ASEAN Common Submission Dossier Template (CSDT)
What Is the CSDT?
The ASEAN Common Submission Dossier Template (CSDT) is the standardised dossier format used for medical device registration across ASEAN member states, including Indonesia. It was developed under the ASEAN Medical Device Directive (AMDD) harmonisation initiative to enable more efficient multi-market submissions across Southeast Asia.
Indonesia's Regalkes submissions closely follow the CSDT structure, though Kemenkes applies Indonesian-specific formatting requirements and file naming conventions on top of the CSDT framework.
CSDT Module Structure
The ASEAN CSDT is organised into modules:
| Module | Content |
|---|---|
| Administrative Information | Device name, trade name, manufacturer details, LAR details, classification, intended use |
| Device Description and Specification | Physical description, dimensions, materials, accessories, variants |
| Essential Principles Checklist | Confirmation of compliance with each applicable essential principle |
| Design Type Testing | Test reports demonstrating conformance with applicable standards |
| Pre-Clinical Studies | Biocompatibility, sterility, electrical safety, shelf-life, stability |
| Clinical Evidence | Clinical evaluation report, clinical investigation data (if applicable) |
| Risk Analysis | ISO 14971-based risk management file summary |
| Labeling | Final approved labels and IFU in Bahasa Indonesia (and English) |
| Post-Market Surveillance Plan | Planned PMS activities post-approval |
| QMS Information | ISO 13485 certificate, QMS scope |
CSDT vs EU MDR Technical Documentation
Manufacturers with existing EU MDR Technical Documentation (TD) will find significant overlap but important structural differences:
| Element | EU MDR TD | ASEAN CSDT |
|---|---|---|
| Structure | Annexes I–XVII | CSDT modules (above) |
| Essential requirements | EU MDR Annex I | ASEAN Essential Principles |
| Clinical evaluation | CER per MEDDEV 2.7/1 rev 4 | Clinical evidence module |
| GSPR | EU MDR Annex II | Essential principles checklist |
| Risk management | ISO 14971 | ISO 14971 (same) |
| Labeling language | EU languages | Bahasa Indonesia mandatory |
The content is largely compatible — the primary work is restructuring and reformatting your existing documentation to fit the CSDT modules and Regalkes upload requirements.
CSDT vs FDA Submission Formats
FDA 510(k) and PMA formats are significantly different from the CSDT. Key adaptations needed:
- Restructure the 510(k) summary/predicate comparison into CSDT modules
- Convert FDA-format risk analysis to ISO 14971 format (if not already done)
- Translate/adapt labeling to Bahasa Indonesia
- Add the Essential Principles checklist
- Reorganise clinical evidence per CSDT clinical evidence module
Adapting an Existing ASEAN CSDT
Adapting an Existing ASEAN CSDT: If you have already registered the device in Singapore (HSA) or Malaysia (MDA) using a CSDT, adaptation for Indonesia is the most straightforward:
• Reuse the CSDT content (technical modules remain largely consistent) • Update the administrative section for the Indonesian LAR (new Letter of Authorization) • Revise labeling to ensure full Bahasa Indonesia compliance (will add NIE number after approval) • Confirm the ISO 13485 certificate scope covers the same manufacturing activities • Verify that any clinical evidence or risk management file remains current and applicable to the Indonesian market • Update the Site Master File if manufacturing has changed since the prior ASEAN submission
This is one of the strongest arguments for sequencing market entry in the ASEAN region — prior ASEAN approvals significantly reduce the work and timeline for Indonesian registration.
This is one of the strongest arguments for sequencing market entry in the ASEAN region — prior ASEAN approvals significantly reduce the work for Indonesian registration.
Indonesia
Indonesian-Specific Requirements
Beyond the standard CSDT structure, Regalkes submissions must adhere to:
• File naming conventions: typically 'CSDT_[Module][DeviceName][Version]' in PDF format • All technical documents must be combined into a single PDF per module or as directed by Regalkes portal guidelines • Verification through the Regalkes portal system to ensure correct module assignment before final submission
Refer to the Regalkes Portal section for detailed submission formatting requirements.