Importing Dental Equipment into Indonesia: AKL Licence, Distributor Licensing and Customs Guide

Indonesia has one of the largest and least-served dental markets in Asia. The Ministry of Health counted about 54,000 dentists in 2025 for a population of more than 280 million, and estimates a shortfall of roughly 10,000; some 2,700 public health centres still had no dentist in late 2025. Thirty-two dental faculties graduate around 2,650 dentists a year, and most of them open or join private clinics in the cities of Java, Sumatra and Bali. The great majority of the chairs and equipment in those clinics are imported, much of it from China.

Indonesia also rewrote its medical-device rules in 2025 and 2026. A new government regulation on risk-based licensing took effect in June 2025, and in May 2026 a single Ministry of Health regulation on health supplies replaced 37 older ones, including the 2017 regulation that dealers had worked with for years. The core of the system — an AKL marketing licence held by a licensed Indonesian distributor — has not changed. This guide sets out the steps in order.

Businesses have until May 2027 to align with the 2026 regulation, and technical guidance is still being issued. Treat this as a planning framework and confirm the current requirements with your licensed distributor and your customs broker before you commit to a shipment.

The legal framework in 2026

• Health Law No. 17 of 2023 and its implementing Government Regulation No. 28 of 2024 set the basic rule: medical devices may only be circulated with a marketing licence (izin edar) from the Ministry of Health (Kemenkes).
• Government Regulation No. 28 of 2025 on risk-based business licensing (in force June 2025) holds the licensing details — the documents, the service times in working days and the validity of the licences.
• Minister of Health Regulation No. 5 of 2026 on health supplies (in force 4 May 2026) replaced Permenkes 62/2017 on marketing licences, Permenkes 60/2017 on import control and the 2010 distribution regulations, among others. Businesses have a year, to May 2027, to comply.

Applications start in the national OSS licensing system and are assessed on the ministry's regalkes portal.

How Indonesia classes dental equipment

Devices are classed A (lowest risk) to D on the ASEAN Medical Device Directive model (Permenkes 5/2026, Article 55). Indonesia has not published a dental-specific list, and the classification is confirmed when your distributor files, but the ASEAN rules point to the following:

Device	Likely class	Note
Dental patient chair	A or B	B once it is a powered unit with instruments
Dental treatment unit with handpieces and suction	B	Powered handpieces and suction are typically B
Dental air compressor, suction unit	B	Confirm on filing
Intraoral camera	A or B	Depends on the claimed function
Steam steriliser (autoclave)	Possibly C	The ASEAN harmonised list puts end-point sterilisers in Class C

Class matters for timing and for halal (below). If a steriliser is filed as Class C, it needs a fuller file than the chair it ships with.

The AKL licence and the distributor

An imported device receives an AKL (Alat Kesehatan Luar negeri) marketing licence number. A foreign factory cannot apply. The applicant is an Indonesian company holding a medical device distribution licence — known in the trade as IDAK, formerly IPAK — with a certificate of good distribution practice for medical devices (CDAKB), appointed by the manufacturer. A manufacturer can also set up its own foreign-owned (PT PMA) distribution company, but most work through a distributor.

• The letter of appointment (LoA) is the core document. It names the distributor and the products and may run for up to five years; the licensing annex still says it is legalised by the Indonesian mission in the country of origin. Indonesia joined the Hague Apostille Convention in June 2022 and China in November 2023, so an apostille is now the standard form of legalisation between them — confirm with your distributor which form the portal currently accepts.
• Validity. An AKL is valid for up to five years and never longer than the letter of appointment behind it. If the appointment ends, so does the distributor's right to the licence — which is why an Indonesian partnership and its regulatory set-up are planned together.
• Service time. Government Regulation 28/2025 sets the official review time for a new import licence at 21 working days for Class A, 36 for Classes B and C, and 55 for Class D, counted from a complete file. Correction rounds add to that; three to six months from starting the file is a realistic plan for a first range.

