Letter of Authorization (LoA)
What Is the LoA?
The Letter of Authorization (LoA) is the formal document by which a foreign manufacturer appoints its Indonesian Local Authorized Representative (LAR) for a specific medical device or range of devices. It is a mandatory document in every NIE registration dossier and is one of the most frequently cited causes of dossier rejection.
Mandatory Requirements
| Requirement | Detail |
|---|---|
| Language | English (accepted); Bahasa Indonesia translation may be requested |
| Validity period | Must be valid for at least 5 years from the date of submission |
| Alignment with NIE | LoA validity must cover the full intended NIE 5-year validity period |
| Notarisation | Must be notarised by a qualified notary in the manufacturer's country |
| Legalisation / Apostille | Must be legalised at the Indonesian embassy in the manufacturer's country, OR apostilled (for countries party to the Hague Apostille Convention) |
| Named parties | Must clearly name the manufacturer (with exact company name, address, and country) and the Indonesian LAR (exact company name and IDAK number) |
| Device scope | Must specify the device(s) or product categories being authorised |
The 5-Year Validity Rule — Critical
The most frequent reason for NIE application rejection related to the LoA is a validity period shorter than 5 years. Kemenkes evaluators will reject the application if the LoA is not valid for at least 5 years from the submission date.
Best practice: Issue the LoA for the maximum reasonable period (5–7 years), clearly timed to exceed the 5-year NIE validity cycle.
Legalisation vs Apostille
The correct process depends on whether your country has ratified the Hague Apostille Convention (1961):
| Scenario | Process |
|---|---|
| Manufacturer's country is an Apostille Convention member | Obtain apostille stamp from the designated authority in your country |
| Manufacturer's country is NOT a Convention member | Full consular legalisation through the Indonesian embassy in your country |
Common Apostille Convention members: EU countries, UK, USA, Australia, Japan, Singapore, South Korea.
Preparing the LoA: Practical Tips
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Exact name consistency — The manufacturer name on the LoA must match exactly with the ISO 13485 certificate, the Free Sale Certificate, the GMP certificate, and the device label. Even minor differences (e.g. "Ltd" vs "Limited") can trigger rejection.
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Company address — Use the registered company address, consistent across all documents.
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Plan early — Embassy legalisation can take 4–12 weeks depending on the country. This is one of the longest lead-time items in the pre-submission process.
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Device scope — Define scope broadly enough to cover your current and near-term product portfolio, avoiding the need for new LoAs for each product addition.
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Original vs copy — Kemenkes generally requires submission of the original apostilled/legalised document or a certified true copy. Confirm current requirements with your LAR.