Class C — Moderate to High Risk Devices
Class C devices carry a moderate to high risk and require a full registration dossier with clinical evidence. Kemenkes evaluators may request local clinical evaluation data for certain Class C device types.
Examples of Class C Devices
- Ventilators and anaesthesia equipment
- Surgical lasers
- Haemodialysis machines
- Infusion pumps
- Powered surgical instruments
- Implantable devices (non-cardiac, short-term)
- Digital radiography systems
- Patient monitoring systems (multi-parameter)
- IVD analysers
Registration Pathway
Class C uses the full registration pathway via Regalkes, with enhanced documentation requirements:
- Complete ASEAN CSDT dossier
- Full clinical evaluation report required (not merely a literature summary)
- Kemenkes may request local clinical evaluations or local safety testing for certain Class C device categories
- ISO 13485 certification mandatory
- Review timeline: approximately 6–12 months
For certain Class C device categories, Kemenkes evaluators may request supplementary local clinical data or performance testing conducted in an Indonesian clinical setting. This requirement is assessed on a case-by-case basis and is more likely for novel technologies, devices without existing approvals in other ASEAN member states, or devices intended for populations with distinct demographic or clinical characteristics. Manufacturers should budget additional time and resources for this possibility during planning.
Documentation Requirements
All Class B documentation requirements apply, plus:
| Document | Class C Specific |
|---|---|
| Clinical Evaluation Report | Full systematic literature review + clinical evaluation |
| Local clinical data | May be required by MoH evaluator |
| Verification and validation data | Electrical safety, biocompatibility, sterility per applicable standards |
| Post-market surveillance plan | Required |
Halal Labeling Deadline
Class C devices must comply with Halal labeling requirements by 17 October 2034 under Government Regulation 42/2024.
Add the following sentence to the 'Review timeline' section:
Review timeline: approximately 6–12 months; timelines may be shorter for devices with existing approvals in other ASEAN member states.