Pure Global Presents: Your Strategic Roadmap to Medical Device Licensing in Indonesia & ASEAN - Demystifying MOH Regulation No. 62 of 2017

This episode of ASEAN MedTech Insights provides a deep dive into the essential requirements of Indonesia's Minister of Health Regulation No. 62 of 2017. We break down the critical pillars for medical device registration, including the mandatory appointment of a local license holder, the four-tier risk classification system, and the meticulous documentation required in the CSDT format. We move beyond the legal text to explore the practical realities and strategic challenges that foreign manufacturers face. This is not just a theoretical overview; it's a strategic guide filled with real-world observations to help you successfully navigate the regulatory maze and unlock market access in one of ASEAN's most dynamic MedTech landscapes. Here's a challenging scenario we've seen. A leading European stent manufacturer with full CE certification expected a swift entry into Indonesia. Instead, they faced a two-year delay, countless rejections, and mounting costs. Why. Their local partner fumbled the Common Submission Dossier Template (CSDT) submission, a specific and rigid format required by Regulation 62. This single administrative misstep cost them millions in potential revenue and gave competitors a crucial head start. What You'll Learn: 1. Why is choosing your local Indonesian partner the most critical decision you'll make before submission? 2. What is the CSDT, and why does simply having FDA or CE approval not guarantee a smooth registration in Indonesia? 3. How does Indonesia's four-tier risk classification (A, B, C, D) directly impact your budget and timeline? 4. Are there specific labeling and language requirements under Regulation 62 that can lead to an automatic rejection? 5. What post-market surveillance duties are you legally responsible for even after your device is approved? 6. How does Regulation 62 align with the broader ASEAN Medical Device Directive, and what does this mean for your regional strategy? 7. What are the most common documentation errors that cause significant delays for foreign MedTech companies? Navigating Indonesia’s regulatory framework doesn’t have to be a journey of trial and error. Pure Global offers end-to-end regulatory consulting solutions, combining local expertise with advanced AI to streamline your market access. For a strategic partner who can manage your entire product lifecycle in Indonesia and beyond, contact us at [email protected] or visit our website at https://pureglobal.com/ to learn more.

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