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Indonesia · Product registration

Local authorized representative in Indonesia

BPOM, the Ministry of Health, and BPJPH issue product licenses only to Indonesian legal entities, so a foreign company needs a local holder. That holder, the local authorized representative, is the registrant on record. Who holds it decides how much control you keep over your own products.

Local authorized representative in Indonesia — Emerhub
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Overview

What a local authorized representative is

A local authorized representative is the Indonesian entity that holds your product registration when you have no company of your own in the country. Across product registration, a foreign company cannot hold the license directly, so the regulator issues it to a local holder instead.

The holder is the registrant on record. It is the entity accountable to BPOM, the Ministry of Health, or BPJPH for the product, and the name attached to the license. It files the registration, keeps it current, and answers for compliance once the product is on the market.

A license is issued to a single holder, and for many products it cannot simply be moved to another. That makes the choice of representative a commercial decision, not just an administrative one.

The three models

Three ways to hold your license

Every route puts the license with an Indonesian entity. They differ in how much control you keep.

Your own PT PMA

You set up a foreign-owned company and hold the license yourself. This gives full control over registration and distribution, but it carries the capital and upkeep of a company.

A distributor as holder

Your distributor holds the license. It is the cheapest way in, but the registration sits with them for the life of the contract, which ties your market access to one partner.

An independent representative

A neutral party such as Emerhub holds the license and does not compete as your distributor. You keep control of the registration and can appoint or change distributors freely.

The risk to weigh

The catch with a distributor-held license

The license is the asset that lets a product be imported and sold. When a distributor holds it, that asset sits on their side of the table. If the relationship sours or you simply outgrow them, you cannot take the registration with you the way you might expect.

An independent holder separates the license from distribution. The registration stays in neutral hands, so you can run one distributor or several, replace an underperformer, or move into direct sales without your market authorization being at risk.

A license is issued to one holder and is generally not transferable. Moving a distributor-held registration usually means canceling it and applying again under a new holder, which needs the original holder’s cooperation. For medical devices, a manufacturer who cannot secure that cooperation faces a six-month wait before reapplying.
The holder’s role

What the holder is responsible for

Holding the license is an ongoing duty, not a one-time filing.

  • Holding the Izin Edar, NIE, or notification on record
  • Filing the registration, renewals, and variations
  • Keeping labels matched to the approved submission
  • Acting as importer of record where the setup requires it
  • Filing the reports each regulator requires, such as the semi-annual device report through Regalkes
  • Being the point of contact for regulator queries and inspections
  • Managing recalls and withdrawals if they arise
The process

How Emerhub holds your license

From appointment to a registration that stays in your control.

Step 1 — Appoint Emerhub

You authorize Emerhub as your local representative through a Letter of Authorization.

Step 2 — Register the product

We register your product under our licensed Indonesian entity and hold the resulting license or notification.

Step 3 — Maintain compliance

We handle renewals, variations, labeling checks, and the reporting each regulator requires.

Step 4 — Keep distribution open

You appoint, change, or run several distributors while the license stays in neutral hands.

Common questions

Local representative questions

What foreign companies ask about holding a license.

Can a foreign company hold an Indonesian product license directly?

No. BPOM, the Ministry of Health, and the other regulators issue licenses only to Indonesian legal entities. A foreign company registers through its own local company, a distributor, or an independent representative.

What happens if my distributor holds the license?

The registration sits with them. Because it is issued to one holder and is generally not transferable, switching distributors usually means canceling the license and applying again, which needs the original holder’s cooperation.

Can I move a license to a new holder?

Not directly in most cases. The existing license is canceled and a new one filed under the new holder. For medical devices, a manufacturer who cannot secure the current holder’s cooperation faces a six-month wait before reapplying.

Does an independent representative control my product?

No. You keep ownership of the product and your commercial relationships. An independent holder such as Emerhub holds the license in neutral hands and does not compete as your distributor, so you can change distributors without losing the registration.

What is a Letter of Authorization?

The document by which a foreign manufacturer authorizes a local entity to hold and act on its product registration. It is the basis for the representative’s role.

Can one representative cover different product types?

Yes, as long as it holds the right underlying licenses for each track, such as IDAK for medical devices. A single representative can hold registrations across BPOM, the Ministry of Health, and other regulators.

On the ground in Jakarta

Talk to our Indonesia team

Tell us the product, the regulators it falls under, and the distribution arrangements you have today. Our Jakarta team will hold your license in neutral hands and keep the registration in your control as your channel arrangements evolve.

Phone+62 21 2205 7930
OfficeSatrio Tower, Floor 6, Unit 5
RT.7/RW.2, Kuningan
Jakarta 12950, Indonesia