Indonesia Medical Device Registration: 20 FAQs on AKL, NIE, Fees and Halal Rules

Indonesia is Southeast Asia’s largest population market, with about 280 million people. It is the world’s fourth most populous country and its largest Muslim-majority country, and imports account for 80-90% of its medical devices. Its registration system, however, does not follow the European authorised representative model: the marketing authorisation belongs to the local certificate holder rather than simply attaching to the product. That fundamental principle shapes many of the commercial risks and practical details.

These 20 questions follow the pathway from the regulatory framework, classification and registration routes to certificate-holder risks, documentation, procedures, fees, timelines, halal certification, post-market duties and public procurement. They are based on current instruments including Permenkes No. 11/2025 and Permenkes No. 62/2017.

1. Regulatory framework (Q1-Q3)

Q1. Which authority regulates medical devices in Indonesia: BPOM or the Ministry of Health?

Not BPOM, the National Agency of Drug and Food Control. Medical devices and in vitro diagnostics (IVDs) are regulated by the Directorate General of Pharmaceuticals and Medical Devices (Ditjen Farmalkes) under the Ministry of Health (Kemenkes/MoH). Applications are handled through the Regalkes online system at regalkes.kemenkes.go.id.

BPOM regulates medicines, health supplements, cosmetics, processed foods and similar products. It coordinates on IVDs only in certain scenarios. Halal certification falls under BPJPH, the Halal Product Assurance Organising Agency within the Ministry of Religious Affairs.

Companies sometimes mistakenly place devices within the BPOM system and start preparing the wrong materials. Confirm the competent authority and pathway at the outset.

Q2. What do AKL, AKD and NIE mean?

These three abbreviations are central to Indonesian registration and must not be confused:

• NIE (Nomor Izin Edar) is the marketing authorisation number issued by the Ministry of Health. Every device must obtain it before importation or sale in Indonesia.
• AKL is the NIE code prefix for imported devices, from Alat Kesehatan Luar Negeri, meaning foreign medical devices.
• AKD is the NIE code prefix for devices manufactured in Indonesia, from Alat Kesehatan Dalam Negeri, meaning domestic medical devices.

Products from Chinese manufacturers follow the AKL route. AKL and AKD undergo broadly the same review process, but imported devices require the manufacturer’s ISO 13485 certificate and Certificate of Free Sale (CFS), while domestic devices require the local production licence known as CPAKB. Only the imported route requires a Letter of Authorisation (LoA).

Q3. Which regulations currently apply, and are the older rules still valid?

The foundational regulation and the newer framework must be read together:

In practice, use Permenkes No. 62/2017 for the substantive registration requirements and Permenkes No. 11/2025 for review timelines and the licensing framework. Because system updates may lag, the timelines displayed on Regalkes may not yet reflect the new rules.

2. Risk classification and registration pathway (Q4-Q5)

Q4. How many risk classes does Indonesia use, and which products fall into each class?

Indonesia uses four classes aligned with the ASEAN Medical Device Directive (AMDD):

IVDs also use Classes A-D, but dedicated classification rules apply to diagnostic reagents.

Q5. If a device is Class II in China, is it automatically Class B in Indonesia?

No. Directly mapping another jurisdiction’s class onto Indonesia is one of the most common mistakes. Indonesian criteria do not exactly match those of China’s NMPA, the EU MDR or the US FDA. Classification depends on factors including intended use, duration of contact, degree of invasiveness, and whether the device contains medicinal or biological-origin materials.

For example, some products managed as Class II in China may be Class B or Class C in Indonesia, while similar IVD reagents may be classified more granularly. An incorrect class has two likely consequences: the dossier does not match the required depth and is returned, or the entire application must be reassessed, losing several months.

The correct approach is to make a formal determination under the Indonesian rules before preparing documents and retain the classification rationale in the project records.

3. Certificate holders and commercial risk (Q6-Q10)

Q6. Can a foreign manufacturer hold an Indonesian registration certificate itself?

No. This is a key difference from the European model. Indonesian law expressly prevents an overseas manufacturer from holding an NIE in its own name. The registration must be held by an Indonesian legal entity that holds both an IDAK distribution licence and CDAKB good distribution practice certification.

There are two lawful routes:

• Establish your own PT PMA, a foreign-investment company, and have that Indonesian entity hold the certificates. This gives the greatest control but requires the cost of establishing and maintaining an entity, office and personnel.
• Appoint an independent certificate holder or local authorised representative (LAR) to hold the NIE through a local company. This usually enables faster entry with less capital committed.

