Indonesia's Device Registry: 78K Registrations, 76% Imported, Expiry Cliff
Analysis of Indonesia's Kemenkes device registry reveals 75.8% of registrations are imports (AKL), China supplies 36.5% of imported devices, and 17.2% of all registrations expire in 2026.
Executive Summary
Indonesia's Ministry of Health (Kemenkes) requires every medical device — whether domestically manufactured (AKD) or imported (AKL) — to be registered and issued a Nomor Izin Edar (NIE) before it can be sold. With a population of 275 million, near-universal JKN health insurance coverage, and a medical device market approaching USD 2.8 billion, Indonesia is one of the largest and fastest-growing device markets in Southeast Asia.
Our analysis of the complete Kemenkes device registry (extracted March 2026, 78,787 registration records) reveals a market where 75.8% of registrations are imports and domestic manufacturing accounts for just 24.2%. China supplies 36.5% of all imported devices — more than the US (11.1%) and Germany (11.0%) combined. The top 15 registrants control only 10.8% of registrations, indicating a fragmented but competitive distributor landscape. And a significant expiry cliff looms: 17.2% of all registrations (13,513 products) are set to expire in 2026, with another 24.8% expiring in 2027.
This article quantifies the AKD/AKL split, maps the manufacturer-country origins, identifies registrant concentration, and highlights the expiry cliff that will require coordinated renewal activity across hundreds of registrants.
Data Source and Method
- Source: Indonesia Kemenkes (Ministry of Health) public device registration database
- Analysis sample: Kemenkes registry extract dated March 2026 (78,787 registration records)
- Scope: All active and registered devices (AKD domestic and AKL import)
- Analysis date: 9 June 2026
- Computed using: MedDeviceGuide analysis of the Kemenkes public registry extract
- Limitations: The dataset reflects registrations as of March 2026. Expiry dates represent the registration validity period (typically 2–5 years per Permenkes regulations), not market withdrawal. Registrant names reflect the local Indonesian entity that holds the NIE; for imported devices, this is typically the distributor or Local Authorized Representative (LAR), not the foreign manufacturer. Domestic (AKD) registrations show "Indonesia" as the manufacturer country for 99.7% of entries, confirming near-exclusive domestic manufacturing.
The Kemenkes Registry at a Glance
| Metric | Value |
|---|---|
| Total registrations | 78,787 |
| Imported (AKL) | 59,709 (75.8%) |
| Domestic (AKD) | 19,078 (24.2%) |
| Unique registrants | ~4,000+ |
| Unique manufacturer countries | ~55+ |
Indonesia's import dependency is evident: three out of four registered devices are imported. This is consistent with the country's medical device market structure, where high-end equipment (MRI, CT, surgical robots, advanced diagnostics) is overwhelmingly sourced from abroad, while domestic manufacturing focuses on consumables, basic hospital furniture, and personal protective equipment.
Device Class Distribution
Indonesia follows the ASEAN Medical Device Directive (AMDD) risk-based classification:
| Device Class | Registrations | Share |
|---|---|---|
| Class B | 35,561 | 45.1% |
| Class A | 24,593 | 31.2% |
| Class C | 16,110 | 20.4% |
| Class D | 2,521 | 3.2% |
| Unspecified | 2 | 0.0% |
Class B (low-to-moderate risk) dominates at 45.1%, followed by Class A (low risk) at 31.2%. Class D (high risk) accounts for only 3.2%, consistent with the smaller number of high-risk implantable and life-sustaining devices in any market. This distribution is broadly similar to other ASEAN registries.
The AKD vs. AKL Split: Domestic Manufacturing Has a Long Way to Go
| Registration Type | Count | Share |
|---|---|---|
| AKL (Imported — Alat Kesehatan Luar) | 59,709 | 75.8% |
| AKD (Domestic — Alat Kesehatan Dalam) | 19,078 | 24.2% |
Despite Indonesia's TKDN (Tingkat Komponen Dalam Negeri — Domestic Component Level) policy, which has reduced the share of imported products in government e-catalogues from 92% to 52% since 2022, the registration data shows that domestic manufacturing still accounts for only about one in four registered devices. The Indonesian government reported 16,777 locally produced and 56,325 imported medical devices listed by the Ministry of Health as of 2025 — figures broadly consistent with the AKD/AKL split in our dataset.
Domestic production is concentrated in:
- Basic hospital supplies (beds, furniture)
- Personal protective equipment (gloves, masks, gowns)
- Simple surgical instruments
- Basic diagnostic consumables
High-end equipment — MRI, PET-CT, linear accelerators, ventilators, surgical robots — continues to be imported.