What your factory must provide

• The letter of appointment, signed and legalised or apostilled.
• A Certificate of Free Sale from the competent authority in China.
• ISO 13485 certification of the factory and the CE certificate and declaration of conformity for the dental units, covering the exact model numbers.
• The technical file: device description, specifications, electrical-safety and EMC test reports to IEC 60601-1 and 60601-1-2 (adopted in Indonesia as SNI IEC standards), risk management, and the labels and instructions for use.
• For Class C devices such as a steriliser, the additional clinical and performance evidence the class requires.

Labelling in Bahasa Indonesia

Indonesia has long required the intended use, directions for use, contraindications and warnings of a medical device to be given in Bahasa Indonesia, and the Language Law requires product information in Indonesian. In practice the distributor prepares an Indonesian label and instructions, which are submitted with the AKL file; English technical manuals can accompany them. Agree the text before the factory prints labels.

Halal: what applies to dental equipment

Indonesia's halal law is being phased in for medical devices: Class A from 17 October 2026, Class B from 2029, Class C from 2034 and Class D from 2039 (Government Regulation 42/2024). The obligation applies only to devices derived from or containing animal elements (Presidential Regulation 6/2023). A dental chair of metal and synthetic upholstery, a compressor or a steriliser is outside it; the point to check is genuine-leather upholstery or any animal-derived consumable, and your distributor confirms the position for each product before the date for its class.

Wi-Fi products: postel certification

A Wi-Fi intraoral camera, or a camera computer with built-in Wi-Fi or Bluetooth, also needs a telecommunications equipment certificate (sertifikat postel) under Minister of Communication and Informatics Regulation No. 3 of 2024, which covers any equipment with telecommunication features and has no medical-device exemption. The applicant is an Indonesian company with a business number — the brand owner's appointed distributor qualifies — filing through OSS; the certificate is issued per brand, type and country of origin, imports under it are allowed for three years, and the product carries a label with the certificate number and QR code. A USB camera with no radio does not need it.

Customs, Form E and VAT

• Importer. The importer's business identification number (NIB) serves as its importer number; a distributor reselling goods holds the general importer identity (API-U).
• Single window. Medical-device imports are declared through a system integrated with the INSW national single window and carry the AKL number (Permenkes 5/2026, Article 58), so the licence must be in place before the container sails. The AKL holder needs no separate Ministry of Health permit per shipment; another company importing under the holder's authority needs a one-shipment authorisation letter.
• New goods only. Indonesia's used-goods import rules allow only new goods, with narrow exceptions.
• Form E. Chinese-origin equipment qualifies for preferential duty under the ASEAN–China Free Trade Agreement when it travels with a Form E certificate of origin; Indonesia and China exchange Form E data electronically. We do not publish duty rates; your customs broker confirms the tariff line — 9402.10 for a dental chair, 9018.49 for a dental unit, 8414 for a compressor, 8419.20 for a steriliser — and the landed cost.
• VAT. Since January 2025 VAT is 12 percent applied to 11/12 of the import value for non-luxury goods, an effective 11 percent, recoverable by a VAT-registered importer.

Public procurement: where imports do not compete

Public hospitals and health centres buy through the government e-catalogue, and Presidential Regulation 46/2025 sets a mandatory order of preference for products with local content. The Ministry of Health can also freeze imported items in its catalogue once a domestic equivalent has a licence and capacity (Kepmenkes 1314/2023), and dental units were on the 2021 list of device types that government buyers were told not to import. In practice imported dental chairs sell to private clinics, dental chains and private hospitals — which is where most of Indonesia's new dental capacity is being built.

Ports, transit and power

Our factory is in Foshan, an hour from the container ports of Guangzhou (Nansha) and Shenzhen. Direct services reach Tanjung Priok in Jakarta in about 7–10 days port to port; Tanjung Perak in Surabaya and Belawan in Medan take a little longer. Priok itself has had episodes of severe truck congestion — up to twelve-hour waits in April 2025, and depot-related gridlock in May 2026 — so ask your broker about the current situation when you book. A single chair travels as LCL (shared container); a first order for resale is usually a 20 ft container, and the packing data we send with every quotation lists how many units fit in a 20 ft and a 40 ft box.

