AKL, AKD and Izin Edar: Indonesia Marketing Authorisation Explained

1. Key takeaways

The Indonesian market authorisation terminology is easy to confuse but the relationships are simple once stated plainly. Understanding how Izin Edar, NIE, AKL and AKD relate to each other, and how the validity rules interact with the licence holder’s own authorisations, prevents the most common non-technical causes of a licence lapsing unexpectedly.

• Izin Edar is the marketing authorisation certificate itself. NIE (Nomor Izin Edar) is the number of that certificate. AKL and AKD are prefixes of the number indicating the product origin: AKL stands for Alat Kesehatan Luar Negeri, meaning imported devices, and AKD stands for Alat Kesehatan Dalam Negeri, meaning locally produced devices.
• So when people say that a product has obtained its AKL, the actual meaning is that the marketing authorisation number for an imported device has been obtained.
• The licence holder is an Indonesian local entity in both cases, but the compliance evidence for the manufacturing side differs. Imported devices are supported by the foreign manufacturer’s ISO 13485 certificate, while locally produced devices are supported by the manufacturer’s CPAKB/CPB (good manufacturing practice) certificate; a free sale certificate from the country of origin is not applicable to the domestic manufacturing evidence.
• Imported devices additionally require an SKI to be processed batch by batch at the import stage.
• Validity: the marketing authorisation is valid for up to 5 years. If the licence holder is an authorised registered distributor, the certificate validity follows the term of the authorisation (LoA), and that authorisation term itself must be between 2 and 5 years. If the authorisation states no term or exceeds 5 years, the certificate is counted as 5 years. For products manufactured under the OEM model, the marketing authorisation validity does not exceed 3 years.
• A certificate can become invalid through: expiry of the certificate, expiry of the manufacturing licence, expiry of the IDAK distribution licence, expiry or non-renewal of the letter of authorisation, or revocation of the certificate. The expiry of the LoA invalidating the certificate is the provision most often overlooked by manufacturers, because the certificate can lapse while still within its own validity period the moment the LoA has a gap.

2. Legal basis

The validity and invalidation framework traces to Articles 24 and 25 of Permenkes No. 62/2017, which set out the validity period and the circumstances of invalidation; that instrument has since been superseded by Permenkes 5/2026, with the substantive rules carried over into Articles 50-51 of the new regulation, and the new text governs where the two differ. The numbering conventions for AKL and AKD are set out in the Kemenkes technical guidelines on medical devices (2016). For imported devices specifically, the service standards, required documents and time limits are found in Appendix 3 of Permenkes No. 11/2025. Taken together, these instruments define who may hold the certificate, what evidence supports an imported as opposed to a locally manufactured product, how long the certificate lasts, and the exact events that terminate it, including the interaction between the certificate term and the term of the underlying letter of authorisation from the manufacturer.

3. Expert insights

The interaction between the certificate term and the LoA term is the trap. A certificate can be perfectly valid on its face and still die the day the letter of authorisation expires or is not renewed, and because the certificate is the asset, every downstream element, from import rights to tender eligibility, dies with it. The same cascading logic applies to the IDAK distribution licence held by the licence holder: if that lapses, the certificates it holds are affected. The practical defence is a consolidated register of the four expiry dates that govern any certificate: the LoA expiry date, the IDAK expiry date, the CDAKB validity period and the Izin Edar expiry date. In practice, the most common non-technical loss of a certificate comes from misalignment among exactly these four dates, not from any technical deficiency in the dossier, which is why the register and its early warning routine matter more than most compliance manuals. A further subtlety is that the prefix system means the certificate itself advertises the product origin: anyone reading an NIE can tell immediately whether the product is imported or locally produced, which makes the prefix a useful first check when screening a partner’s certificate portfolio, before any deeper verification of validity status or product coverage is undertaken.

4. Practical recommendations

• Build a four-expiry register for every certificate covering the LoA expiry date, the IDAK expiry date, the CDAKB validity period and the Izin Edar expiry date, and set an early warning 9 months ahead of any of the four dates.
• When negotiating a letter of authorisation, set the term explicitly between 2 and 5 years and align it with the certificate term, avoiding an authorisation with no stated term or a term exceeding 5 years.
• For OEM-manufactured products, plan around the shorter validity, since the marketing authorisation validity does not exceed 3 years.
• Confirm with the licence holder which manufacturing evidence applies to each product: an ISO 13485 certificate for imported devices, or CPAKB/CPB certification for locally produced devices.
• Budget the batch-by-batch SKI process into the import plan for imported devices, since it is a recurring step at the import stage rather than a one-time filing.
• Review any appointment or distribution agreement for the cascade risk: because an expired or unrenewed LoA terminates the certificate, the agreement should place a clear renewal obligation on the party controlling the LoA and define what happens to the certificate if the commercial relationship ends.
• Check the current text of Permenkes 5/2026 Articles 50-51 before relying on any validity rule, since the historical provisions of Permenkes 62/2017 have been carried into the new instrument and the new text governs.

5. Verification checklist

• □ Permenkes No. 62/2017, Articles 24 and 25 (validity and invalidation circumstances; superseded by Permenkes 5/2026, with the new text governing).
• □ Permenkes No. 5/2026, Articles 50-51.
• □ Kemenkes technical guidelines on medical devices (2016), AKL/AKD numbering rules.
• □ Permenkes No. 11/2025, Appendix 3 (imported device standards).

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across Southeast Asia, including Indonesia. Our team prepares dossiers to ASEAN CSDT structure, manages AKL/AKL-I submissions with Kemenkes, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com