Indonesia BPOM Regulatory News

Latest regulatory updates, standard revisions, and guidance publications in the medical device compliance space.

Regulatory Framework

Regulatory Authority: Ministry of Health (Kementerian Kesehatan), with BPOM oversight. Medical device regulation transferred from BPOM to Ministry of Health in recent reforms.

Key Legislation:

• Government Regulation No. 14/2023 on Medical Devices
• Minister of Health Regulation (Permenkes) on Medical Device Distribution
• ASEAN Medical Device Directive (AMDD) -- Indonesia is an AMDD signatory

Classification: Risk-based, 4 classes (aligned with ASEAN AMDD):

• Class A (low risk) | Class B (low-medium risk) | Class C (medium-high risk) | Class D (high risk)

Registration Pathway:

1. Obtain distribution license (Izin Edar) from Ministry of Health
2. Appoint a local authorized representative/distributor
3. Submit product dossier including CSDT (Common Submission Dossier Template per AMDD)
4. Class A: notification; Class B/C/D: full evaluation
5. Manufacturing site audit may be required

Key Requirements:

• Distribution License (Izin Edar) mandatory before marketing
• Local authorized representative/distributor required
• CSDT format documentation (ASEAN harmonized)
• Bahasa Indonesia labeling required
• ISO 13485 for manufacturing facilities
• SNI (Indonesian National Standard) compliance for certain categories

Current Key Guidance:

• Ministry of Health - Medical Devices
• ASEAN AMDD Framework & CSDT Guide
• ASEAN Standards & Conformance (Official)

Latest Updates

No recent updates available. Please check back later.