Why medical device registration in Indonesia works differently

Since 2009, we have supported more than 2000 medical device registrations, and the first question that almost always comes up from foreign manufacturers is: "Why does this process feel more complex than back home?"

The answer comes down to one principle that gets overlooked: in Indonesia, the Izin Edar (market authorization) is tied to the license holder, not just the product. International manufacturers without a legal entity in Indonesia are required to appoint a Local Authorized Representative (LAR), who carries regulatory responsibility on their behalf.

This guide walks through the full medical device registration process in Indonesia for 2026, from product classification to post-market obligations, based on the Permenkes 11/2025 framework now in full effect.

Step 1: Determine your product's risk classification

Every medical device in Indonesia is classified by risk level:

• Class A low risk
• Class B moderate risk
• Class C high risk
• Class D highest risk

This classification determines which technical documents are required, the evaluation pathway, and the estimated timeline. The most common mistake we see: manufacturers assume Indonesia's risk classes map directly onto their home country's classes, when the criteria are not always identical.

Step 2: Choose your market entry path

There are two main routes:

• Setting up your own PT in Indonesia - gives full control over the license, but requires significant time and capital to establish the legal entity, office, and staff.
• Partnering with a Local Authorized Representative - a legally registered Indonesian company that holds the Izin Edar on your behalf, offering a faster and more capital-efficient route.

We usually advise clients to choose based on the scale of their long-term business plan, not just short-term speed.

Step 3: Prepare the technical dossier

The technical dossier for registration includes clinical evidence, safety testing results, product standards compliance, and labeling adapted to Indonesian requirements. Documentation from your home country (CE, FDA, NMPA) can serve as a base, but still needs to be reformatted, translated, and evaluated by the Ministry of Health.

Step 4: Verify CDAKB compliance

Any entity distributing medical devices in Indonesia, including a LAR, must hold CDAKB certification (Indonesia's good distribution practice standard, roughly equivalent to GDP). This is separate from the Izin Edar, but the two need to stay aligned.

Step 5: Submit registration and track the process

Registration timelines typically range from 1 to 3 months, depending on risk class and documentation completeness. The process runs through the Ministry of Health's online system, and regular communication with the evaluator often determines how quickly follow-up questions get resolved.

Step 6: Manage post-market obligations

Once the Izin Edar is issued, the obligations do not stop. Post-market surveillance, adverse event reporting, and annual CDAKB audits continue for as long as the product is on the Indonesian market. Many companies treat registration as the finish line, when it is really the start of an ongoing compliance obligation.

The most common mistakes we see

• Assuming the Izin Edar is tied to the product rather than the license holder
• Underestimating registration timelines and committing to a launch date too early
• Appointing a distributor before the Izin Edar is active (a criminal offense under Indonesian law)
• Assuming international certification (ISO 13485, CE) automatically satisfies CDAKB requirements

Conclusion

Medical device registration in Indonesia is not a single step, but a chain of connected decisions, from product classification through to long-term compliance. Manufacturers who build their regulatory strategy early, rather than after a launch date is already set, consistently reach the market faster.

PT. Deray Global Utama is an Indonesia-based regulatory consultancy with over 15 years of experience supporting medical device registration. Reach us at info@derayglobalutama.com for an initial consultation.