To harmonize ASEAN filings and reduce redundant work, the ASEAN Medical Device Directive introduced the Common Submission Dossier Template (CSDT). Indonesia’s Ministry of Health now accepts and prefers the CSDT layout, making it your fastest route to dossier acceptance in the medical device registration process.
By aligning with the CSDT, you speak the same regulatory “language” as other ASEAN markets—ensuring fewer back-and-forths, clearer reviewer expectations, and ultimately, a speedier NIE issuance.
Insider Tip: If you’re a foreign manufacturer, remember that only a local Indonesian entity can hold the NIE license. Appoint an authorized local representative early and prepare a notarized Letter of Authorization to include in your dossier. Using the CSDT format also lets you reuse documentation from other ASEAN markets (like Singapore or Malaysia) with minimal tweaks, accelerating multi-country approvals
What Is the ASEAN CSDT?
The CSDT is a structured dossier framework covering all key sections, and when properly assembled, it becomes your “cheat sheet” to avoid rework.
How Does It Work for the Medical Device Registration Process in Indonesia?
Indonesia’s Regalkes Licensing Guidelines explicitly reference the CSDT as the preferred format, provided you supplement it with any Indonesia-specific items, such as local labeling requirements or Bahasa translations (Regalkes Kemenkes PDF).
Here’s how to use the CSDT effectively:
- Administrative Data
- Complete the MoH cover letter template (download from Regalkes site).
- Use the CSDT application form without modifying the field order.
- Letter of Authorization: Foreign manufacturers should provide a notarized Letter of Authorization for their Indonesian license holder, as required by MoH
- Medical Device Description & Classification
- State the device’s ASEAN risk class (A–D) per AMDD.
- Include both global and local model numbers.
- Technical Documentation
- Link your Design Dossier to each claim in the IFU.
- Provide a risk management report (ISO 14971) with an “Indonesia addendum.”
- Quality Management System
- Attach your ISO 13485 certificate (mandatory for foreign manufacturers) and recent audit reports..
- If you lack ISO 13485, provide equivalent evidence of QMS (e.g. an official GMP certificate plus CAPA records), but be aware this may not be acceptable for higher-risk devices..
- Performance & Safety Data
- Collate bench and biocompatibility tests under one annex.
- Translate key safety statements into Bahasa Indonesia.
- Labeling & IFU
- Regulatory Check: Ensure your product labels meet all current MoH requirements. This includes any new rules such as Halal markings (if applicable to your device’s materials) and the distributor’s information on the label. Missing these details can lead to last-minute corrections or rejections during evaluation..
- Ensure IFU includes local language instructions and disposal info.
Integrating the cheat-sheet checklist directly into the CSDT overview streamlines the process, creating a single, continuous workflow that eliminates the need to switch between sections.
Insider Tip: Always perform a thorough final review of your dossier. Ensure every document is up-to-date (no expired certificates or outdated test reports) and that all content is consistent and specific to your product. We often see delays when submissions contain expired ISO certificates or copy-pasted text referencing the wrong product/country – mistakes that a pre-submission audit would catch. By embedding a QA checklist into your CSDT, you can spot these issues early and fix them before they derail your application
Fast-Track Timeline & Best Practices
Even with a flawless dossier, knowing the right sequence can shave weeks off your approval.
Starting your dossier early in CSDT format allows you to parallelize translation, technical review, and system upload. Think of it as running multiple lanes on a track, not one baton pass at a time.
Typical Fast-Track Timeline
- Week 0: Verify your local representative has all required Indonesian licenses (a valid IDAK/IPAK distribution license and a Good Distribution Practice (CDAKB) certificate)
- Weeks 1–2: Gather global test reports and begin Bahasa translations simultaneously.
- Week 3: Assemble CSDT sections, cross-check against Indonesian checklists, and upload drafts to OSS for pre-screening.
- Week 4: Submit your NIE application; respond to any minor reviewer queries within days.
Insider Tip: Applications get rejected if the local agent’s license is missing or expired, especially CDAKB
Best Practices from Regional Benchmarks
- Pre-Submission Audit: In Singapore, manufacturers conduct an internal “mock review” to catch gaps early. Do the same for Indonesia – verify that your dossier is compiled in the exact CSDT order and that all required sections are present. Check for any inconsistencies or missing pieces (e.g. untranslated text, outdated test data) before submission
- Parallel Translations: Malaysian exporters translate dossiers into Malay alongside English drafting—apply the same to Bahasa.
- Dedicated Coordinator: Thailand’s top firms assign a single specialist to manage version control, preventing conflicting updates.
By adopting these approaches, you minimize reviewer questions, avoid late-stage corrections, and reach NIE approval in weeks rather than months.
Indonesia’s regulatory landscape moves fast, and the CSDT is your cheat code to staying ahead. Structuring your dossier around the CSDT not only harmonizes with ASEAN peers but also dramatically reduces review cycles and back-and-forths.
By partnering with ProductRegistrationIndonesia.com, we can help you use the latest CSDT guidelines plus Indonesia-specific addenda, including providing documents in Bahasa Indonesia, to avoid misinterpretation and OSS portal support by our expert team.
Staying vigilant about document quality – from valid certificates to accurate translations – is just as critical as following the CSDT format. With the right preparation and expert guidance, you’ll avoid common pitfalls and achieve approval faster.
