At EPINTEK, we specialize in helping medical device and IVD manufacturers navigate the regulatory landscape of the Southeast Asian market. As the region continues to harmonize its regulatory requirements under the ASEAN Medical Device Directive (AMDD), one of the key tools for streamlined market access is the Common Submission Dossier Template (CSDT) — a standardized format recommended in Annex 4 of the AMDD for pre-market submissions.

The ASEAN CSDT is recognized by all ten ASEAN member states: the Philippines, Malaysia, Singapore, Thailand, Brunei, Vietnam, Myanmar, Laos, Cambodia, and East Timor. It serves as a unified technical documentation template for manufacturers seeking registration in multiple countries within the region. Based on the IMDRF Summary Technical Documentation (STED) framework, the CSDT aims to simplify and standardize the submission process, reducing redundant efforts and accelerating approval timelines for companies entering the ASEAN market.

Why Choose EPINTEK for ASEAN CSDT Registration?

ü Expertise in ASEAN CSDT Preparation:
We help you prepare your technical documentation in full compliance with the ASEAN CSDT format, ensuring consistency and clarity across all required sections.

ü Comprehensive Regulatory Support:
From drafting and organizing the dossier to coordinating local submissions, we provide full-service support tailored to each country’s specific requirements — including language adaptations if needed.

ü Alignment with IMDRF Standards:
Our approach ensures that your CSDT aligns with international best practices, facilitating not only regional but also global regulatory strategies.

ü Support for Both General Medical Devices and IVDs:
Whether your product is a general medical device or an in vitro diagnostic (IVD), we offer customized solutions that meet the structure and content expectations of ASEAN regulatory authorities.

With our deep understanding of both the technical and regulatory aspects of the ASEAN CSDT process, EPINTEK empowers manufacturers to efficiently enter and expand within the growing healthcare markets of Southeast Asia.

Let us be your partner in achieving seamless regulatory compliance across ASEAN — fast, accurate, and with a local touch.

For more information about our services or to tailor specific solutions, please contact our professional team.