When setting up your own PT makes sense

Not every manufacturer needs to establish its own legal entity in Indonesia. We usually recommend this route for companies planning long-term operations, wanting full control over the license, or with product volume large enough to justify the higher upfront investment compared to appointing a Local Authorized Representative (LAR).

Here are the steps to setting up a medical device PT in Indonesia for 2026.

Step 1: Determine your ownership structure

Foreign manufacturers generally set up a PT PMA (foreign investment company). This structure allows full foreign ownership for most medical device business categories, but remains subject to the Positive Investment List and minimum capital requirements. [Insert the latest minimum authorized and paid-up capital figures for PT PMA, as these are revised periodically]

Step 2: Choose the correct KBLI code

Indonesia's Standard Business Classification (KBLI) code determines which business license you can apply for. For medical device distribution, the KBLI code has been updated under KBLI 2025, and companies still using the old code are required to transition before the deadline.

Step 3: Handle the deed of establishment and legal entity approval

This step involves a notary drafting the deed of establishment, followed by approval through the Ministry of Law. The company name, shareholder structure, and articles of association are set at this stage.

Step 4: Register your NIB through the OSS RBA system

The Business Identification Number (NIB) is issued through the Online Single Submission Risk- Based Approach (OSS RBA) system. For medical device businesses, this NIB becomes the basis for applying for derivative business licenses, including distribution permits.

Step 5 : Request IDAK and CDAKB Certification

Once the NIB is issued, any company distributing medical devices must obtain CDAKB certification (Indonesia's good distribution practice standard). This includes a facility audit, storage system review, and product handling procedures.

Step 6: Prepare your team and facilities to meet the standard

The Ministry of Health evaluates operational readiness, including warehouse facilities, product tracking systems, and personnel responsible for regulatory compliance. This is a step manufacturers used to lighter processes back home often underestimate.

Step 7: Only then does product registration begin

Setting up the PT is a prerequisite, not the end goal. Once the legal entity and CDAKB certification are in place, per-product Izin Edar registration can begin, with timelines varying by risk class.

Own PT vs LAR: which is faster

In our experience, the own-PT route takes 6 to 18 months before you are ready to register your first product, while partnering with a LAR that already holds active CDAKB certification can cut that time significantly, since the legal infrastructure is already in place. The trade-off is control: your own PT gives full control, a LAR means sharing some of that control with a partner.

Conclusion

Setting up a medical device PT in Indonesia is a sound long-term investment for manufacturers with a serious commitment to this market. But the decision should be made after comparing it against the LAR option, not treated as the default step. If you are weighing which structure fits your business plan, we can help you compare. Reach us at info@derayglobalutama.com.