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
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:
Regulatory Requirement Compliance
Regulatory Requirement Compliance
A foreign manufacturer can set up a legal subsidiary entity in Indonesia with full investment. Alternatively, appointing a Local Authorised Representative (LAR) is also an option for registering and marketing medical devices. The LAR acts as a liaison with the Ministry of Health, ensuring that all regulatory requirements are met efficiently.
Streamlined Registration Process
Streamlined Registration Process
A LAR has the local expertise and understanding of regulatory procedures, helping to navigate complex documentation and submission requirements. This streamlines the registration process, reducing the risk of delays and rejections.
Local Market Insight
Local Market Insight
An LAR provides valuable insights into the Indonesian market, including regulatory changes, local standards, and best practices. This knowledge helps manufacturers adapt their products and strategies to better fit market demands.
Post-Market Surveillance and Compliance
Post-Market Surveillance and Compliance
The LAR is responsible for post-market activities, including monitoring device performance, handling adverse event reporting, and ensuring ongoing compliance with local regulations, which is crucial for maintaining market authorization.
Efficient Communication with Authorities
Efficient Communication with Authorities
As a local point of contact, the LAR facilitates effective communication with Indonesian regulatory authorities, helping to resolve issues quickly and ensure timely responses to any regulatory inquiries or requirements.
Legal Accountability and Representation
Legal Accountability and Representation
The LAR assumes legal responsibility for the device within Indonesia, handling product recalls, safety alerts, and regulatory audits. This reduces the manufacturer’s legal risks and ensures local accountability.
Enhanced Market Credibility
Enhanced Market Credibility
Having a reputable LAR enhances the credibility of your brand in the Indonesian market, reassuring healthcare providers and patients that your devices are backed by local expertise and support, which can lead to increased trust and market acceptance.
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.
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?
- The in-country representative must have a Medical Device Distribution License or Izin Distribusi Alat Kesehatan (IDAK) issued through Online Single Submission (OSS).
- Only a license holder may import the product according to Article 3 of the Ministry of Health Regulation no. 60 of 2017 “Supervision of Trade in Imported Medical Devices, In Vitro Diagnostic Medical Devices, and Household Health Supplies”
Can you appoint multiple marketing authorization holder or representatives in Indonesia?
- No, in Indonesia, foreign manufacturers are not allowed to appoint multiple in-country representatives for the same device as stated in the Ministry of Health Regulation no. 62 of 2017, Article 13.
- The foreign manufacturer must issue a Letter of Authorization (LoA) on company letterhead, signed and stamped by an officer of the company, authorizing the in-country representative to register the medical device.
- The LoA must be legalized by the local Indonesian Embassy.
- The letter of authorization has a validity of 2 years minimum up to a maximum of 5 years. The duration of this validity will also determine the length of time for the approval license of the medical device.
How Andaman Medical can help with in-country representation in Indonesia:
As your marketing authorization holder or local authorized representative in Indonesia we will:
- represent your company in all dealings with the Ministry of Health responsible for medical devices and in-vitro diagnostics including:
- registering your product
- importing your product
- submitting change notifications
- ensuring post-market surveillance once your product is authorized and placed in the market, including reporting Adverse Events and Field Safety Corrective Actions.
- facilitate the importation process including customs clearance
- maintain communication with appointed Distributors
- ensure that the medical device or IVD is correctly labelled
- accept all calls from the Ministry of Health regarding the foreign manufacturer and its products and liaising accordingly with the foreign manufacturer including
- maintain our office including a telephone and email connection in Indonesia
- monitor regulations to alert you to any changes or new regulations applicable to your product