Indonesia’s healthcare market is rapidly expanding, and American medtech firms are moving in. In fact, Indonesia’s fourth-largest population has prompted healthcare reforms that greatly increase demand for modern devices. The U.S. Embassy notes that “American medical devices, diagnostic equipment, and medicines are helping healthcare providers deliver the best care possible” in Indonesia[1]. However, success requires navigating complex regulations and mastering the Indonesian Ministry of Health’s online registration system – the MoH “Regalkes” portal, often called the product registration Indonesia website – to gain timely market access.

Indonesia’s Regulatory Framework and the MoH Portal

Medical devices in Indonesia are regulated by the Ministry of Health (MoH). Under MoH Regulation No. 62/2017, every device must obtain a Nomor Izin Edar (NIE) registration number before import or sale[2]. Registrations follow the ASEAN Common Submission Dossier Template (CSDT), meaning companies should prepare dossiers in the standardized ASEAN format[3]. In practice, having FDA clearance or CE marking is helpful but not sufficient – the Indonesian guidelines require translation of all labels and Instructions for Use into Bahasa Indonesia, notarization of foreign certificates (e.g. Certificate of Free Sale, GMP, or Letter of Authorization), and submission of localized technical files[4]. In short, U.S. firms must adapt global documentation to Indonesian rules.

The Ministry of Health’s online Regalkes portal is the core digital platform for all medical device registrations[5]. All submissions, fees, and correspondence are handled through the Regalkes system. The Regalkes portal (regalkes.kemkes.go.id) provides a structured workflow: companies upload dossiers, respond to MoH clarification requests, and receive NIE approvals online[5][6]. Because the interface is in Bahasa Indonesia and has strict naming conventions, many U.S. firms work closely with local regulatory consultants. Indeed, step-by-step guides on sites like ProductRegistrationIndonesia.com explain how to navigate this product registration Indonesia website end-to-end[2]. In practice, a foreign manufacturer must appoint a local representative (with a valid Izin Distribusi Alat Kesehatan, or IDAK license), supply an embassy-legalized Letter of Authorization and Certificate of Free Sale, and ensure the local distributor holds the required Good Distribution Practice certificate (CDAKB)[7][8]. Notably, as of July 2024 the MoH enforces CDAKB certification – distributors cannot complete a new device registration without it[7].

Leveraging Regulatory Intelligence

Regulatory expertise and intelligence are key for U.S. companies. One advantage is leveraging existing approvals. For example, under recent trade commitments Indonesia agreed to accept U.S. FDA certificates and prior authorizations for medical devices[9]. In practice, this means a firm can include its FDA 510(k) or PMA documentation in the Regalkes dossier, then supplement with the ASEAN CSDT structure. Indeed, Indonesia’s guidelines align with the ASEAN Medical Device Directive, but still require local translations and adaptations[3]. By preparing dossiers in advance according to ASEAN CSDT and having CE/FDA docs ready to legalize, companies avoid redundant testing and shorten review times.

Another example of regulatory intelligence is monitoring Indonesia’s TKDN (local content) policies. Indonesian law often favors products with high Domestic Component Level (TKDN). However, bilateral agreements have begun to ease these requirements for U.S. imports. In mid-2025, Coordinating Minister Airlangga Hartarto announced that certain U.S. medical device components will be exempted from TKDN rules[10]. In plain terms, select American-made medical products can bypass strict local content quotas when registering in Indonesia, provided they meet other regulatory requirements (such as MoH safety standards). This reflects a broader shift – during the COVID-19 emergency, Indonesia accelerated approvals for U.S. products by accepting FDA and WHO/USP certifications (e.g. AstraZeneca and Pfizer vaccines were approved based on FDA and WHO data[11]).

Likewise, savvy firms ensure compliance with Indonesia’s new distribution rules. The MoH now requires distributors to obtain an official Good Distribution Practice (CDAKB) certificate before any device can be registered[7]. In practical terms, U.S. exporters should vet their Indonesian partners for CDAKB and IDAK licenses up front. They should also prepare quality control and packaging procedures to satisfy Indonesian standards. Consulting the detailed checklists on resources like ProductRegistrationIndonesia.com helps ensure no paperwork gaps[7][8].

