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ASEAN Common Submission Dossier Template (CSDT)

What is the CSDT?​

The ASEAN Common Submission Dossier Template (CSDT) is a standardised format for medical device registration dossiers developed by the ASEAN Medical Device Committee. It is designed to allow manufacturers to prepare a single core submission package that can be used across multiple ASEAN markets, reducing the duplication of effort involved in preparing country-specific dossiers.

The CSDT defines:

  • The structure and content of the registration dossier;
  • The sections required for different device classes and types;
  • Common terminology and formatting standards.

CSDT and Singapore's SHARE submissions​

Singapore's registration dossier requirements for the SHARE portal are broadly aligned with the CSDT structure. Manufacturers preparing an ASEAN-wide regulatory strategy can use CSDT-structured technical documentation as the basis for both Singapore submissions and submissions to other ASEAN national authorities.

Where to find the CSDT​

The current version of the ASEAN CSDT is published on the ASEAN Sectoral Working Group on Medical Devices website. HSA also references CSDT guidance in its own guidance documents.

Strategic use of the CSDT​

For manufacturers entering multiple ASEAN markets:

  1. Prepare a core CSDT-structured dossier;
  2. Submit to Singapore first (or in parallel) to leverage the Abridged/Expedited routes;
  3. Use the Singapore registration and Free Sale Certificate to support submissions in other ASEAN countries;
  4. Adapt the core dossier to meet any country-specific requirements (e.g. local language translations, country-specific labelling requirements).

Official sources​