Manufacturer Country Origins: China Dominates Imports
Overall Manufacturer Country Ranking
| Rank | Country | Registrations | Share | Cumulative |
|---|---|---|---|---|
| 1 | China | 21,813 | 27.7% | 27.7% |
| 2 | Indonesia | 19,046 | 24.2% | 51.9% |
| 3 | United States | 6,649 | 8.4% | 60.3% |
| 4 | Germany | 6,594 | 8.4% | 68.7% |
| 5 | South Korea | 3,454 | 4.4% | 73.1% |
| 6 | Japan | 2,365 | 3.0% | 76.1% |
| 7 | India | 1,952 | 2.5% | 78.5% |
| 8 | Italy | 1,812 | 2.3% | 80.8% |
| 9 | France | 1,280 | 1.6% | 82.5% |
| 10 | United Kingdom | 1,174 | 1.5% | 83.9% |
| 11 | Pakistan | 955 | 1.2% | 85.2% |
| 12 | Taiwan | 952 | 1.2% | 86.4% |
| 13 | Turkey | 922 | 1.2% | 87.5% |
| 14 | Spain | 879 | 1.1% | 88.7% |
| 15 | Switzerland | 861 | 1.1% | 89.7% |
China is the single largest source country overall (27.7%) and within imports specifically. Indonesia's 24.2% share reflects domestic manufacturing. The US and Germany each contribute approximately 8.4%, with South Korea (4.4%) and Japan (3.0%) rounding out the top six.
Import-Only Country Ranking (AKL)
| Rank | Country | Registrations | Share (of AKL) | Cumulative |
|---|---|---|---|---|
| 1 | China | 21,813 | 36.5% | 36.5% |
| 2 | United States | 6,649 | 11.1% | 47.7% |
| 3 | Germany | 6,594 | 11.0% | 58.7% |
| 4 | South Korea | 3,454 | 5.8% | 64.5% |
| 5 | Japan | 2,365 | 4.0% | 68.5% |
| 6 | India | 1,952 | 3.3% | 71.7% |
| 7 | Italy | 1,812 | 3.0% | 74.8% |
| 8 | France | 1,280 | 2.1% | 76.9% |
| 9 | United Kingdom | 1,174 | 2.0% | 78.9% |
| 10 | Pakistan | 955 | 1.6% | 80.5% |
China alone supplies more imported devices than the US and Germany combined (21,813 vs. 13,243). The top 10 import-source countries account for 80.5% of all AKL registrations, showing moderate geographic concentration.
Domestic Manufacturing (AKD)
| Country | Registrations | Share |
|---|---|---|
| Indonesia | 19,025 | 99.7% |
| Other/unspecified | 53 | 0.3% |
As expected, domestic registrations are overwhelmingly (99.7%) manufactured in Indonesia.
Registrant Concentration: Top 15 Hold 10.8%
The registrant is the Indonesian legal entity that holds the NIE (marketing authorization). For imports, this is the distributor or LAR; for domestic products, it is the manufacturer.
| Rank | Registrant | Products | Share | Cumulative |
|---|---|---|---|---|
| 1 | PT Roche Indonesia | 997 | 1.3% | 1.3% |
| 2 | PT Abbott Products Indonesia | 881 | 1.1% | 2.4% |
| 3 | PT Mindray Medical Indonesia | 867 | 1.1% | 3.5% |
| 4 | PT Enseval Medika Prima | 610 | 0.8% | 4.3% |
| 5 | PT Medtronic Indonesia | 607 | 0.8% | 5.0% |
| 6 | PT Siemens Healthineers Indonesia | 549 | 0.7% | 5.7% |
| 7 | PT Johnson and Johnson Indonesia Two | 462 | 0.6% | 6.3% |
| 8 | PT B. Braun Medical Indonesia | 460 | 0.6% | 6.9% |
| 9 | PT Intisumber Hasil Sempurna Global | 459 | 0.6% | 7.5% |
| 10 | PT Tawada Healthcare | 457 | 0.6% | 8.1% |
| 11 | PT Endo Indonesia | 452 | 0.6% | 8.6% |
| 12 | PT Mega Pratama Medicalindo | 445 | 0.6% | 9.2% |
| 13 | PT Jayamas Medica Industri Tbk | 429 | 0.5% | 9.7% |
| 14 | PT Thomasong Nirmala | 421 | 0.5% | 10.3% |
| 15 | PT Setia Anugrah Medika | 406 | 0.5% | 10.8% |
The registrant landscape is highly fragmented: the top 15 registrants control only 10.8% of all products. PT Roche Indonesia leads with 997 registered products — a portfolio dominated by IVD reagents and diagnostic systems. PT Abbott Products Indonesia (881) and PT Mindray Medical Indonesia (867) round out the top three.
Among the top 15, several are Indonesian-owned distributors (PT Enseval Medika Prima, PT Intisumber Hasil Sempurna Global, PT Tawada Healthcare, PT Thomasong Nirmala) that aggregate products from multiple foreign manufacturers, while others are local subsidiaries of multinational device companies (Roche, Abbott, Medtronic, Siemens, J&J, B. Braun).
