KBLI 21022★ Gold-Tier Intel
Herbal Medicine Product Manufacturing, Human
Industri Produk Obat Bahan Alam untuk Manusia
🏭 Section C — Manufacturing
In Bali: open to a PT PMA
✅Open· 100% ForeignHigh RiskDirect MatchRegistrable in Bali· medium conf.OSS-verified · KBLI 2025
Natural-Medicine Manufacturing for a Fully Open PMA Setup
KBLI 21022 covers human natural-medicine product manufacturing, open nationally to full foreign ownership and not blocked for PMA registration in Bali under the record.
Based only on this record, KBLI 21022 is nationally foreign-open up to 100% and is not blocked for PMA registration in Bali by the moratorium logic stated here.
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)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 c. Perjanjian jual beli/sewa yang membukti-kan: 1) Penguasaan (kepemilikan/ sewa) mesin untuk menghasilkan produk farmasi 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 bangunan, Fasilitas, dan peralatan, dibuktikan dengan dokumen denah/layout Fasilitas produksi yang berisi rincian daftar ruangan/area, fungsi, dan foto
5Memiliki program higiene dan sanitasi yang dibuktikan dengan dokumen standar operasional prosedur paling sedikit memuat tentang a. Higiene perorangan b. Sanitasi bangunan & Fasilitas c. Sanitasi peralatan
6Memiliki dokumen standar operasional prosedur untuk menyusun standar operasional prosedur
7Memiliki dokumen surat pernyataan kepemilikan Apoteker Penanggung Jawab (APJ) dengan kualifikasi Apoteker atau Tenaga Teknis Kefarmasian yang bekerja penuh waktu paling sedikit 1 (satu) orang
Post-License Obligations9
Memiliki dokumen Surat Keterangan Penanggung Jawab Teknis Usaha Kecil Obat Bahan Alam
Memiliki dokumen Surat Keterangan Penanggung Jawab Teknis Usaha Mikro Obat Bahan Alam
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 layanan keluhan pelanggan/ produk terhadap: a. Kejadian tidak diinginkan (adverse event) b. Kualitas produk (product quality) yang membuktikan komitmen pelayanan minimal kepada pelanggan
Memiliki dokumen hasil kalibrasi peralatan quality control secara periodik atau hasil uji laboratorium independen atas produk yang dihasilkan secara periodik
Memiliki SOP keamanan dan keselamatan atas: a. Penyimpanan bahan baku berupa bahan kimia b. Penggunaan mesin/ peralatan c. Proses produksi
Penggunaan bahan baku memperhatikan Farmakope Herbal Indonesia atau standar lain yang ditentukan
Menyampaikan laporan penyaluran produk setiap 6 (enam) bulan sesuai ketentuan perundang undangan di bidang 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 — 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 layanan keluhan pelanggan/ produk terhadap: a. Kejadian tidak diinginkan (adverse event) b....— post-license obligation
Authority by scale
PMA
2020 → 2025
Unchanged from KBLI 2020 — direct match.
Bali Intelligence
Complementary Codes
Sources & Verification
Each data layer below traces to a government source with its KBLI vintage — or is declared as a gap. Nothing in these layers is silently filled in.
Activity definition
BPS Peraturan 7/2025 + PP 28/2025VerifiedKBLI 2025
Title and scope as defined by the KBLI-2025 classification.
locator: OSS_RBA_2025_id_version_fff4053d
Risk & licensing
OSS RBA risk scope (ruang lingkup)VerifiedKBLI 2025
Risk category and licensing rows are KBLI-2025-native from the OSS Risk-Based Approach catalog.
locator: OSS_RBA_resiko_2025
Foreign ownership (PMA)
Perpres 10/2021, 49/2021Audit pendingKBLI 2020
The investment-list annexes predate KBLI 2025; the per-code crosswalk audit of this layer is in progress. The value shown is the annex text, disclosed with its vintage.
Bali status
Bali province blocks ALL Low + Medium-Low risk KBLI for PMA (island-wide, permanent) (effective 2026-05-13)Audit pending2026 overlay
Conservative posture derived from the risk tier · confidence MEDIUM.
Dataset last updated 2026-07-26 · KBLI 2020 and KBLI 2025 reuse code numbers for different activities — cross-vintage rows are labeled, never merged silently.
Common Questions
Can foreigners operate a herbal medicine product manufacturing, human business in Indonesia?
Yes. KBLI 21022 (Industri Produk Obat Bahan Alam untuk Manusia) is TERBUKA — open to 100% foreign ownership via PT PMA. No local Indonesian partner required. (Source: Perpres 10/2021 as amended by Perpres 49/2021 — the investment-list annexes predate KBLI 2025; per-code crosswalk audit in progress.)
What license is required for KBLI 21022?
KBLI 21022 has a Tinggi risk classification. Required license: NIB + Izin. Processing time: 7.
What is KBLI 21022?
KBLI 21022 is the Indonesian business classification code for "Industri Produk Obat Bahan Alam untuk Manusia" (Herbal Medicine Product Manufacturing, Human). 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 21022 change from KBLI 2020 to 2025?
KBLI 21022 was mapped from previous code 21022 (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.
Related Codes
21023Section C
Herbal Medicine Product Manufacturing, Veterinary
Industri Produk Obat Bahan Alam untuk Hewan
Blocked in Bali (risk-class moratorium)✅Open· 100% nat'l · blocked in BaliMedium-Low Risk
21021Section C
Herbal Medicine Raw Material Manufacturing, Human
Industri Bahan Baku Obat Bahan Alam untuk Manusia
Registrable in Bali✅Open· 100% ForeignHigh Risk
21024Section C
Herbal Medicine Raw Material Manufacturing, Veterinary
Industri Bahan Baku Obat Bahan Alam untuk Hewan
Registrable in Bali✅Open· 100% ForeignHigh Risk
21015Section C
Medical Diagnostics, Bandages & Health Support Devices
Industri Alat Diagnosis Medis, Perban, Kasa, dan Penunjang Kesehatan Lainnya
Registrable in Bali✅Open· 100% ForeignHigh Risk
21014Section C
Veterinary Pharmaceutical Raw Material Manufacturing
Industri Bahan Baku Farmasi untuk Hewan
Registrable in Bali✅Open· 100% ForeignMedium-High Risk
21013Section C
Veterinary Pharmaceutical Product Manufacturing
Industri Produk Farmasi untuk Hewan
Blocked in Bali (risk-class moratorium)✅Open· 100% nat'l · blocked in BaliMedium-Low Risk
🏢
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