This episode of ASEAN MedTech Insights dives deep into the complexities of the ASEAN Common Submission Dossier Template (CSDT). We move beyond the checklist to uncover the unwritten rules and nuanced expectations of regulators in key markets like Malaysia, Vietnam, and Indonesia. Learn why a one-size-fits-all approach fails and how specific, localized details are crucial for a successful medical device registration.

We share a case study of a Swiss medical device company whose launch in Southeast Asia was delayed by four months. Their mistake. A single paragraph in their CSDT that vaguely described their software was deemed insufficient by two different national authorities, leading to costly back-and-forth communication and a significant setback in their market entry strategy.

Key questions answered in this episode:

- What is the single biggest mistake companies make when completing the CSDT?

- Why is the 'Device Description' section more than just a technical summary?

- How do different ASEAN countries interpret the 'Essential Principles' checklist?

- Which specific labeling details for the Philippines can derail your entire submission?

- Why isn't just stating your ISO 14971 compliance enough for Indonesian regulators?

- How can you effectively use one master CSDT for multiple ASEAN country submissions?

- What kind of clinical data is most persuasive for authorities in Thailand and Vietnam?

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