CSDT Alignment
The CSDT as the Cross-ASEAN Standard
The ASEAN Common Submission Dossier Template (CSDT) is the standardised format for medical device registration dossiers across all ASEAN member states. Using the CSDT means that a dossier prepared for Singapore, Malaysia, Thailand, or the Philippines can serve as the foundation for an Indonesian submission with targeted modifications.
How Regalkes Maps to the CSDT
Indonesia's Regalkes submission format closely follows the CSDT module structure, with the following country-specific additions:
| CSDT Module | Regalkes Requirement | Indonesia-Specific Additions |
|---|---|---|
| Administrative | Required | Indonesian LAR details; IDAK/CDAKB numbers; device trade name as registered |
| Device Description | Required | No significant additions |
| Essential Principles | Required | Reference to Indonesian/ASEAN applicable standards |
| Testing and Performance | Required | Test reports from accredited laboratories |
| Pre-Clinical | Required | Consistent with CSDT; biocompatibility, sterility per applicable standards |
| Clinical Evidence | Required | Class-scaled; local data may be required for C/D |
| Risk Analysis | Required | ISO 14971; summary in Regalkes template format |
| Labeling | Required | Bahasa Indonesia content mandatory — key Indonesia-specific requirement |
| PMS Plan | Required for Class C/D | Indonesia-specific PMS contacts and adverse event reporting pathway |
| QMS | Required | ISO 13485 certificate with scope covering device |
Adapting a Singapore HSA CSDT for Indonesia
If you have already registered a device through Singapore's HSA using a CSDT, the following steps adapt the dossier for Indonesia:
- Administrative section: Replace HSA/Singapore LAR details with Indonesian LAR details; update IDAK/CDAKB numbers
- Labeling: Update all labels to include Bahasa Indonesia content; add NIE number (post-approval); verify Halal labeling status
- LoA: New LoA naming the Indonesian LAR; apostilled for Indonesia
- CFS: Current CFS apostilled for Indonesia
- ISO 13485 / GMP: Verify currency; apostille as required
- Regalkes formatting: Rename files per Regalkes naming conventions; restructure document organisation to match Regalkes template
Clinical evidence, risk management, technical specifications, and performance data can largely be reused from the HSA submission.
Adapting an EU MDR Technical Documentation for Indonesia
EU MDR Technical Documentation (TD) can be adapted for Indonesia but requires more restructuring than an ASEAN CSDT:
| Adaptation Task | Notes |
|---|---|
| Restructure into CSDT modules | EU MDR Annexes → CSDT module format |
| GSPR → Essential Principles checklist | Conceptually similar; reformatting required |
| Clinical evaluation report | Re-structure CER to fit CSDT clinical evidence module format |
| Labeling translation | Full Bahasa Indonesia translation of all safety content |
| Biocompatibility | ISO 10993 data acceptable |
| Standards | Map EU MDR referenced standards to equivalent ASEAN/Indonesian standards |