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