Indonesia Independent License Holder

Maintaining the ability to change distributors, or sell directly to multiple regional distributors, is critical to a successful strategy in the dynamic Indonesian market. Applications for medical device registration to the Indonesian Ministry of Health (MoH) must be submitted and controlled by a local agent (AKA Sole Importer). An agent is granted power of attorney to hold the registration license on behalf of a foreign manufacturer. Licenses are non-transferable, and only one can be valid per device at one time.

Who can be the License Holder in Indonesia?

To be an Independent License Holder in Indonesia it’s required to be a locally registered business with a Medical Device Distribution License and Good Distribution Practice of Medical Devices (GDPMD) certified. Options are:

1. A legal subsidiary entity
2. A local distributor
3. An Independent Third Party like Asia Actual (certified IPAK)

The advantage to Independent License Holding in Indonesia is that only one entity can be the Product License Holder (awarded a Distribution Approval Number or NIE by the MoH). If a distributor is the Product License Holder and can’t adequately distribute the device and/or isn’t willing to turn over their right to distribution then the Manufacturer has very little leverage as multiple registrations with different distributors are not allowed nor are license transfers.

Asia Actual is a full-service provider of medical device license-holder services in Indonesia, specializing in working with regional distributors. Contracting with Asia Actual as an independent license holder allows you to:

• Sell to multiple regional distributors (avoiding mark-up by a national importer)
• Increase transfer pricing (as distributors are not investing in registration costs)
• Improve leverage in distributor negotiations/responses
• Add or change distributors as required
• Keep intellectual property away from local commercial agents

For more information about how to transfer local agents, please visit our Indonesia Medical Device Registration page.

Contact Asia Actual to see if our Indonesia Independent License Holding service is right for your business.