NIE Renewal
Renewal Is Mandatory
The NIE is valid for 5 years from the date of issuance. After 5 years, it must be renewed — it does not automatically extend. If the NIE lapses without renewal, the device cannot be legally imported or distributed until a new NIE is obtained (which requires a new full registration submission).
When to Start the Renewal Process
Begin renewal preparation at least 12 months before expiry. Key reasons for this lead time:
- Renewal involves updating documents that may have expired (ISO 13485, LoA, CFS/FSC, GMP certificate)
- Document legalisation (apostille/embassy) takes 1–3 months
- Regalkes submission review takes 1–3 months (administrative + technical)
- If the renewal is not approved before expiry, there may be a gap period during which distribution must cease
Documents Required for Renewal
Renewal requires re-submission of updated documents through Regalkes. At minimum:
| Document | Notes |
|---|---|
| Updated Letter of Authorization | New validity period; re-apostilled |
| Updated ISO 13485 certificate | Must be current and in scope |
| Updated GMP certificate / Free Sale Certificate | Current versions |
| Updated labeling | Incorporating any changes made during the prior NIE period; BI compliant |
| Updated risk management summary | Reflecting any new post-market information |
| PMS data summary | Summary of post-market surveillance findings during the prior registration period |
| Change history | Summary of any changes made to the device since original registration |
LoA Validity Alignment
One of the most important aspects of renewal is ensuring the LoA validity aligns with the new NIE 5-year period. If the existing LoA expires before or shortly after the renewed NIE would expire, Kemenkes may reject the renewal application.
Best practice: Prepare a new LoA at each renewal with validity extending at least 5 years from the renewal submission date.
Consequences of NIE Lapse
If an NIE lapses:
- All imports against that NIE must cease immediately
- Any stock in Indonesia under the lapsed NIE may continue to be sold if already in the supply chain, but no new imports are permitted
- Re-registration requires a new full NIE application — not an expedited process
- There is no guaranteed continuity of market access during the re-registration period