Skip to main content

Submission Steps — Regalkes

Overview of the Submission Process​

Medical device registration in Indonesia follows a defined multi-step process through the Regalkes portal. Here is the complete sequence:

Step 1: Pre-Submission Preparation​

Before opening the Regalkes portal, ensure:

  • LoA is apostilled/legalised and validity covers 5+ years
  • Free Sale Certificate (CFS/FSC) is apostilled/legalised
  • GMP certificate is current and covers the manufacturing site
  • ISO 13485 certificate is current and scope covers the device
  • ASEAN CSDT dossier is fully assembled
  • All labels are finalised in Bahasa Indonesia
  • Device classification has been confirmed
  • LAR holds current IDAK + CDAKB

Step 2: Establish Online Registration​

The LAR registers the company's profile in the Regalkes system, linked to their IDAK via OSS. This is typically done once and reused for all subsequent submissions.

Step 3: Create New Application​

The LAR logs in to regalkes.kemkes.go.id and creates a new device registration application, selecting:

  • Device type (general medical device, IVD, or PKRT)
  • Risk class
  • Brand/trade name
  • Manufacturer details

Step 4: Upload Documents​

All required documents are uploaded in PDF format following Regalkes file naming conventions. Key documents include:

  • LoA (apostilled)
  • CFS/FSC (apostilled)
  • GMP certificate
  • ISO 13485 certificate
  • Device description and intended use
  • Risk analysis summary (ISO 14971)
  • Clinical evidence (class-dependent)
  • Labels (BI-compliant)
  • Technical specifications and test reports
File naming

Regalkes enforces specific file naming conventions. Non-compliant file names cause upload errors. Ask your LAR for the current naming format required — this changes periodically.

Step 5: Administrative Review​

Kemenkes evaluators check:

  • Document completeness
  • Document consistency (name/address matching across all documents)
  • LoA validity
  • IDAK/CDAKB status of the LAR

On passing: a PNBP billing notice is generated. On failing: the application is returned with a list of deficiencies.

Step 6: PNBP Fee Payment​

The LAR pays the government registration fee through the designated payment system. Payment confirmation is entered in Regalkes, which unlocks the technical review queue.

Step 7: Technical Review​

Kemenkes evaluators assess the substance of the dossier. Expect at least one round of clarification queries (permintaan klarifikasi) issued through Regalkes. Respond promptly and completely — partial responses or delays restart the clock on that query round.

Step 8: NIE Issuance​

On successful completion of the technical review:

  • NIE number is generated and issued
  • The LAR receives the official NIE certificate from Kemenkes
  • The NIE number must be printed on all product packaging

Step 9: Post-Approval Label Update​

Before importing and distributing, update all product labeling to include the NIE number. Updated labels must match the approved label in the Regalkes system. Do not distribute product with old labels.