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Key Regulations

Primary Medical Device Regulation​

Permenkes No. 62 of 2017​

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

The cornerstone regulation for medical device registration in Indonesia. Establishes:

  • Requirement for NIE before any device can be distributed
  • Risk-based classification system (Class A–D)
  • Registration requirements and documentation
  • Local authorised representative obligations
  • One NIE, one holder rule (Article 13)
  • Post-market surveillance obligations

Halal Product Assurance​

Government Regulation (PP) No. 42 of 2024​

Regulation on Halal Product Assurance for Medical Devices

Introduces phased mandatory Halal labeling and certification:

  • Class A: October 2026
  • Class B: October 2029
  • Class C: October 2034
  • Class D / Biologicals: ~2039

Labeling​

Permenkes No. 11 of 2025​

Regulation on Medical Device Labeling

Formalises e-labeling provisions for professional-use devices. Confirms physical BI labels remain mandatory for high-risk and home-use devices. Establishes the "safety priority" rule for Bahasa Indonesia content.

Investment and Business Licensing​

Government Regulation No. 29 of 2021​

Regulation on the Implementation of Trade

Governs PT PMA and IDAK eligibility for foreign investment entities.

BKPM Regulation No. 4 of 2021​

Investment Coordination Board Regulation

Permits 100% foreign ownership under KBLI 46691 for medical device wholesale distribution, subject to IDR 10 billion minimum investment.

Personal Data Protection​

Law No. 27 of 2022 (UU PDP)​

Personal Data Protection Law

Governs processing of personal data including health data from connected medical devices. Came into force 2024.

Clinical Investigations​

BPOM Clinical Trial Regulations​

BPOM regulations governing clinical trial authorisation for medical devices and pharmaceuticals, including documentation requirements, ethics committee interaction, and GCP compliance.

ASEAN Reference Documents​

DocumentDescription
ASEAN Medical Device Directive (AMDD)Framework for harmonised ASEAN device regulation
ASEAN Common Submission Dossier Template (CSDT)Standard dossier format; latest version from ASEAN Secretariat
GHTF/SG1 Guidance DocumentsGlobal Harmonization Task Force guidance on essential principles, classification
IMDRF SaMD N10/N23/N41SaMD definition, QMS, and clinical evaluation guidance
Staying Current

Indonesian regulations are updated through Permenkes, Kepmenkes, and Surat Edaran (ministerial circulars). The Regalkes portal also publishes operational guidance updates. Always verify the current version of any regulation before relying on it for compliance decisions.