Pure Global's ASEAN MedTech Insights: Navigating Indonesia's Regulatory Maze - Why Your Class A Medical Device Still Needs a Local Authorized Representative

Thinking of launching your Class A medical device in Indonesia? Many manufacturers assume that a low-risk classification means a simple, direct path to market. This common misconception can lead to costly delays and strategic dead-ends.

This episode of ASEAN MedTech Insights breaks down the essential requirement for a local authorized representative for ALL device classes in Indonesia. We uncover why the Indonesian Ministry of Health mandates this, and explore the critical, long-term implications of who you choose to hold your product license.

We share the story of a European diagnostic startup with an innovative Class A software as a medical device. They spent six months trying to navigate the system alone, only to discover their application couldn't be submitted without a local license holder. Their next mistake was hastily signing over representation to their first distributor, a decision that cost them control over their own market access just a year later.

This episode's key takeaways:
- Why is a local representative mandatory for even the simplest Class A devices in Indonesia?
- What is an IDAK license, and why is it non-negotiable for your local partner?
- Distributor vs. Independent Representative: What is the critical difference for your business long-term?
- How can tying your device registration to a distributor hold your market access hostage?
- What are the key documents needed for a Class A device submission in Indonesia?
- How does an independent representative give you more control and flexibility in the Indonesian market?
- What is the number one mistake foreign MedTech companies make when entering Indonesia?

At Pure Global, we specialize in providing that independent, expert local representation. We act as your partner on the ground, securing your product licenses while leaving you free to manage your commercial strategy. We offer end-to-end regulatory consulting, combining local expertise with advanced AI to streamline your market access across ASEAN and beyond.

Ready to secure your market access in Indonesia the right way? Contact us at [email protected] or visit https://pureglobal.com/ to learn more.