Local Authorised Representative in Indonesia

Expanding into Indonesia’s medical device market can be challenging without local expertise. That’s where Andaman Medical comes in.

As a trusted Local Authorised Representative (LAR) in Indonesia, we provide the local expertise and regulatory support you need to ensure seamless market entry and compliance. From handling complex requirements to ensuring your products meet all regulatory standards, we take care of the details—so you can focus on bringing your medical innovations to those who need them most.

Why Get Local Authorised Representative in Indonesia

Appointing a Local Authorised Representative (LAR) in Indonesia isn’t just about meeting regulatory requirements—it’s about ensuring your medical device gains smooth market entry and long-term success in this dynamic and competitive market.

At Andaman Medical, we specialise in providing reliable and expert LAR services to support your business. With our deep understanding of Indonesia’s regulatory landscape, we act as your trusted in-country representative, ensuring full compliance with the Indonesian Ministry of Health (MoH) regulations, managing communications with regulatory authorities, and handling all necessary post-market activities.

Here is why having a Local Authorised Representative (LAR) in Indonesia is important:

Why Choose Andaman Medical for Your In-Country Representation in Indonesia?

What You Need to Know About Having a Local Authorised Representative in Indonesia

Licence Requirement

The in-country representative must have a Medical Device Distribution License, known as Izin Distribusi Alat Kesehatan (IDAK), issued through Online Single Submission (OSS). In addition, the in-country representative must have a Good Distribution Practice for Medical Devices (GDPMD) certificate.

Single Representative Rule

Foreign manufacturers cannot appoint multiple in-country representatives for the same device, as stated in the Ministry of Health Regulation no. 62 of 2017, Article 13.

Import Restriction

Only the license holder can import the product, as specified in Article 13 of the Ministry of Health Regulation no. 60 of 2017.

Letter of Authorisation (LoA)

  • Issuance: The foreign manufacturer must provide a Letter of Authorisation (LoA) on company letterhead, signed and stamped by an officer of the company.
  • Legalisation: The LoA must be legalised by the local Indonesian Embassy. However, for a country party to the Apostille Convention, it is acceptable to apostilled LoA instead of legalising it by the Indonesia Embassy.
  • Validity: The LoA must be valid for a minimum of 2 years and a maximum of 5 years. This validity period determines the approval license duration for the medical device.

Navigating the role of a Local Authorised Representative in Indonesia can be complex, but Andaman Medical is here to simplify the process and ensure you remain fully compliant. Connect with our experts today and take the first step toward seamless representation!

Local authorised representative in Indonesia

The Ministry of Health in Indonesia requires foreign manufacturers who have not set up their own legal subsidiary to appoint a Local Authorised Representative (LAR), sometimes referred to as the in-country representative or marketing authorization holder.

Andaman Medical has been a local authorized representative in Indonesia since 2016.

What are the requirements for a marketing authorization holder or LAR in Indonesia?

Can you appoint multiple marketing authorization holder or representatives in Indonesia?

How Andaman Medical can help with in-country representation in Indonesia:

As your marketing authorization holder or local authorized representative in Indonesia we will:

Get a quote for in-country representation services in Indonesia

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