Impact of U.S.–Indonesia Trade Policies

Recent U.S. trade policies have significantly affected market access for medical equipment. In 2025 the Trump administration announced a “reciprocal trade deal” whereby the U.S. would impose a flat 19% tariff on Indonesian exports while eliminating tariffs on nearly all U.S. exports to Indonesia[12][13]. President Trump himself declared that under the agreement “They are going to pay 19% and we are going to pay nothing – we will have full access into Indonesia”[13]. In other words, American-made medical devices now effectively enter Indonesia tariff-free under this deal. Official fact sheets confirm Indonesia will remove tariff barriers on over 99% of U.S. products, explicitly including health and medical products[12].

These trade moves also targeted non-tariff hurdles. The U.S. extract of the agreement states that Indonesia agreed to accept FDA certifications and eliminate burdensome labeling requirements on cosmetics and medical devices[9]. Likewise, the Indonesian side negotiated the relaxation of its onerous TKDN and import licensing requirements for U.S. goods[10]. In tandem, Indonesia’s economic ministers have indicated ongoing negotiations to cut key tariffs “below 19% and potentially down to zero” on strategic imports[14].

Prior to these deals, the Indonesian industry had faced U.S.-imposed tariffs on its exports. Indonesian media point out that under Trump’s previous tariff lists, U.S. duties on Indonesian goods peaked at 32%[15] (versus 19% in the new deal). Industry groups warned that U.S. actions specifically cited Indonesia’s TKDN rules as a non-tariff barrier[15]. On balance, however, the current bilateral agreement liberates American exporters of medical devices: Indonesian tariffs are gone and regulatory recognition has improved. As one U.S. trade article notes, “Indonesian producers do not have to withstand burdensome new testing for FDA-approved products,” reflecting the new acceptance of U.S. standards[9][13].

Case Study: U.S.–Indonesia CT Scanner Collaboration

A concrete success story is the U.S. firm GE Healthcare partnering locally. In June 2025 GE HealthCare, in collaboration with Indonesian pharmaceutical giant PT Kalbe Farma, opened Indonesia’s first CT scanner assembly plant[16]. The Bogor-based facility allows GE to assemble advanced CT diagnostic machines locally, meeting Jakarta’s push for domestic production of key medical devices. GE’s CEO stated the new plant “will help us respond faster to local needs while maintaining the highest international standards of quality and safety”[17]. Kalbe’s management highlighted that the joint venture supports Indonesia’s national health resilience and reduces dependence on imports[17]. The facility is expected to “reduce reliance on imports, shorten delivery times, and support job creation” while boosting local tech capabilities[17]. Indonesian press confirms the investment (about IDR 260 billion) and notes that GE engineers will train local workers in CT scan assembly[18].

Beyond GE, many major U.S. medical technology players have a growing presence. For example, U.S.-origin devices already account for roughly 10% of Indonesia’s medical imports[19]. Global leaders like Medtronic, Becton Dickinson, Abbott, and Johnson & Johnson supply advanced equipment to Indonesian hospitals, and have long-term distributors in Jakarta and regional offices. These companies have gradually expanded by engaging local partners to meet Indonesian rules. The GE/Kalbe CT project exemplifies the kind of joint venture that adapts to Indonesia’s Domestic Component (TKDN) policy while bringing U.S. innovation onshore[16][20].

Strategic Tips for U.S. Companies Entering Indonesia

• Master the Regalkes portal. The MoH’s product registration Indonesia website (regalkes.kemkes.go.id) is the gateway for approvals. Prepare all documents in advance: use the ASEAN CSDT format with Indonesian-language labels and complete the Regalkes e-forms carefully[4][5]. Consider consulting experts (e.g. ProductRegistrationIndonesia.com) to navigate the Bahasa portal interface.
• Leverage FDA/CE approvals. Include existing U.S. FDA 510(k)/PMA or CE certificates in your dossier. Under the new trade agreement, Indonesian authorities will honor those certifications[9]. Still, be ready to address any local data or labeling requirements (such as translations) that MoH may ask for.
• Partner with a compliant local agent. Your Indonesian distributor must hold an IDAK distribution license and the new Good Distribution Practice (CDAKB) certificate[7][8]. Verify these upfront. A well-connected agent can also advise on market entry and help with Bureaucracy (DPMPTSP permits, customs, etc.).
• Monitor TKDN and procurement rules. Track regulatory bulletins (e.g. on kemkes.go.id and trade.gov) for TKDN updates. If a local-content requirement applies, consider local assembly or components to achieve the threshold. Otherwise, apply for TKDN exemptions now available to U.S. firms[10]. Also explore Indonesia’s government procurement channels (e-Katalog) and prep for e-tenders with transparent pricing strategies.
• Use trade deal benefits. Remember that U.S. medical devices now enter tariff-free[12][13]. Take advantage of eliminated import duties to price competitively. Highlight in marketing that your products meet U.S. standards recognized by Indonesia – this can reassure Indonesian buyers.
• Stay engaged with regulatory changes. Indonesia frequently updates medical device rules (e.g. halal certification deadlines, Medical Device Act revisions). Regularly review official sources and consider membership in ASPAKI (the Indonesian Medical Devices Association) or contact the U.S. Commercial Service in Jakarta for latest alerts.

