modified":"2025-11-28T16:39:15","modified_gmt":"2025-11-28T09:39:15","slug":"indonesia","status":"publish","type":"dich_vu","link":"http:\/\/mednovum.com.vn\/en\/dich-vu\/indonesia\/","title":{"rendered":"Indonesia"},"content":{"rendered":"

Indonesia \u2013 A Breakthrough Market for the Medical Device Industry in Southeast Asia<\/h2>\n\t
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With a population of more than 270 million people, Indonesia is seeing a strong increase in demand for good-quality medical devices. The government is putting a lot of effort and money into improving hospitals, clinics, and public health centers. It is also making it easier to import medical devices and encouraging international partnerships in the healthcare field. From diagnostic and testing devices to imaging, treatment, and home-care equipment, Indonesia needs a steady and reliable supply of modern, high-standard medical devices.<\/p>\n

This is a great chance for medical device manufacturers to grow their business, explore new opportunities, and take part in Indonesia\u2019s healthcare improvement process. Investing in this market is not only about trade\u2014it is also a long-term step to build a stronger position in one of the fastest-growing healthcare markets in Southeast Asia.<\/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 devices<\/strong> refers to instruments, equipment, machines, and\/or implantable devices that do not contain medicinal substances, used for the prevention, diagnosis, treatment, and alleviation of diseases, treatment of patients, restoration of human health, and\/or construction and improvement of body structure and functions. (Article 1.1 Permenkes Number 1189<\/em><\/strong>)<\/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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  • Registrasi Alat Kesehatan & PKRT Online<\/li>\n
  • Registration process<\/li>\n<\/ul>\n\n\n\n\n\n\n\n
    Fertilizer<\/strong> Classification<\/strong><\/td>\nEvaluation time (days)<\/strong><\/td>\nTimeline<\/strong> licensing period<\/strong><\/td>\nTimeline<\/strong> additional time (days)<\/strong><\/td>\nFight<\/strong> second price<\/strong><\/td>\nTimeline<\/strong><\/td>\n<\/tr>\n
    A<\/td>\n10<\/td>\nWithin 10 days from the date the evaluation is completed<\/td>\n10<\/td>\nWithin 10 days from the date of receipt of the complete application<\/td>\nWithin 10 days from the date the evaluation is completed<\/td>\n<\/tr>\n
    B<\/td>\n20<\/td>\n10<\/td>\n<\/tr>\n
    C<\/td>\n20<\/td>\n10<\/td>\n<\/tr>\n
    D<\/td>\n30<\/td>\n15<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\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