What Registration Is Required to Export Medical Devices to Indonesia? | Ameli

Direct answer: Exporting medical devices to Indonesia requires an AKD import registration submitted to the Indonesian Ministry of Health (Kemenkes) by an Indonesian licensed entity. The device must first be classified by risk (Class A–D), followed by submission of technical documentation, quality system evidence, proof of approval in the country of origin, and Indonesian-language labels and instructions for use. Import and sale may proceed only after AKD is granted; the license is typically valid for 5 years and must be renewed upon expiry.

Key Requirements

• Competent authority: Indonesian Ministry of Health (Kemenkes) — https://kemkes.go.id/
• License type: AKD (imported medical device registration) / AKL (local manufacturing)
• Classification: Class A (low risk) to Class D (high risk)
• Local requirement: The application must be submitted by an Indonesian licensed entity (importer or authorized representative).
• Core documents: (1) classification basis; (2) technical file; (3) ISO 13485 evidence; (4) proof of approval in the country of origin; (5) Indonesian-language labels and instructions for use.
• Validity: Typically 5 years; renewal is required.

Professional Notes

The Indonesian Ministry of Health (Kemenkes) regulates medical devices in Indonesia. Imported products require an AKD import registration license. The official Kemenkes website is https://kemkes.go.id/. Verification date: 2026-11-02. Prepared by the Ameli Regulatory Editorial Team based on public pages of the target country's regulatory authority.

Frequently Asked Questions

Does Class A also require registration?

Yes. Low-risk devices still require a license; however, the documentation and review requirements differ.

What should be done when the registration certificate expires?

Renewal must be completed before the expiry date. After expiry, continued import and sale are not permitted.

Sources: Official website and regulatory pages of Kemenkes cited above; verification date: 2026-11-02. This article is a summary of regulatory information and does not constitute legal advice. Specific requirements are subject to the latest requirements of the competent authority. Ameli is a platform for medical device companies' overseas registration; it is not a CRO and not an agent.