By combining deep regulatory know-how with a focus on the official product registration Indonesia website, U.S. companies can greatly streamline their entry. In practice, American device makers that prepare complete ASEAN-format dossiers, leverage FDA clearances, and work through the Regalkes portal have seen faster approvals. For example, using the FDA-approved basis allowed urgent imports of COVID-related equipment, and now similarly expedites regular device entries. With the new trade policies and local reforms in place, U.S. firms that invest in regulatory compliance and local partnerships are winning contracts across Indonesia’s hospitals and clinics.

Conclusion: Indonesia’s medical device sector is on the rise, and the regulatory landscape is evolving to favor compliant U.S. exporters. Success stories like GE’s CT scanner JV demonstrate that understanding the rules – and mastering the MoH’s product registration Indonesia website – pays off. U.S. companies planning to register devices in Indonesia should focus on regulatory intelligence: follow Ministry of Health guidelines, use the Regalkes portal effectively, and leverage the benefits of new trade commitments. By doing so, exporters can achieve smooth registrations, gain tariff-free market access, and ultimately help deliver advanced medical care throughout Indonesia.

Sources: Official government and news reports[12][21][10][2][16][18][19][15][13]. Relevant regulatory guidance is summarized on sites like ProductRegistrationIndonesia.com[2][5] and the U.S. Trade Dept. (trade.gov) country reports[22]. (See also kemkes.go.id and trade.gov for official updates.)

[1] The Road to Trade Winds ASEAN: Indonesia
https://www.trade.gov/feature-article/road-trade-winds-asean-indonesia

[2] [3] [4] [5] [6] [7] [8] Indonesia’s Medical Device Registration Guidelines: Step-by-Step Guide – Product registration Indonesia
https://productregistrationindonesia.com/indonesias-medical-device-registration-guidelines-step-by-step-guide/

[9] [12] Fact Sheet: The United States and Indonesia Reach Historic Trade Deal – The White House
https://www.whitehouse.gov/fact-sheets/2025/07/fact-sheet-the-united-states-and-indonesia-reach-historic-trade-deal

[10] [11] [14] Indonesia eases TKDN rules for select US tech, medical imports – ANTARA News
https://en.antaranews.com/news/368689/indonesia-eases-tkdn-rules-for-select-us-tech-medical-imports

[13] Trump sets 19% tariff on Indonesia goods in latest deal, EU readies retaliation | Reuters
https://www.reuters.com/business/autos-transportation/us-planes-cars-drinks-eu-list-potential-tariffs-2025-07-15

[15] [20] Made in Indonesia: Medical Devices Sector Poised for Global Reach
https://business-indonesia.org/news/made-in-indonesia-medical-devices-sector-poised-for-global-reach

[16] [17] Kalbe and GE HealthCare Open Indonesia’s First CT Scanner Manufacturing Facility | The Healthcare Technology Report.
https://thehealthcaretechnologyreport.com/kalbe-and-ge-healthcare-open-indonesias-first-ct-scanner-manufacturing-facility/

[18] KLBF subsidiary partners with GE HealthCare to produce local CT scans | IDNFinancials
https://www.idnfinancials.com/news/54959/klbf-subsidiary-partners-with-ge-healthcare-to-produce-local-ct-scans

[19] Healthcare Resource Guide – Indonesia
https://www.trade.gov/healthcare-resource-guide-indonesia

[21] US-Indonesia trade agreement sets 0% tariffs vs Indonesia’s 19% rate | Fox Business
https://www.foxbusiness.com/politics/trump-announces-huge-win-american-businesses-landmark-indonesia-trade-deal-eliminates-barriers

[22] Indonesia – Healthcare (Medical Devices & Equipment)
https://www.trade.gov/country-commercial-guides/indonesia-healthcare-medical-devices-equipment