The Expiry Cliff: 17.2% of Registrations Expire in 2026
Indonesian device registrations have a validity period of 2 to 5 years (per Permenkes regulations). The expiry date distribution reveals a significant concentration:
| Expiry Year | Registrations | Share |
|---|---|---|
| 2026 | 13,513 | 17.2% |
| 2027 | 19,546 | 24.8% |
| 2028 | 18,269 | 23.2% |
| 2029 | 14,869 | 18.9% |
| 2030 | 11,968 | 15.2% |
| 2031+ | 622 | 0.8% |
42.0% of all registrations (33,059 products) expire in 2026 or 2027. This creates a massive renewal workload for both registrants and Kemenkes:
- Registrants must file renewal applications with updated documentation (CSDT dossier, quality system evidence, Halal/BPJPH compliance status if applicable)
- Kemenkes must process renewal applications within revised timelines under Permenkes No. 11 of 2025 (3–4 months for renewals, up from the previous 1–2 months)
- Failure to renew before expiry means the product cannot legally be sold, disrupting both commercial operations and hospital supply chains
Monthly Expiry Concentration
The heaviest expiry months are:
| Month | Expiring Registrations |
|---|---|
| December 2026 | 3,120 |
| December 2027 | 3,152 |
| February 2028 | 2,197 |
| December 2028 | 2,233 |
The December clustering suggests that many registrations were originally approved or renewed in December (consistent with end-of-year filing patterns), creating recurring December expiry peaks. Registrants with large portfolios expiring in December 2026 should begin renewal preparation no later than Q3 2026 to avoid processing bottlenecks.
Top Product Categories
| Category | Registrations | Share |
|---|---|---|
| Peralatan Bedah (Surgical Equipment) | 9,914 | 12.6% |
| Sistem Tes Kimia Klinik (Clinical Chemistry Test Systems) | 8,061 | 10.2% |
| Peralatan Rumah Sakit Umum (General Hospital Equipment) | 5,331 | 6.8% |
| Peralatan Rumah Sakit Umum Lainnya (Other General Hospital Equipment) | 4,369 | 5.5% |
| Peralatan Anestesi Terapetik (Therapeutic Anesthesia Equipment) | 2,947 | 3.7% |
| Peralatan Radiologi Diagnostik (Diagnostic Radiology) | 2,384 | 3.0% |
| Pereaksi Serologi (Serology Reagents) | 2,154 | 2.7% |
| Sistem Tes Imunologikal (Immunological Test Systems) | 2,017 | 2.6% |
| Peralatan Mata Terapetik (Therapeutic Eye Equipment) | 2,000 | 2.5% |
| Peralatan Kesehatan Fisik Prostetik (Physical Prosthetics) | 1,813 | 2.3% |
Surgical equipment leads at 12.6%, followed closely by clinical chemistry test systems (10.2%) — reflecting Indonesia's significant investment in diagnostic laboratory infrastructure. Together, the top 10 categories account for approximately 52% of all registrations, with the remaining 48% spread across dozens of smaller categories.
Practical Implications
1. The 2026–2027 Expiry Cliff Demands Early Renewal Planning
With 13,513 registrations expiring in 2026 and 19,546 in 2027, registrants and their LAR partners must plan renewal submissions well in advance. Under Permenkes No. 11 of 2025, renewal processing now takes 3–4 months (up from 1–2 months previously), meaning applications for December 2026 expiries should ideally be filed by August–September 2026. LARs managing large portfolios should batch renewal filings to avoid overwhelming their regulatory affairs teams.
2. China's Dominance Creates Supply Chain Concentration
China's 36.5% share of imported devices means that any disruption to Sino-Indonesian trade — whether from regulatory actions, customs policy changes, or geopolitical tensions — could affect more than one-third of Indonesia's imported device supply. Manufacturers and distributors should diversify sourcing where possible and maintain safety stock for critical Chinese-sourced products.
3. Domestic Manufacturing Opportunity
With AKD registrations at only 24.2% and the TKDN policy actively pushing for higher domestic content, there is a clear opportunity for manufacturers willing to establish local production. The Indonesian government's SIHREN, SOPHI, and InPULS initiatives (totaling approximately USD 4 billion) are designed to accelerate local manufacturing capacity. However, domestic production currently concentrates on low-value products; the real opportunity is in medium-complexity devices (Class B/C) where Indonesia still relies heavily on imports.
4. LAR/Distributor Selection Remains Critical
The fragmented registrant landscape (top 15 at only 10.8%) means there are many choices for LAR/distributor partners. However, the expiry cliff amplifies the importance of choosing an LAR with demonstrated renewal management capability. An LAR that fails to manage timely renewals can take an entire product portfolio offline — a risk that is acute in 2026–2027.
Source Notes
- Data source: Indonesia Kemenkes (Ministry of Health) public device registration database; analysis by MedDeviceGuide, run date 2026-06-09.
- Analysis sample: Kemenkes registry extract dated March 2026, 78,787 registration records.
- Classification system: ASEAN Medical Device Directive (AMDD) risk classes A through D.
- Regulatory basis: Permenkes No. 62 of 2017 (product licensing), Permenkes No. 11 of 2025 (revised timelines), CSDT format per AMDD alignment.
- Market size: Approximately USD 2.78 billion (2025 estimate, U.S. Commercial Service Indonesia).
- AKL/AKD: AKL (Alat Kesehatan Luar) = imported devices; AKD (Alat Kesehatan Dalam) = domestically manufactured devices.