Navigating IDAK & CDAKB Requirements for Indonesia Market Entry: A Case Study

Entering Indonesia’s healthcare market is a significant opportunity for medical device companies. However, this move comes with strict regulatory requirements. To legally import and distribute medical devices in Indonesia, businesses must secure the IDAK license (Medical Device Distribution Permit) and comply with CDAKB requirements (Good Distribution Practice for Medical Devices).

These certifications ensure companies maintain high-quality storage, distribution, and product handling standards. Without these, a business may encounter operational standstills, legal challenges, or even exclusion from specific markets.

The following case study shows how InCorp assisted a Shenzhen-based medical device company to overcome such difficulties and establish a solid position in Indonesia.

Challenges of Entering the Indonesian Market

A Shenzhen-based medical device company aimed to establish a foothold in Indonesia’s growing healthcare market. 

Their primary objectives were to set up a 100% foreign-owned entity, obtain necessary licenses, and ensure compliance with Indonesia medical device registration regulations to import and distribute their products effectively.

However, the client faced several challenges in meeting the requirements for IDAK Indonesia and CDAKB compliance; these are:

Licensing Procedure Complexity

The process for obtaining an IDAK license and fulfilling CDAKB requirements included substantial documentation, inspection, and auditing, which the client found quite intimidating since the client was not experienced in Indonesia’s regulatory environment.

Operational Infrastructure Establishment

The client needed to set up a physical office and a compliant warehouse to qualify for licensing. Hiring a Technical Person in Charge (PJT) with relevant expertise added another layer of complexity.

Limited Market Knowledge

Understanding Indonesia’s medical device market, including sales trends and distribution dynamics, was critical for creating a viable market entry strategy. However, the client lacked insights into these essential factors.

How InCorp Addresses Challenges with Product License Holder Services

InCorp Indonesia implemented a comprehensive approach to address the client’s regulatory, operational, and market entry challenges.

Comprehensive Support for IDAK License Application

We guided the client through the entire process of obtaining their IDAK license, which included:

• Preparing and submitting the required documentation to regulatory authorities.
• Coordinating inspections and audits to meet all legal standards.
• Ensuring timely follow-ups to expedite the approval process.

Ensuring Compliance with CDAKB Requirements

To meet CDAKB requirements, we provided:

• Warehouse inspection support to verify compliance with Good Distribution Practices.
• Recruitment of a Technical Person in Charge (PJT) with expertise in managing regulatory obligations.
• Training and consultation to align operational processes with CDAKB standards.

Strategic Guidance to Indonesia Medical Device Registration

We undertook the step-by-step registration of medical devices to conform to Indonesia medical device registration laws. We further provided guidance on how to improve post-registration distribution networks through engagement with sub-distributors.

Operational and Market Insights

To address the client’s market knowledge gap, we provided:

• Analysis of Indonesia’s medical device market, including competitor trends.
• Strategic recommendations for pricing, positioning, and distribution strategies.
• Guidance on leveraging partnerships to strengthen market presence.

Key Results Achieved

With InCorp advisory and customized solutions, our client has overcome the complex issues associated with Indonesia’s medical device market.

From getting key licenses to creating a strategic foothold, our advisory ensured that this market entry process was swift and effective. Following are some of the key results from our advisory:

Successful IDAK License Approval

The client got their IDAK license within the projected timeline, enabling them to import and distribute medical devices in Indonesia legally.

Full Compliance with CDAKB Requirements

With our guidance, the client complied with all the requirements set by CDAKB, ensuring that it followed Good Distribution Practices and maintained high standards for storage and distribution.

Seamless Product Registration

All medical devices were registered without delays, meeting the rigorous standards of Indonesia medical device registration and enabling the client to enter the market without disruptions.

Effective Market Entry Strategy

Our tailored advice helped the client to establish a strong distribution network by appointing sub-distributors. This strategic approach guaranteed them a competitive advantage in the vibrant Indonesian healthcare market.

Why Outsourcing is Important for Healthcare Business

For companies looking to enter Indonesia’s healthcare market, outsourcing regulatory and operational tasks will ensure the following:

• Compliance with Licensing Requirements: Avoid risks by meeting the demands of IDAK Indonesia and CDAKB standards.
• Operational Efficiency: Streamline processes for office setup, warehouse inspections, and personnel recruitment.
• Strategic Market Insights: Gain valuable knowledge of sales trends and competitor strategies.
• Cost and Time Savings: Focus resources on growth while experts handle regulatory complexities.

Why Choose InCorp for Outsourcing Your Healthcare Business

InCorp specializes in facilitating seamless market entry for medical device companies. Our expertise ensures businesses can navigate Indonesia’s complex regulatory landscape with ease.

Proven Success in IDAK Licensing

Our team excels in securing IDAK licenses, enabling clients to comply with all regulatory requirements.

Expertise in CDAKB Compliance

We provide end-to-end assistance to meet CDAKB requirements, from inspections to operational training.

End-to-End Market Entry Solutions

From Indonesia medical device registration to creating a distribution strategy, we handle all aspects of market entry.

Strategic Market Insights

Our actionable intelligence equips clients with the tools to succeed in Indonesia’s competitive healthcare market.

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Simplify Your Market Entry with InCorp

InCorp Indonesia simplifies market entry for medical device companies by offering end-to-end solutions for regulatory compliance, operational setup, and strategic market positioning. Our core services include:

• Medical Device Licensing Support: Support for obtaining IDAK and compliance with CDAKB requirements.
• Product Registration: Compliance with the standards for Indonesia medical device registration.

Establish your medical device business and secure your necessary license in Indonesia by filling out the form below.