How to Register a Medical Device in Indonesia

This video provides a comprehensive guide for medical device manufacturers looking to enter Indonesia, Southeast Asia’s fastest-growing medtech market. It outlines the tremendous growth potential (driven by a large population, strong national health insurance coverage, and increased healthcare investment) while explaining the regulatory requirements that every foreign manufacturer must meet to gain market access.

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Topics covered in this video include:

• Indonesia’s medical device market size, growth drivers, and future outlook
• The role of NADFC and MoH in regulating medical devices
• Risk-based device classification and its impact on registration timelines
• The importance of appointing a local representative/licence holder
• Core requirements for technical dossiers, labeling, and post-market compliance
• How Pure Global simplifies the registration process from start to finish

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Indonesia is often called the region’s “sleeping giant” for medical technology. With a population of 275 million, nearly 90% health insurance coverage, and significant investment in medical infrastructure and medical tourism, the market is forecast to grow to US $3.66 billion by 2029 (7.26% CAGR). The IVD segment alone is expected to hit US $470 million. This rapid growth presents enormous opportunities for innovative medical device companies, but only for those who can navigate the strict requirements of the National Agency of Drug and Food Control (NADFC) and Ministry of Health (MoH).

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The video breaks down Indonesia’s risk-based device classification system, which dictates the evidence and documentation needed for registration, from device descriptions and safety data to QMS certificates and product labeling in Bahasa or English. Every foreign manufacturer must appoint a licensed Indonesian importer or local representative, as this entity holds your registration licence.

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Need MoH approval?
Pure Global acts as both a regulatory consultant and in-country representative, handling everything from classification and dossier preparation to liaising with MoH and managing post-market vigilance. Using AI-powered compliance tools and a harmonized documentation process, Pure Global can help manufacturers accelerate approvals in Indonesia and unlock opportunities in 30+ other markets. Pure Global offers end-to-end support to streamline your medical device registration in Indonesia.

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