Critical point: under Article 13 of Permenkes No. 62/2017, a product trade name can have only one certificate holder at any given time.

Q7. What qualifications must the certificate holder or LAR have?

Not every Indonesian company can hold a device registration. The holder must meet all of the following requirements:

• Be a legal entity registered in Indonesia with a Business Identification Number (NIB) obtained through OSS.
• Hold an IDAK medical device distribution licence.
• Hold CDAKB good distribution practice certification, mandatory since July 2024. A holder without CDAKB cannot list products for sale on E-Katalog or participate in public hospital and government tenders. Non-compliance can even put the product registration at risk of cancellation. Manufacturers should verify CDAKB certification before appointing any consultant or authorised representative.
• Have physical office premises and compliant warehousing, normally with a lease of at least two years.
• Employ at least one qualified technical person in charge (PJT/Penanggung Jawab Teknis), normally with a background in pharmacy, biology, medicine, chemistry or a related field. The PJT must be an employee of the certificate holder.

The holder must also participate in importation and carry post-market surveillance, vigilance reporting and recall obligations. Legally, these responsibilities sit with the local holder rather than the foreign manufacturer.

Q8. What is the difference between IDAK and CDAKB, and why are both necessary?

Both are company-level qualifications, not product-level approvals, and both must be in place before any product registration:

• IDAK (Izin Distribusi Alat Kesehatan) is the medical device distribution licence. It establishes the legal qualification to operate: without it, a company cannot import or distribute devices or submit any product registration.
• CDAKB (Cara Distribusi Alat Kesehatan yang Baik) is good distribution practice certification. It is the quality-system qualification covering incoming inspection, storage conditions, safe transport, installation and commissioning, after-sales service and quality control throughout the distribution chain.

Under Permenkes No. 11/2025, CDAKB is firmly embedded in OSS. For a device distributor classified under KBLI 46691, the NIB cannot function in practice without CDAKB. The licence is a system-level gate, not a procedural step that can be bypassed.

CDAKB is also subject to periodic on-site audits. A failed audit can lead to suspension, and once CDAKB is suspended, the NIEs linked to it are frozen as well.

Q9. What are the risks of appointing a distributor as the certificate holder?

Indonesia operates an exclusive-holder model: the same brand, product and manufacturer can have only one certificate holder. Appointing a distributor is a long-standing practice among exporters, but it creates structural commercial risks:

• Loss of control: the distributor holds the registration, import authorisation and customer relationships, leaving the manufacturer without practical control over its route to market.
• Locked channels: when the manufacturer wants to appoint a second distributor, the original distributor may claim exclusivity across the product category and block new channels.
• Compressed margins: under the E-Katalog central procurement price structure, importer mark-ups across the national channel can squeeze the manufacturer’s pricing flexibility and profit.
• Difficult transfer: if the relationship deteriorates, moving the certificates depends entirely on cooperation from the original holder.

The widely preferred approach is an independent holder that handles registration and importation only, without participating in sales, distribution or commercial negotiations. The manufacturer remains free to appoint multiple distributors and can later transition smoothly to its own PT PMA.

Q10. Does changing the certificate holder require a new registration?

Yes, and the cost is significant. Indonesian registrations cannot be transferred directly. Moving a product from one representative to another requires cancellation of the original certificate followed by a fresh application by the new representative, with the full AKL registration timeline starting again.

The greater danger is a stalled transfer. If the original holder refuses to cooperate or return the LoA, Ministry of Health rules impose a six-month waiting period before the manufacturer can reapply. During that period, the Ministry contacts the distributor. If the cancellation is disputed, a further six months may be added for the parties to resolve the matter internally.

The contract should therefore define the LoA’s scope and term, the obligation to cooperate in transferring certificates on termination, and remedies for breach. These provisions can matter more than the pricing clause.

4. Documentation, procedures, timelines and fees (Q11-Q17)

Q11. Which technical documents are required for registration?

Indonesia uses the ASEAN Common Submission Dossier Template (CSDT). The core materials include:

• Administrative documents: Letter of Authorisation (LoA), Certificate of Free Sale (CFS), ISO 13485 certificate, manufacturer qualifications and declaration of conformity.
• Technical documents: device description and intended use, risk management report under ISO 14971, manufacturing information and production processes, and verification and validation data. Depending on the device, this includes electrical safety under IEC 60601, biocompatibility under ISO 10993, sterilisation validation, and IEC 62304 and cybersecurity documentation for software.
• Clinical documents: Classes C and D require a Clinical Evaluation Report (CER), and Class D generally requires more comprehensive clinical data.
• Labelling documents: labels and instructions for use (IFU) in Bahasa Indonesia.

