Class D — High Risk Devices
Class D represents the highest risk category in Indonesia's classification system. These are typically active implantables, life-sustaining devices, or devices with significant potential consequences from failure. They face the most intensive regulatory scrutiny.
Examples of Class D Devices
- Active implantable cardiac devices (pacemakers, implantable cardioverter-defibrillators)
- Cardiac stents (drug-eluting and bare metal)
- Cochlear implants
- Deep brain stimulators
- Spinal cord stimulators
- Total artificial hearts
- Devices for extracorporeal circulation
- Long-term implantable devices in direct contact with blood or central nervous system
Registration Pathway
Class D requires a comprehensive registration dossier with the highest level of clinical and technical documentation:
- Complete ASEAN CSDT dossier
- Full clinical data including clinical investigation reports where literature alone is insufficient
- Comprehensive risk management file (ISO 14971)
- Detailed traceability and recall plan (mandatory)
- Post-market surveillance plan
- Periodic Safety Update Reports (PSUR) commitment
- ISO 13485 mandatory
- Review timeline: 6–12 months minimum; complex devices may exceed with extensive clinical data or those requiring deficiency letter cycles this. Applicants should plan for potential review cycles and queries from Kemenkes evaluators.
Documentation Requirements
| Document | Class D Specific |
|---|---|
| Clinical Evaluation Report | Full, peer-reviewed clinical data; clinical investigation data where required |
| Risk Management File | Comprehensive per ISO 14971; residual risk justification mandatory |
| Traceability System | Mandatory — must be able to identify and locate all distributed units |
| Recall Plan | Formal documented plan required |
| PSUR commitment | Periodic safety reporting as directed by Kemenkes |
| Post-Market Surveillance Plan | Full PMS plan required at time of submission |
Post-Approval Obligations
Class D manufacturers face the most stringent ongoing obligations:
- Prompt adverse event reporting to Kemenkes (serious incidents — report as soon as possible, typically within 30 days or sooner for death/serious injury)
- Periodic safety update reports
- Field safety corrective action (FSCA) protocols must be established prior to launch
- Regular CDAKB inspections of the LAR are more frequent for Class D product holders
Halal Labeling Deadline
Class D devices (and biological products) have a Halal labeling compliance deadline of approximately 2039 under Government Regulation 42/2024, reflecting the complexity of material sourcing for these device categories.
The ASEAN CSDT (Common Submission Dossier Template) must include all required modules: administrative data, device description and specifications, nonclinical laboratory study data, clinical data, clinical evaluation report, risk management file (ISO 14971), and production information. Digital submission via the Regalkes system is required.
Manufacturers should designate a qualified Regulatory Affairs representative to serve as the primary contact with Kemenkes during the review period. Two-way communication with evaluators, including responses to queries (deficiency letters), is expected within specified timeframes (typically 30 days for each query cycle).