Glossary
A reference guide to the key Indonesian regulatory acronyms and terms used across this site.
A
AMDD — ASEAN Medical Device Directive. The regional harmonisation framework for medical device regulation across ASEAN member states. Indonesia is a signatory.
Apostille — A form of legalisation under the Hague Apostille Convention (1961) that authenticates documents for use in other signatory countries. Required for documents such as the LoA, CFS, and GMP certificate submitted to Kemenkes.
B
BPJPH — Badan Penyelenggara Jaminan Produk Halal (Halal Product Assurance Organising Agency). The Indonesian government body responsible for Halal product certification, including the phased Halal certification requirements for medical devices under GR 42/2024.
BPOM — Badan Pengawas Obat dan Makanan (National Agency of Drug and Food Control / NADFC). Regulates pharmaceuticals, cosmetics, traditional medicines, and food in Indonesia. Also conducts GMP inspections of device manufacturers and authorises clinical trials for devices.
C
CDAKB — Cara Distribusi Alat Kesehatan yang Baik (Good Distribution Practice for Medical Devices). Certificate issued by Kemenkes confirming that a distributor/LAR meets GDP standards. Mandatory alongside IDAK for NIE registration as of July 2024.
CFS / FSC — Certificate of Free Sale / Free Sale Certificate. Document confirming that a device is legally sold in the manufacturer's home country. Required as an administrative document in the CSDT dossier; must be apostilled/legalised.
CSDT — ASEAN Common Submission Dossier Template. The standardised dossier format used for medical device registration across ASEAN member states, including Indonesia.
D
Dirjen Kefarmasian dan Alat Kesehatan — The Directorate General of Pharmaceutical and Medical Devices within Kemenkes. The operational unit that manages device registrations, evaluations, and market surveillance.
F
FSCA — Field Safety Corrective Action. Any action taken by a manufacturer to reduce a risk of harm associated with a device already on the market (recall, modification, safety notice).
G
GCP — Good Clinical Practice. International standards for the design, conduct, recording, and reporting of clinical trials. Required for clinical investigations of medical devices in Indonesia.
GMP — Good Manufacturing Practice. Standards for manufacturing quality systems. GMP certificate required from the device manufacturer as part of the registration dossier.
I
IDAK — Izin Distribusi Alat Kesehatan (Medical Device Distribution Licence). Mandatory licence for any Indonesian company importing or distributing medical devices. Previously known as IPAK; valid for 5 years.
IFU — Instructions for Use. The document accompanying a medical device providing information for safe and effective use. Must be in Bahasa Indonesia (primary content) in Indonesia.
IPAK — Izin Penyalur Alat Kesehatan. The former name for the medical device distribution licence (now called IDAK).
J
JKN — Jaminan Kesehatan Nasional (National Health Insurance). Indonesia's universal health coverage programme, launched 2014. Drives significant demand for medical devices through public hospital procurement.
K
KBLI — Klasifikasi Baku Lapangan Usaha Indonesia (Indonesian Standard Business Field Classification). Business activity classification system used in OSS. KBLI 46691 is the code for wholesale medical device distribution, relevant to PT PMA and IDAK applications.
Kemenkes — Kementerian Kesehatan (Ministry of Health). The primary regulatory authority for medical devices in Indonesia. Issues NIEs, operates Regalkes, and conducts market surveillance.
Kepmenkes — Ministerial Decree of the Minister of Health. A specific type of regulatory instrument issued by the Minister of Health.
L
LAR — Local Authorized Representative. The Indonesian legal entity appointed by a foreign manufacturer to act as its representative for regulatory purposes, hold the IDAK, and own the NIE.
LoA — Letter of Authorization. The formal document appointing an Indonesian LAR. Must be notarised, apostilled/legalised, and valid for at least 5 years.
M
MDSAP — Medical Device Single Audit Program. A global QMS audit programme recognised by multiple regulatory authorities. Indonesia is not a formal MDSAP participant but may accept MDSAP certificates as supporting QMS evidence.
N
NADFC — National Agency of Drug and Food Control. The English-language name for BPOM.
NIB — Nomor Induk Berusaha (Business Identification Number). A unique identifier issued to every business registered through the OSS system. Required for IDAK application.
NIE — Nomor Izin Edar (Distribution Authorisation Number). The mandatory marketing authorisation issued by Kemenkes for medical devices. Must be printed on all packaging. Valid for 5 years.
O
OSS — Online Single Submission. The Indonesian government's integrated online business licensing platform (oss.go.id). Used to apply for IDAK and to obtain the NIB.
P
Permenkes — Peraturan Menteri Kesehatan (Minister of Health Regulation). The primary form of ministerial regulation governing healthcare and medical device matters.
PKRT — Perbekalan Kesehatan Rumah Tangga (Household Health Supplies). A product category regulated separately from medical devices, covering household disinfectants and similar products.
PNBP — Penerimaan Negara Bukan Pajak (Non-Tax Government Revenue). The government fee system for NIE registration and other regulatory applications. Fees are paid via Regalkes billing after passing administrative review.
PP — Peraturan Pemerintah (Government Regulation). Higher-order regulations issued by the President of Indonesia. GR 42/2024 (Halal labeling) is an example.
PT PMA — Perusahaan Terbatas Penanaman Modal Asing (Foreign Investment Limited Company). A foreign-owned Indonesian subsidiary through which manufacturers can hold their own IDAK and NIE.
R
Regalkes — Indonesia's Ministry of Health online portal for medical device registration, renewal, and post-market submissions. Accessed at regalkes.kemkes.go.id.
S
SaMD — Software as a Medical Device. Software intended to perform medical purposes independently of hardware. Regulated under Indonesia's general device framework; dedicated SaMD guidance is under development.
SDAK — Sertifikat Distribusi Alat Kesehatan. An older form of distribution certificate with no fixed validity (unlike the time-limited IDAK).
SKI — Surat Keterangan Impor (Import Certificate). A per-shipment import permit required for each shipment of medical devices (including investigational devices) imported into Indonesia.
U
UU PDP — Undang-Undang Perlindungan Data Pribadi (Personal Data Protection Law, Law No. 27 of 2022). Governs personal data processing in Indonesia, relevant to connected devices and digital health platforms processing Indonesian patient data.