The mains supply is 230 V / 50 Hz with Type C and F sockets, so the standard 220 V / 50 Hz version of our chairs and compressors is the right one. Java's grid is stable; outside Java it is less so — a transmission failure on 22 May 2026 blacked out Sumatra from Aceh to Jambi, and parts of Aceh had rotating outages afterwards. Clinics there should size a UPS or generator for the compressor's starting current, which we provide on request.

After the sale

The AKL holder is responsible for post-market surveillance: it keeps procedures for complaints, adverse events and recalls, reports adverse events to the ministry through its e-Watch Alkes system, and files periodic reports. Permenkes 5/2026 requires a vigilance programme, with the detailed deadlines left to ministerial decision. In practice the distributor keeps serial-number records of every unit installed, spare parts in the country and a technician who can reach the clinic — on an archipelago, the hardest of the three.

What to ask your factory for — a supplier checklist

• A letter of appointment naming your company and the products, for up to five years, legalised or apostilled as your distributor's portal requires.
• Certificate of Free Sale from China; ISO 13485 certificate; CE certificate and declaration of conformity for the dental units, covering the exact model numbers.
• The technical file with IEC 60601-1 and 60601-1-2 test reports, and the likely class of each device.
• Labels and instructions ready for Bahasa Indonesia text, agreed before printing; the upholstery material stated, for the halal check.
• For Wi-Fi products: the radio test reports your postel applicant needs.
• Electrical specification — 220 V / 50 Hz, Type C / F plug — on the proforma invoice; starting-current data for compressors.
• Form E certificate of origin, commercial invoice and packing list matching the tariff lines agreed with your broker.
• A spare-parts kit and remote technical training with the first container.

Planning the timeline

1. A distributor that already holds the licences: sign the letter of appointment, legalise it, file the AKL — about two to four months for a Class B range with a complete file — then order and ship; Jakarta is only a week or so away by sea.
2. A new company: business registration (NIB), the medical device distribution licence and the good-distribution-practice certificate first, then as above.
3. Before May 2027: check with your consultant that procedures and licences are aligned with Permenkes 5/2026.

Working with VOTEN on Indonesian orders

VOTEN Medical manufactures dental chairs, dental units, compressors and clinic equipment in Foshan, China, and supplies clinics and dealers in Indonesia through an authorised distributor. For an Indonesian licence holder we provide the letter of appointment, the Certificate of Free Sale, the ISO 13485 and CE certificates for the dental units, the declaration of conformity, the technical file and test reports against the model numbers on your order, and the Form E certificate of origin; the chairs and compressors ship in the standard 220 V / 50 Hz version.

If you are planning a first order for Indonesia, send us your model list and your city and we will come back with the document pack, specifications, packing data and distributor pricing. Our Indonesia page covers the market, the electrical version and shipping in more detail; the equipment range is on our dental chair and products pages.

Sources: Permenkes No. 5 of 2026 on health supplies; Permenkes 5/2026, full text; Government Regulation No. 28 of 2025 on risk-based licensing; Permenkes No. 11 of 2025; Harmonised classification of medical devices in ASEAN (2025); HCCH, Apostille Convention status table; Government Regulation No. 42 of 2024 on halal assurance; Presidential Regulation No. 6 of 2023 (halal, medical devices); Permenkominfo No. 3 of 2024 on telecommunication equipment certification; Permendag No. 16 of 2025 on import policy; PMK 171/2020, ACFTA rules of origin; DJP, VAT under PMK 131/2024; Kepmenkes 1314/2023 on substituting imported devices; Kemenkes, dentists and dental services (2025); South China–Jakarta direct service schedule; Sumatra blackout, May 2026; Tanjung Priok congestion, April 2025.