Indonesia moh medical device. Comply with Kemenkes regulations.

Indonesia moh medical device. As a medical equipment market, there are 34,800 health facilities consisting of hospitals, public health centers, clinics and laboratories. avoid risk of medical devices, to HEALTH FACILITY SATUSEHAT DISEASE PREVENTION AND CONTROL PHARMACEUTICALS AND MEDICAL DEVICES INFORMATION HEALTH POLICY INFORMATION PANTAUAN KEJADIAN KRISIS KESEHATAN MINISTRY OF HEALTH RELEASE Medical Devices Industry Medical Devices Mandatory to implement Good Manufacturing Mandatory to implement Good Distribution Practice MD Guidance, which develop by MOH Practice MD Guidance adopted from ISO 13485:2016 A technical responsible person who already A technical responsible person who already has GDP-MD training certificate has GMP-MD training certificate MoH Regulation No. The regulatory framework categorizes medical devices into different classes based on risk, which dictates the regulatory process, registration requirements, and oversight. Nov 28, 2024 · A Comprehensive Guide to Medical Device Registration in Indonesia Introduction Expanding into the Indonesian market with medical devices requires careful navigation of regulatory processes. Oct 6, 2025 · A list of recently published and updated articles regarding medical device regulatory updates from the MOH and other governing bodies in Indonesia. Learn how to register your medical device in Indonesia. 62 of 2017 regarding distribution permits. A notable aspect of this regulatory framework is that products approved by the U. Feb 24, 2025 · Ministry of Health (MoH)Indonesia Medical Device Registration: A Comprehensive Guide Regulatory Authority Ministry of Health (MoH) The Indonesian Ministry of Health (MoH) plays a pivotal role in overseeing the registration process for medical devices and household health supplies within the country. The MoH defines medical devices and oversees their safety, quality, and efficacy. In this HEALTH FACILITY SATUSEHAT DISEASE PREVENTION AND CONTROL PHARMACEUTICALS AND MEDICAL DEVICES INFORMATION HEALTH POLICY INFORMATION PANTAUAN KEJADIAN KRISIS KESEHATAN MINISTRY OF HEALTH RELEASE Aug 25, 2025 · Obtaining a Distribution License for Medical Devices (NIE) issued by the MoH is mandatory to sell medical devices in Indonesia. Regulation MoH No. Moreover, they issue key regulations like MoH Regulation No. Food and Our Regulatory Affairs consultants provide strategic support for manufacturers preparing to register medical devices and in vitro diagnostics (IVDs) with Indonesia’s Ministry of Health (MoH), specifically through the Directorate General of Pharmaceuticals and Medical Devices (Ditjen Farmalkes). We help align your regulatory strategy with Indonesia-specific requirements under Regulation No . Hussein has led complex product registrations with Indonesia’s MoH, BPOM, and CDAKB for IVDs, digital health, and medical devices. With Andaman Medical’s expert MDR solutions, we take the burden off your shoulders by managing the entire process for you. With expertise in market access and compliance, he helps global firms scale across Southeast Asia. From complying with local regulations to monitoring device performance and safety, we ensure your products remain compliant, reliable, and market-ready for long-term Dec 13, 2024 · Dr. S. Indonesia’s Ministry of Health (Kementerian Kesehatan) governs medical device registration, ensuring products meet safety, quality, and performance standards before they can be sold to the public. The medical device registration process in Indonesia is considered relatively quick and cost-effective, especially given the country’s size. Under the new regulation, healthcare facilities of hospitals, local governments or communities are required to allocate a certain amount of budget to carry out medical device maintenance. This new requirement is aimed to Indonesia, with a population exceeding 275 million, is the world's fourth most populous country and a significant market for medical devices, relying heavily on innovative imported products. Comply with Kemenkes regulations. 4 Year 2014 Learn how to register your medical device in Indonesia. Medical devices in Indonesia are primarily regulated by the Ministry of Health (MoH), through its Directorate General of Pharmaceuticals and Medical Devices. Step-by-step guide, classification, cost, and process explained. 14/2021 Devices, In Vitro Diagnostic Medical Devices and PKRT which are produced, imported, assembled and/or repackaged for distribution within the territory of the Republic of Indonesia must have Product License (Registration number) Any Medical Dec 8, 2024 · In Indonesia, medical devices are regulated by the Ministry of Health (MoH), which ensures their safety, efficacy, and quality. Medical and IVD devices must secure a registration number and a product license from the MoH before importation, with these approvals granted to a local, licensed importer or license holder. Article 48 Any used Medical Devices, In Vitro Diagnostic Medical Devices and PKRT, including those reconditioned, refurbished and/or remanufactured are prohibited from being imported, used and/or distributed within the territory of the Republic of Indonesia. Navigating Indonesia’s regulatory landscape for medical device post-market surveillance can be complex. Indonesia consist of five main islands and some 30 smaller archipelagoes, totaling Medical Devices Manufacturers about 18,110 islands and islets with a population of around 270 thousand million people. You must ensure your products comply with approved labeling and packaging requirements and meet specific quality standards. Jul 10, 2024 · On 2 March 2023, Indonesia's Minister of Health enacted Minister of Health Regulation on Maintenance of Medical Devices in Healthcare Facilities ("MOH Regulation 15/2023"). Directorate of Medical Device Production and Distribution Service MINISTRY OF HEALTH REPUBLIC OF INDONESIA to . neuuqw0 yu4gcq crrd pfer htai jtp1awm z5w5 isk qcdn lz9

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