Even where CE marking or FDA approval already exists, Indonesia still requires a complete local dossier. Those approvals are strong supporting evidence and may reduce deficiency rounds, but they do not create an abridged route that can simply be invoked.

Q12. Which LoA and CFS requirements are commonly overlooked?

These two administrative documents are frequent sources of avoidable dossier problems:

• LoA: the manufacturer must issue the Letter of Authorisation. It must be legalised by the Indonesian embassy or consulate in the manufacturer’s country (KBRI) or authenticated with a Hague Apostille. Its term must cover the five-year registration cycle; in practice, a term of at least two years is required.
• CFS: the Certificate of Free Sale must demonstrate lawful marketing in the country of origin and likewise requires notarisation and consular legalisation or an apostille.
• Consistency: the manufacturer’s name and address must be exactly identical on the ISO 13485 certificate and CFS. Even an abbreviation difference such as Street versus St. can cause the application to be returned.

Consular legalisation and apostille processing commonly take two to six months, depending on the country of origin. Build this lead time into the overall project schedule.

Q13. Can labels and instructions for use be in English?

No. Bahasa Indonesia is mandatory and must be the principal language. Under Permenkes No. 1190/Menkes/Per/VIII/2010:

• Labels and IFUs must be in Bahasa Indonesia, using translations that follow local usage. Control panels for active equipment must also have Bahasa Indonesia instructions.
• Mandatory information includes the product name or trademark, model and specifications, batch number, registration number (NIE), manufacturer and authorised representative details, expiry date, storage conditions, import licence number and necessary safety markings.
• Under Permenkes No. 11/2025, devices for professional use may also use electronic instructions (e-labelling) or a QR code.

Labels actually placed on the market must exactly match the version submitted for review. The Ministry of Health checks compliance through market sampling, including purchasing products from shelves and inspecting hospital warehouses. Label mismatches are a common enforcement issue.

Q14. What are the steps in the registration process?

The complete process is as follows:

1. Step 1: Confirm the product risk class (A-D) and registration pathway.
2. Step 2: Appoint the certificate holder, verify that its IDAK, CDAKB and NIB are in place, and open its Regalkes account.
3. Step 3: Prepare the CSDT dossier, including Bahasa Indonesia labelling.
4. Step 4: Submit online through Regalkes. The system automatically checks the company’s IDAK and CDAKB status.
5. Step 5: Pay the PNBP government fee. Payment must be made within seven days after the invoice is generated; an overdue invoice becomes invalid and the application must be resubmitted.
6. Step 6: Undergo administrative review for document completeness, followed by technical review of safety, effectiveness, performance, labelling and risk management.
7. Step 7: Respond to deficiency requests, normally within 10-15 working days, or the application may be rejected.
8. Step 8: After approval, receive the NIE with an AKL number. Only then may the product be legally imported and sold.

Permenkes No. 11/2025 allows two deficiency-response rounds, each lasting no more than 10 working days, or 15 working days for Class D.

Q15. How long does registration take, and have the new rules changed the timeline?

Permenkes No. 11/2025 has generally extended official review times. All periods in the table are working days:

The official review period is only the regulatory clock; total end-to-end timing is longer. Holder qualifications and the dossier must be ready before that clock starts, and deficiency rounds pause it. Practical end-to-end estimates are about one month for Class A, one to two months for Classes B and C, and one to three months for Class D.

Manufacturers should treat the decision to enter Indonesia as the start of registration, rather than waiting until they are ready to sell.

Q16. What are the official PNBP fees?

Government fees are charged per product according to risk class. The following reference amounts are in Indonesian rupiah:

The PNBP fee for an IDAK distribution licence is approximately IDR 1,000,000, or about USD 60-70. These figures cover government charges only. They exclude certificate-holder service fees, registration agent fees, laboratory testing, translation and notarisation, clinical evaluation and other project costs.

Official fees are fixed standard tariffs but may be adjusted. Use the actual invoice generated by Regalkes at the time of submission.

Q17. How long is a registration valid, and what happens at expiry?

The usual validity period is five years under Article 24 of Permenkes No. 62/2017. If the LoA has a shorter term, the shorter period prevails.

