Kemenkes
Indonesia — Kemenkes
Permenkes No. 62/2017 + Kemenkes digital-health regulations
Authority
Ministry of Health (Kemenkes); BPOM for combination products
Enforced
2017
Legal framework
Permenkes 62/2017 + UU PDP (Personal Data Protection Law 2022) + BSSN guidance
Scope
All medical devices distributed in Indonesia, including SaMD. Risk-class based registration.
Pre-market
Risk-class registration dossier, halal certification where applicable, e-Watch reporting commitments.
Post-market
e-Watch adverse event reporting, distribution audits.
SBOM
RecommendedEncouraged in line with IMDRF N60; mandate expected as digital-health rules mature.
Vulnerability disclosure
BSSN (National Cyber and Crypto Agency) coordinated disclosure recommended.
Penalty
Registration revocation; UU PDP fines up to 2% of annual revenue.
Unique requirements
- 01Indonesian Distributor Holder (IPAK)
- 02Bahasa Indonesia labelling
- 03Halal certification for relevant categories
Highlights
- UU PDP closely modelled on GDPR
- BSSN cybersecurity overlay for hospitals
- Largest ASEAN device market by population
Aligns with
Timeline
-
2017
Permenkes 62/2017 issued
-
Oct 2022
UU PDP enacted
-
Oct 2024
UU PDP full enforcement
Key documents
Related markets
Frequently asked about Indonesia
Is SBOM required for medical devices in Indonesia?
Recommended. Encouraged in line with IMDRF N60; mandate expected as digital-health rules mature.
What does Kemenkes require for pre-market cybersecurity?
Risk-class registration dossier, halal certification where applicable, e-Watch reporting commitments.
What are the post-market cybersecurity obligations under Kemenkes?
e-Watch adverse event reporting, distribution audits.
What is the penalty for non-compliance with Kemenkes cybersecurity rules?
Registration revocation; UU PDP fines up to 2% of annual revenue.
How much of my FDA cybersecurity package is reusable in Indonesia?
Roughly 65% — an editorial estimate based on overlapping evidence requirements (threat model, SBOM, security risk assessment, pen-test report).