Medical Device Registration in
Indonesia
Ministry of Health
Regulatory Authority
Medical Device Regulation
ASEAN Medical Devices Directive
Official Language
Indonesian
Classification
Class A,B,C,D
Registration Process
- Determine the device classification
- Appoint an Authorized Representative.
- The marketing authorization can be carried out in the following ways:
Part 1: Premarket Control
- Manufacturer License (ISO 13485 for QMS)
- Distribution License (Good Distribution Practise)
- Registration License (ASEAN CDST)
Part 2: Post market Control
The ASEAN AMDD guideline is used for post-market control and includes
- Sampling
- Monitoring
- Vigilance
- Advertisement
Documents Required
- Executive Summary
- Device Labelling
- Detailed Manufacturer Information
- Essential Principles of Safety and Performance of Medical Device
- Summary of Design verification and validation documents
- Risk Analysis
- Quality Management Certification
- Declaration of Conformity
- Letter of Confirmation for market history proof from the manufacturer
- Letter of Safety confirmation from the manufacturer
- Other Regulatory Authority approvals
- Letter of Authorization
Applicable QMS
ISO 13485:2016
Registration Timeline
- Class A- 15 days
- Class B, C -30 days
- Class D- 45 days
Authorized Representative
Yes
License Validity
5 years