Navigating Indonesia's MedTech Maze: Why Your Local Representative is Key to Market Access with P... скачать в хорошем качестве

Navigating Indonesia's MedTech Maze: Why Your Local Representative is Key to Market Access with P...

This episode of ASEAN MedTech Insights tackles a critical hurdle for global MedTech companies eyeing the Indonesian market: the mandatory appointment of a Local Authorized Representative (LAR). We explore why this is more than a procedural step and how the right partner can make or break your market access strategy. Imagine spending months preparing your technical dossier, only to have your product registration in Indonesia tied to an underperforming distributor. You're losing sales and want to switch partners, but you can't. The distributor, acting as your LAR, owns the product license. You are now faced with either losing market presence for over a year to re-register, or staying in a partnership that hurts your brand. This episode explains how to avoid this common and costly pitfall. Key questions from this episode: 1. What specific license must a company hold to be a Local Authorized Representative in Indonesia? 2. Why is appointing your distributor as your authorized representative a significant business risk? 3. What happens to your product registration if you terminate your relationship with a distributor who also acts as your LAR? 4. How does separating your regulatory representative from your commercial distributor give you more control? 5. What are the essential documents, like ISO 13485, required for the registration process? 6. How can an independent LAR streamline your entry and long-term strategy in the Indonesian market? 7. What are the legal responsibilities of an LAR for your medical device in Indonesia? Pure Global offers end-to-end regulatory consulting solutions, acting as your independent local representative in Indonesia and over 30 other markets. We use local expertise and advanced AI tools to streamline global market access, ensuring you maintain full control of your assets. Let us help you navigate the complexities of global expansion. Contact Pure Global at [email protected] or visit us at https://pureglobal.com/.