Key renewal points:

• File for renewal before expiry. Industry practice is to start at least 60 days in advance rather than waiting until the deadline.
• A previous disruption illustrates the risk: Regalkes was shut down for an upgrade from 15 December 2025 to 9 January 2026, and NIEs expiring during that period were treated as invalid from 1 January 2026. A system outage is not an exemption from renewal obligations.
• Renewal can be combined with a variation application, and the combined filing attracts a lower government fee.

5. Halal certification, post-market duties and public procurement (Q18-Q20)

Q18. Is halal certification mandatory, even for devices without animal-derived ingredients?

This is the most urgent new compliance issue for 2026. PP No. 42/2024 has brought medical devices into the mandatory halal system. BPJPH issues the certificates, and the obligation is phased in by risk class:

Devices containing animal-derived ingredients or biological materials must obtain halal certification. Devices without animal-derived ingredients may currently be exempt, but any device containing a non-halal ingredient must be clearly labelled as non-halal.

The main procedural and commercial points are:

• Applications are submitted through the SIHALAL portal. An authorised halal inspection body (LPH) audits the production process, MUI issues the religious ruling, and BPJPH issues the certificate. A halal certificate is valid for four years.
• If a foreign halal body in the country of origin has a mutual recognition agreement (MRA) with BPJPH, its certificate can use the SHLN foreign halal certificate registration route. The best-case timeline is about 30 working days, avoiding the need for an LPH team to travel to the Chinese factory for an on-site audit.
• For animal-derived devices that cannot technically be substituted, such as porcine collagen dressings, a statement that certification is not possible may be requested. A prominent red label in Bahasa Indonesia identifying the porcine content is required, and the product will be disadvantaged in public hospital tenders that prioritise halal products.
• Since 2026, AKL applications have required a linked halal certificate number or a statement that certification is not possible. The two processes are now closely interlocked.

Routine halal certification, including the on-site audit and raw-material traceability review, usually takes six to nine months. The remaining window for Class A products is therefore already very tight.

Q19. What continuing obligations apply after the certificate is issued?

Registration approval is only the beginning. The certificate holder must continuously fulfil the following duties:

• Semiannual distribution reports: submit every six months through Regalkes, including product names, batch numbers and expiry dates.
• KFA code registration: every NIE holder must register in the pharmaceutical and medical device dictionary (KFA) system and obtain the standard product code.
• Vigilance reporting: promptly report serious adverse events, device malfunctions and near-miss incidents to the Ministry of Health.
• Periodic CDAKB audits: failure can suspend CDAKB and consequently freeze the associated NIEs.
• Material change reporting: changes to design, labelling, the manufacturer and other regulated details must go through the variation process.

The legal responsibility for these duties rests with the local certificate holder, not the foreign manufacturer. This is why selecting the right holder matters even more than selecting the right distributor.

Q20. What additional requirements apply to public hospitals and government procurement through E-Katalog?

A registration certificate is only an entry ticket. Listing in the government procurement catalogue adds further requirements:

• KFA code: since 1 January 2025, E-Katalog Version 6 has required a matching KFA code. Without one, a product cannot enter the catalogue and is excluded from public hospital procurement.
• Prerequisite qualifications: the NIE, IDAK and CDAKB must all be in place. A notarised LoA, CFS and ISO 13485 certificate are also normally required.
• TKDN local content: government procurement applies a local-content threshold, commonly cited as 40%. Since 2022, thousands of imported device models have been excluded from E-Katalog for failing to meet it. Local content, assembly, service and supply-chain commitments increasingly affect competitive outcomes.
• Halal compliance advantage: products with a valid BPJPH halal certificate can receive additional weight in tender scoring. Conversely, an uncertified product can be downgraded or even excluded where a halal alternative with the same efficacy is available.
• After-sales capability: imaging, IVD, surgical, ICU and dental equipment requires installation, calibration, maintenance, spare parts and clinical application support.

Obtaining an AKL does not guarantee public-sector orders. Success in government procurement depends on price, continuity of supply, catalogue access, local content and local service.

This article was compiled from publicly available regulatory materials current as of its publication date, including Permenkes No. 62/2017, Permenkes No. 11/2025, UU No. 17/2023, PP No. 28/2025, PP No. 42/2024 and relevant BPJPH provisions. Indonesian regulations continue to evolve. For each project, confirm classification, timelines, fees and compliance requirements against the latest regulations and the official systems’ actual requirements. This article does not constitute legal or compliance advice.