Program

Day 1 September 15 (Tue)

Session

Indonesia Market Entry Strategies Guided Directly by Regulatory Authorities

The Indonesian Ministry of Health provides direct guidance on medical device policies and registration systems,
along with practical strategies essential for entering the local market—from government procurement to hospital market access.

Partner Organizations
Time Title Speaker
16:00 - 16:05 (05’) Opening Remarks Hwang Sungeun
KHIDI
Director
16:05 - 16:50 (45’) Medical Device Registration Indonesia Danang Adiktriawan
Ministry of Health, Indonesia
Officer
16:50 – 17:35 (45’) Indonesia Medical Device Policy Deni Herdiana
Ministry of Health, Indonesia
Head of Team
17:35 – 18:00 (25’) Strategies for Entering the Indonesian Medical Device Market Shin Sung-ho
Overseas Medical Device Support Center (Indonesia)
Director

Speakers

You can click on each speaker to view their Professional Experience and Abstract.

  • Danang Adiktriawan
    16:05 - 16:50 Medical Device Registration Indonesia
    Danang Adiktriawan
    Ministry of Health, Indonesia
    Junior Administration Officer
    Close
    Danang Adiktriawan
    Danang Adiktriawan

    Ministry of Health, Indonesia
    Junior Administration Officer

    16:05 - 16:50
    • Professional Experience

      To be updated

    • Abstract

      This presentation outlines Indonesia’s strategic direction for developing its medical device industry and examines key policies and regulatory frameworks. It will cover initiatives to expand local manufacturing and strengthen industrial capacity, as well as recent policy changes such as the halal requirements for medical devices. The session will also highlight essential regulations that foreign manufacturers must understand when entering the Indonesian market.

  • Deni Herdiana
    16:50 - 17:35 Indonesia Medical Device Policy
    Deni Herdiana
    Ministry of Health, Indonesia
    Head of the Evaluation Working Team for Class A and B Imported Medical Devices
    Close
    Deni Herdiana
    Deni Herdiana

    Ministry of Health, Indonesia
    Head of the Evaluation Working Team for Class A and B Imported Medical Devices

    16:50 - 17:35
    • Professional Experience

      He is the Head of the Class A and B Imported Medical Device Evaluation Team at the Indonesian Ministry of Health. After working in Class B medical device evaluation and management, he now oversees the assessment of imported medical devices. He has a professional background in pharmacy and public health.

    • Abstract

      This presentation provides an overview of Indonesia’s risk based medical device registration system and the regulatory procedures for imported medical devices. It will outline the key requirements and considerations that companies must prepare for during the product registration process. The session will also cover compliance obligations for medical device distributors and post market requirements that manufacturers and importers must follow after registration, highlighting essential regulations for successful market entry.

  • Shin Sung-ho
    16:35 - 18:00 Strategies for Entering the Indonesian Medical Device Market
    Shin Sung-ho
    Overseas Medical Device Support Center (Indonesia)
    Director
    Close
    Shin Sung-ho
    Shin Sung-ho

    Overseas Medical Device Support Center (Indonesia)
    Director

    16:35 - 18:00
    • Professional Experience

      He has provided local business consulting for medical equipment in Indonesia’s EDCF hospital projects and, since 2013, has operated the Indonesia Overseas Medical Device Support Center, assisting Korean medical device companies in entering the local market.

    • Abstract

      This presentation examines the practical issues companies encounter when entering the Indonesian medical device market, including product registration, CDAKB requirements, local distribution structures, hospital market access, and government procurement. It will provide a step by step explanation of how key procedures—such as INAPROC e Catalog registration, government procurement mechanisms, access to hospital and clinic markets, and selecting local distributors and partners—connect to real market entry and commercialization.