Skip to main content

Key Legislation

Indonesia's medical device regulatory framework is built on a layered hierarchy of laws, government regulations (Peraturan Pemerintah, PP), and ministerial regulations (Peraturan Menteri Kesehatan, Permenkes).

Primary Regulation​

Permenkes No. 62 of 2017​

Minister of Health Regulation on Marketing Authorisation of Medical Devices, IVDs, and Household Health Products

This is the cornerstone regulation. It establishes:

  • The requirement for all medical devices to hold a valid NIE (Nomor Izin Edar) before distribution
  • The four-class (A–D) risk-based classification system
  • Registration requirements by risk class
  • Local authorised representative (LAR) obligations
  • The one-NIE-one-holder rule (Article 13)
  • Post-market obligations including adverse event reporting
info

As of 2025, Permenkes 62/2017 remains the primary operative regulation for medical device registration. Always check for amendments or supplementary ministerial circulars (Surat Edaran) that may update specific requirements.

Distribution and Good Distribution Practice​

CDAKB Regulations​

Cara Distribusi Alat Kesehatan yang Baik (CDAKB) — Good Distribution Practice for Medical Devices

  • Sets requirements for QMS, storage conditions, traceability, complaint handling, and recall procedures at the distributor level
  • From July 2024, CDAKB certification is mandatory before any new NIE application can be submitted
  • Enforced through periodic Kemenkes inspections; suspension or revocation of CDAKB results in automatic freezing of all associated NIEs

Halal Product Assurance​

Government Regulation (PP) No. 42 of 2024​

Regulation on Halal Product Assurance for Medical Devices

Introduces a phased mandatory Halal labeling compliance timeline:

Device ClassCompliance Deadline
Class A (Low Risk)17 October 2026
Class B (Moderate Risk)17 October 2029
Class C (Moderate-High Risk)17 October 2034
Class D (High Risk) and Biological Products~2039 (TBC)
  • Products containing non-halal materials (e.g. porcine-derived components) must display specific non-halal icons/text — they are not prohibited but must be transparently labeled
  • Manufacturers should begin assessing their supply chain and material provenance now to meet these deadlines

Labeling​

Permenkes No. 11 of 2025​

Regulation on Medical Device Labeling

  • Formalises e-labeling (electronic Instructions for Use) for professional-use devices in clinical settings
  • Confirms that physical printed labels in Bahasa Indonesia remain mandatory for high-risk and home-use devices
  • Establishes the "safety priority" rule: all warnings, contraindications, and primary usage instructions must be available in Bahasa Indonesia regardless of e-labeling use

Investment and Business Licensing​

Government Regulation No. 29 of 2021​

Regulation on the Implementation of Trade

Governs PT PMA (foreign-owned company) restrictions in wholesale trade, relevant to manufacturers establishing their own IDAK-holding entity in Indonesia.

BKPM Regulation No. 4 of 2021​

Allows foreign-owned companies to hold an IDAK under KBLI 46691 (Wholesale Trade of Laboratory Equipment, Pharmaceutical Devices, and Medical Devices), subject to minimum investment requirements (IDR 10 billion, excluding land and buildings).

Clinical Investigations​

BPOM Regulations on Clinical Trials for Medical Devices​

Clinical investigations for unregistered devices require:

  • Prior approval from BPOM
  • Ethical clearance from an accredited ethics committee
  • Compliance with Good Clinical Practice (GCP) guidelines

Key ASEAN Reference Documents​

DocumentDescription
ASEAN Medical Device Directive (AMDD)Framework for harmonised device regulation across ASEAN member states
ASEAN Common Submission Dossier Template (CSDT)Standard dossier format used for registration submissions
GHTF Study Group 1 Guidance DocumentsGlobal Harmonization Task Force guidance on essential principles, classification, and QMS

Staying Up to Date​

Indonesian regulations can be updated through:

  • Permenkes — full ministerial regulations (published in the State Gazette)
  • Kepmenkes — ministerial decrees on specific matters
  • Surat Edaran — ministerial circulars providing guidance or operational updates
  • Regalkes portal announcements — maintenance windows, system changes, submission procedure updates
tip

Subscribe to official Kemenkes and BPOM announcement channels, and monitor the Regalkes portal for system updates. Regulatory changes are not always widely publicised in English.