PT Dwipa Andakara Yasa

PT Dwipa Andakara Yasa is a licensed and fully compliant medical device distribution company based in Indonesia, with a strategic focus on spine and trauma solutions. Established to bridge global innovations and local clinical needs, we provide end-to-end regulatory, distribution, and technical support for international medical device manufacturers aiming to expand into the Indonesian healthcare market.

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Integrity

We uphold honesty, accountability, and transparency in all business dealings.

Commitment to Quality

We deliver only the highest standards in our products and services.

Strategic Partnership

We foster long-term relationships with principals and healthcare providers.

Regulatory Excellence

We stay aligned with all Indonesian regulatory requirements and best practices.

Customer-Centric Service

End-user satisfaction is our top priority.

What We Do?

At PT Dwipa Andakara Yasa, we provide a full-spectrum platform for international medical device manufacturers seeking access to the Indonesian market. With a focus on spine and trauma, we combine regulatory expertise, distribution strength, and clinical support—offering seamless entry and sustained growth in one of Southeast Asia’s largest healthcare markets.

License Holding & Regulatory Management

We serve as your official Marketing Authorization Holder (MAH) in Indonesia, managing product registration, regulatory compliance, and post-market obligations under local law.

Regulatory Consulting

Our in-house experts guide partners through complex Kemenkes requirements—particularly for non-radiological Class A–C devices.

E-Catalogue (e-Katalog) Strategy & Registration

Guidance and execution for product listing in Indonesia’s national healthcare procurement system.

Label Compliance & Local Adaptation

Translation and adjustment of labeling to comply with Indonesian regulatory standards.

License Amendment & Renewal

Support for changes in ownership, product updates, extensions, and other regulatory amendments.

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WHY US

Why Us?

Indonesia is the largest healthcare market in Southeast Asia, with rapidly increasing investments in hospital infrastructure and specialized care—including orthopedics and neurosurgery. Yet, navigating the regulatory environment and market dynamics remains challenging without a capable local partner.