What is the Common Submission Dossier Template (CSDT) and How to Use it

Harmonizing Application Requirements in Southeast Asia

Manufacturers looking to Southeast Asia to help grow their medical device sales should become familiar with the Common Submission Dossier Template, or “CSDT.” The CSDT is the application standard developed under the ASEAN Medical Devices Directive (ASEAN MDD), meant to help harmonize the regulatory requirements in the region. By harmonizing the documentation, ASEAN member countries reduce the burden to entry for foreign manufacturers by limiting the alterations needed prior to application submission. CSDT is similar to the documentation submitted for a US 510(k) and CE Marking in Europe and will require chapters such as an executive summary, the essential principles to show conformity, device description, design verification, clinical data (CER), labeling, risk analysis, and manufacturer information.

The History of the ASEAN MDD and CSDT

The CSDT, or the Common Submission Dossier Template, was developed as part of the ASEAN MDD and has been implemented in member countries according to their own schedules. Singapore’s Health Science Authority (HSA) is seen as the gold standard in the region is often the “ASEAN Reference country” as they are typically first to implement, provide very clear guidance and regulations, and their approvals can sometimes be leveraged in other ASEAN markets for quick review times. Their CSDT guidance for non-IVDs can be found here (PDF) and IVD guidance can be found here (PDF).

Originally established as the Association of Southeast Asia (ASA) in 1961, the Association of Southeast Asian Nations (ASEAN) includes 10 countries and promotes intergovernmental cooperation and facilitates economic, political, security, military, educational, and sociocultural integration between its members and other countries in Asia. Member countries include Singapore, Malaysia, Thailand, Vietnam, Indonesia, the Philippines, Brunei, Cambodia, Myanmar, and Laos. At the time of publishing the Secretary General is Lim Jock Hoi as Brunei holds the chair for 2022. In 2008, ASEAN member countries met and agreed to move closer to “an EU-style community” but the relationship has not been established as intended with many countries remaining autonomous, implementing ASEAN policies at their own pace.

Implementation of CSDT Among ASEAN Member Countries

At this time, CSDT documentation is accepted in Singapore, Malaysia, Indonesia, the Philippines, Thailand, and will start being accepted in Vietnam in 2023 for Class C and D devices. It is also expected that competent authorities may establish new expedited reviews for products already approved with CSDT documentation in other ASEAN Member States. For example, the Philippines FDA has established an expedited review for applications submitted with the same documentation used for an approval in a member market. Thailand has also created a similar process but is only available for high-risk devices at this time though it is expected to expand to lower risk products in the future.

Below is a quick synopsis of how CSDT is used in each country and more information on the registration process in each country can be found by clicking on each country’s name:

1. Singapore: CSDT format is required.
2. Malaysia: CSDT format is required.
3. Philippines: CSDT format is required. The PFDA will expedite review of CSDT documents approved by any other ASEAN member country that reviewed the exact same documentation i.e. Singapore, Malaysia, Thailand, Indonesia.
4. Thailand: CSDT format is required. The TFDA will expedite the review of applications for products approved by Singapore’s HSA that used the exact same documentation.
5. Indonesia: CSDT format is required.
6. Vietnam: CSDT format is not currently required but the MOH is expected to implement CSDT format for Class C and D applications in 2023 or 2024.