KBLI 32509★ Gold-Tier Intel
Other Medical & Dental Equipment Manufacturing
Industri Peralatan Kedokteran dan Kedokteran Gigi, serta Perlengkapan Lainnya
🏭 Section C — Manufacturing
In Bali: open to a PT PMA
✅Open· 100% ForeignHigh RiskDirect MatchRegistrable in Bali· medium conf.
Manufacturing medical and dental supplies - this covers producing specialized protective gear and surgical materials not classified elsewhere. Activities include making surgical masks (FFP2/FFP3), surgical drapes, gowns, and wound dressings. It also covers producing dental wax, plaster preparations, and bone reconstruction cement.
Licensing & Requirements
What You Need
Risk LevelHigh (Tinggi)
License TypeNIB + Izin
Processing7 working days
Foreign Ownership100% Open
AuthorityBKPM / OSS
PP28/2025 Licensing Data4 scales
Business scale:
MikroHigh RiskNIB + Izin⏱ 7Fiktif Positif
Requirements (Indonesian)6
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 perjanjian kerja yang membuktikan kepemilikan karyawan yang bekerja sebagai Penanggung Jawab Teknis (PJT) alat kesehatan yang bekerja penuh waktu dengan rincian sebagai berikut:
5Memiliki paling sedikit 3 (tiga) orang dengan kualifikasi yang sesuai masing masing sebagai: a) Penanggung jawab produksi b) Penanggung jawab pemastian mutu dan c) Penanggung jawab pengawasan mutu
6Memiliki 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 + Business License (Izin) (Small, High risk)— Authority: Bupati/Walikota — 7 Hari
4
NIB + Business License (Izin) (Medium, High risk)— Authority: Bupati/Walikota — 7 Hari
5
NIB + Business License (Izin) (Large, High risk)— Authority: Gubernur Menteri/ Kepala Badan — 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
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Read Full Guide on Bali Zero↗
KBLI 2025 Manufacturing & Production: Industrial Business Codes
kita.balizero.comComplementary Codes
Common Questions
Can foreigners operate a other medical & dental equipment manufacturing business in Indonesia?
Yes. KBLI 32509 (Industri Peralatan Kedokteran dan Kedokteran Gigi, serta Perlengkapan Lainnya) is TERBUKA — open to 100% foreign ownership via PT PMA. No local Indonesian partner required.
What license is required for KBLI 32509?
KBLI 32509 has a Tinggi risk classification. Required license: NIB + Izin. Processing time: 7.
What is KBLI 32509?
KBLI 32509 is the Indonesian business classification code for "Industri Peralatan Kedokteran dan Kedokteran Gigi, serta Perlengkapan Lainnya" (Other Medical & Dental Equipment Manufacturing). 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 32509 change from KBLI 2020 to 2025?
KBLI 32509 was mapped from previous code 32509 (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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