KBLI 26602★ Gold-Tier Intel
Electromedical & Electrotherapy Equipment
Industri Peralatan Elektromedik dan Elektroterapi
🏭 Section C — Manufacturing
In Bali: open to a PT PMA
✅Open· 100% ForeignMedium-High RiskDirect MatchRegistrable in Bali· medium conf.
This classification entails the manufacturing of electromedical and electrotherapeutic equipment—devices used for medical diagnostics and treatment. It covers producing ECG machines, eye testing equipment, oxygen therapy machines, MRI and ultrasound (USG) scanners, medical lasers, hearing aids, pacemakers, and medical ventilators.
Licensing & Requirements
What You Need
Risk LevelMedium-High (Menengah Tinggi)
License TypeNIB + Sertifikat Standar
Processing7 working days
Foreign Ownership100% Open
AuthorityBKPM / OSS
PP28/2025 Licensing Data8 scales
Business scale:
MikroMedium-High RiskNIB + Sertifikat Standar⏱ 7Fiktif Positif
Requirements (Indonesian)7
1Memiliki dokumen rencana penggunaan jenis, spesifikasi, jumlah, dan asal dari bahan baku, serta sumber dan jumlah/ besaran dari energi dan air baku, yang dibutuhkan untuk menjalankan kegiatan usaha industri dalam 1 (satu) siklus produksi atau selama lamanya 6 (enam) bulan ke depan
2Memiliki dokumen berupa: a. Spesifikasi mesin dan/atau daftar peralatan b. Foto mesin/ peralatan; dan c. Perjanjian jual beli/sewa yang membuktikan: 1) Penguasaan (kepemilikan/ sewa) mesin untuk menghasilkan produk industri alat kesehatan serta peralatan pengujian kualitas produk 2) Kesesuaian kapasitas produksi terpasang pada data usaha
3Memiliki dokumen bagan alur: a. Pengadaan, penerimaan, penyimpanan bahan baku, b. Proses produksi c. Proses quality control d. Pengemasan, penyimpanan, pengangkutan dan distribusi hasil produksi
4Memiliki dokumen perencanaan tata letak Fasilitas pabrik/ plant layout facilities sesuai dengan bagan alur proses dan membuktikan tersedianya bangunan fisik sekurangkurangnya berupa: a. Ruang penerimaan dan penyimpanan bahan baku b. Ruang penyimpanan hasil produksi
5Fasilitas pengelolaan limbah
6Memiliki dokumen perjanjian kerja yang membuktikan kepemilikan karyawan yang bekerja sebagai Penanggung Jawab Teknis (PJT) Alat Kesehatan
7Memiliki Surat Pernyataan Komitmen Pemenuhan Cara Pembuatan yang Baik (CPB) untuk Alat Kesehatan
Post-License Obligations4
Memiliki bukti penyampaian wajib Data Industri tervalidasi setiap 6 (enam) bulan sekali sesuai peraturan perundang undangan di bidang perindustrian
Menjamin keamanan dan keselamatan alat, proses, hasil produksi, penyimpanan, serta pengangkutan, sesuai peraturan perundang undangan
Memiliki dokumen hasil kalibrasi peralatan quality control secara periodik atau hasil uji laboratorium independen atas produk yang dihasilkan secara periodik
Memiliki paling sedikit 1 (satu) orang Penanggung Jawab Teknis yang memiliki sertifikat pelatihan Cara Pembuatan yang Baik (CPB) untuk Alat Kesehatan
1
Company incorporation— PT PMDN / CV / Perorangan (local, WNI) — notary deed, AHU registration
2
NIB via OSS— register on oss.go.id, select this code, issued automatically (1–3 days)
3
NIB + Standard Certificate (Small, Medium-High risk)— Authority: Bupati/Walikota — 7 hari
4
NIB + Standard Certificate (Medium, Medium-High risk)— Authority: Bupati/Walikota Gubernur — 7 Hari
5
NIB + Business License (Izin) (Large, High risk)— Authority: Gubernur — 7 hari
6
Submit industrial data report every 6 months (Kemenperin)— post-license obligation
7
Menjamin keamanan dan keselamatan alat, proses, hasil produksi, penyimpanan, serta pengangkutan, ses...— post-license obligation
8
Memiliki dokumen hasil kalibrasi peralatan quality control secara periodik atau hasil uji laboratori...— post-license obligation
Authority by scale
PMA
2020 → 2025
Unchanged from KBLI 2020 — direct match.
Bali Intelligence
Complementary Codes
Common Questions
Can foreigners operate a electromedical & electrotherapy equipment business in Indonesia?
Yes. KBLI 26602 (Industri Peralatan Elektromedik dan Elektroterapi) is TERBUKA — open to 100% foreign ownership via PT PMA. No local Indonesian partner required.
What license is required for KBLI 26602?
KBLI 26602 has a Menengah Tinggi risk classification. Required license: NIB + Sertifikat Standar. Processing time: 7.
What is KBLI 26602?
KBLI 26602 is the Indonesian business classification code for "Industri Peralatan Elektromedik dan Elektroterapi" (Electromedical & Electrotherapy Equipment). It falls under Section C of KBLI 2025, the Indonesian Standard Industrial Classification updated by BPS (Regulation 7/2025). The June 2026 KBLI 2025 transition window has closed; operators should verify the code's current OSS/NIB treatment before relying on it for licensing, reporting, or amendments.
How did KBLI 26602 change from KBLI 2020 to 2025?
KBLI 26602 was mapped from previous code 26602 (KBLI 2020). This is a direct match — the code number and scope remained the same. The June 2026 KBLI 2025 transition window has closed. If an NIB still relies on legacy KBLI 2020 mappings, treat the migration as overdue and verify/remediate the OSS record before new license applications, amendments, LKPM, import approvals, or investor/worker sponsorship.
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🏢
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