This episode of ASEAN MedTech Insights dives deep into the specific clinical evidence requirements for AI-powered medical devices seeking market approval in Indonesia. We uncover why a standard CE mark or FDA clearance is often not enough and explore the nuances of demonstrating your product's efficacy for the diverse Indonesian population.

Imagine a MedTech company with a breakthrough AI diagnostic tool, already approved in the United States. They anticipate a quick entry into the large Indonesian market but are met with unexpected questions and delays from regulators. The core problem is that their clinical trials were conducted on a different demographic, and they now face the costly and time-consuming challenge of proving their algorithm works for Indonesian patients. This episode provides a roadmap to avoid that exact scenario.

Key questions answered in this episode:

- Why is simply having a CE mark or FDA approval not enough for AI device registration in Indonesia?

- What specific questions will the Indonesian Ministry of Health ask about your AI model's training data?

- How can you proactively demonstrate your algorithm's relevance to the diverse Indonesian population?

- What is a "local validation study," and when is it absolutely necessary?

- How does Indonesia's risk classification system impact the clinical data required for AI software?

- What is the most common mistake companies make when preparing their Clinical Evaluation Report for Indonesia?

- Are there strategies to justify using foreign clinical data without conducting a new, expensive local study?

Pure Global offers end-to-end regulatory consulting solutions for Medical Technology (MedTech) and In-Vitro Diagnostic (IVD) companies, combining local expertise with advanced AI and data tools to streamline global market access. Contact Pure Global at [email protected] or visit us at https://pureglobal.com.