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Local Authorized Representative (LAR)

The Mandatory Requirement​

Foreign manufacturers cannot submit a medical device registration directly to Kemenkes. Indonesia requires all foreign manufacturers to appoint an Indonesian legal entity to act as their Local Authorized Representative (LAR). This is not optional — it is a mandatory precondition for any device registration.

The LAR:

  • Must be an Indonesian company legally incorporated under Indonesian law
  • Must hold a valid IDAK (Medical Device Distribution Licence)
  • Must hold a valid CDAKB (Good Distribution Practice certificate)
  • Becomes the NIE holder — the legal owner of the product registration in Indonesia
  • Is the official point of contact with Kemenkes for all regulatory matters

Roles and Responsibilities of the LAR​

ResponsibilityDescription
NIE applicationSubmits the registration dossier via Regalkes on behalf of the manufacturer
NIE holderLegally owns the NIE for the duration of validity
Regulatory liaisonSingle point of contact with Kemenkes for queries, clarifications, renewals
Adverse event reportingObligated to report device-related adverse events to Kemenkes
Post-market surveillanceImplements PMS activities, maintains traceability records
FSCA coordinationManages field safety corrective actions and recalls in Indonesia
Change notificationsSubmits change notifications via Regalkes for product modifications
Import coordinationParticipates in the import clearance process (SKI per shipment)

Who Can Act as LAR?​

There are three main structures for appointing a LAR:

1. Commercial Distributor as LAR​

Your Indonesian commercial distributor also holds the NIE. Convenient and cost-effective in the short term, but creates significant long-term risks:

  • The distributor "owns" your NIE — if the relationship ends, they retain control of the registration
  • You cannot switch distributors without losing market access until the NIE expires or is cancelled
  • Distributor has leverage over pricing and exclusivity negotiations

2. Foreign-Owned Company (PT PMA)​

Establish your own Indonesian subsidiary (PT PMA) and hold the NIE in your own entity. Maximum control, but requires significant investment (~IDR 10 billion minimum) and time to set up.

3. Neutral Licence Holder​

Appoint an independent professional licence-holding service as the NIE holder (separate from your commercial distributor). This is increasingly the preferred approach for foreign manufacturers — see Neutral Licence Holder.

Due Diligence on Your LAR​

Before appointing any entity as your LAR, verify:

  • Current valid IDAK certificate (check expiry date)
  • Current valid CDAKB certificate (check expiry date)
  • Track record with Kemenkes (any history of NIE suspensions or sanctions)
  • Financial stability
  • Regulatory affairs capability (internal team or outsourced?)
  • Experience with your device type and risk class

Letter of Authorization​

The formal appointment of your LAR is documented in a Letter of Authorization (LoA). This is one of the most critical documents in the registration dossier. See Letter of Authorization for full requirements.