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Indonesia Ministry of Health (MoH)
The Indonesia Ministry of Health (MoH) functions as the country’s central regulatory body, overseeing the nation’s medical device industry. It is located in Jakarta. Prior to the creation of the MoH, the Ministry of Social Affairs initially assumed responsibility for public health programs. It was founded in 1946 following Indonesian Independence. By 1966, the Ministry of Health had been established as a separate entity, signaling a greater emphasis on public health in the country after that point. The website for the Indonesia MoH can be accessed here.
Recent History of the Indonesia MoH
Throughout the 20th century, the Ministry of Health worked towards expanding and improving the country’s healthcare infrastructure. It prioritized the establishment of hospitals, health centers, and clinics across the nation, particularly in rural and remote areas with limited access to healthcare services.
This expansion aimed to bridge the healthcare gap and enhance the delivery of primary healthcare to all Indonesians. To ensure the provision of high-quality healthcare services, the Ministry of Health regulates and monitors healthcare providers and facilities across the country.
The Indonesia Ministry of Health has evolved over the course of the 2000s and 2010s. The organization is currently in charge of pre-market and post-market evaluation, standardization, legislation and Good Manufacturing Practices (GMP) certification.
Recent updates include the formulation of guidelines and protocols for managing COVID-19 cases, healthcare facility regulations, and telemedicine services.
The Indonesia MoH has also put into place the “Good Method of Distribution of Medical Devices,” or CDAKB, which is a series of guidelines put in place to standardize quality control across the Indonesian medical device market.
Significant Recent MoH Updates
There have been a number of significant recent updates from the Indonesia MoH. Currently, medical device classification in Indonesia closely follows GHTF Classification guidelines and are being harmonized according to the ASEAN Medical Devices Directive with four classes A, B, C and D, ranked from low to high-risk categorization.
Another important recent update from the Indonesia MoH is the implementation of their Government e-Catalogue (or e-Katalog), an online purchasing system that was established to create transparency and prevent corruption in government purchases, including in public hospitals. The service was initially launched in 2013 and has steadily expanded since then. The e-Catalogue can be accessed here.
Several important changes have been made to the government portal since then. Previously, the Indonesian Government Goods and Services Procurement Organization (LKPP) oversaw the e-Catalogue and required manufacturers meet and justify their pricing prior to listing a product on the website. Under the new rules, oversight of the e-Catalogue has been moved under the Ministry of Health and will not require negotiations.
Recent Blogs on Indonesia
More Information on Indonesia MoH Regulatory Requirements for Medical Devices
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Contact Asia Actual if you have any questions and/or would like to learn more about accessing the Indonesia market specific to your product portfolio.
Asia Actual is a regulatory consulting company specializing in helping manufacturers grow their sales through independent license holding, direct fulfillment, and a variety of sales channel support services.
Indonesia Regulatory Support
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