EU Authorized Representative for Indonesia: AKL, AKD and Who Holds What in Europe
In Indonesia the marketing authorisation for an imported device belongs to a local sole agent, and the AKL or AKD prefix on the izin edar number tells everyone where the product was made. Manufacturers who have worked inside that structure for years tend to assume Europe runs on the same logic, with a distributor holding the approval. It does not, and the misunderstanding is expensive. Alongside it sits a domestic-content policy that has rewarded Indonesian firms for pointing their regulatory effort inward, at the e-catalogue rather than at Annex VIII.
Two letters that settle everything in Jakarta
Indonesian device regulation turns on the izin edar, the marketing authorisation issued by the Ministry of Health through its online registration system. The number it produces begins with a code, and the code carries the whole story: AKL for an imported device, AKD for one made in Indonesia. A hospital procurement officer reads the prefix before reading the product name.
The Ministry's own bilingual guidance grades devices as Class A low risk, Class B low to medium, Class C medium to high and Class D high, and presents them alongside the older European labels I, IIa, IIb and III. That presentation is where the trouble starts for exporters. It maps Indonesian classes onto a European scheme that has since been replaced by Regulation (EU) 2017/745, which does not assign classes at all: the manufacturer derives them by applying the rules in Annex VIII to intended purpose, invasiveness and duration of contact. An Indonesian Class B is not a European class IIa because a table once put them in the same row.
A registration your partner owns, and a CE mark that cannot work that way
For an imported device the izin edar is held by an Indonesian legal entity — a sole agent or sole distributor — acting under a power of attorney from the principal, notarised for domestic products and legalised through the Indonesian embassy for foreign ones. The registration belongs to the local partner, not to the factory that made the device. That is a perfectly coherent design, and Indonesian manufacturers who have spent years on the receiving end of it naturally assume Europe mirrors it: find a good European distributor, let it hold the approval.
It does not work that way. The Regulation attaches obligations to the manufacturer and keeps them there:
"Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative." (MDR Art. 11(1))
The representative is a mandated agent, not a holder of your rights, and the mandate cannot go to just anyone:
"‘authorised representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation;" (MDR Art. 2(32))
Your European buyer may well also be your importer, and may even accept the mandate if it is established in the Union and willing to take on the Article 11 tasks. What it cannot do is hold the CE mark in place of you, sign the declaration of conformity, or own the technical documentation. If it puts its own name on the product instead, it becomes the manufacturer and your company becomes a supplier — a different commercial arrangement entirely, and one to enter deliberately rather than by drift.
Indonesian commercial roles against MDR economic operators
| Role in the Indonesian system | What it does at home | Nearest MDR economic operator | What it cannot do |
|---|---|---|---|
| Sole agent holding an AKL izin edar | Holds the marketing authorisation for an imported device | Distributor under Article 14, or importer under Article 13 if it brings devices into the Union | Hold a CE mark or sign an EU declaration of conformity |
| Indonesian factory with an AKD and a production certificate | Manufactures and registers domestically | Manufacturer under Article 10, where the device carries its name or trademark | Act as its own representative, which must be established within the Union |
| European buyer that resells under your brand | Not applicable | Distributor, and importer if it is the first to place the device on the Union market | Substitute its registration for your designation of a representative |
| European buyer that relabels under its own brand | Not applicable | Manufacturer, with all the obligations that follow | Rely on your Indonesian file without taking responsibility for it |
| EU Authorized Representative | Not applicable | Article 11 | Design, manufacture, certify, or repair a technical file that is not there |
TKDN and an incentive structure that points inward
The domestic component level, TKDN, measures the Indonesian content of a product and drives access to public procurement. The Ministry of Health has been explicit about the direction of travel: e-catalogue spending on domestically produced medical devices rose from 12 per cent in the 2019 to 2021 period to 48.2 per cent by July 2023, and as at 30 June 2023 some 6,782 catalogue products, 24.9 per cent, held TKDN certificates above 50 per cent. Procurement priority is set by TKDN band under LKPP Head Decree No. 122 of 2022, and Minister of Health Decree HK.01.07/MENKES/1258/2022 requires substitution of imported devices where a qualified domestic alternative exists.
For an Indonesian manufacturer this has been a rational place to spend regulatory effort, and it has produced companies with strong domestic files and no European ones. It is worth being blunt about the transfer value: a TKDN percentage is invisible to a notified body, and a production certificate obtained to support an AKD registration is evidence about your factory, not a conformity assessment under Article 52. The domestic strategy and the export strategy do not share a document set.
Where Indonesian export lines meet Annex VIII
Indonesian manufacturers reach Europe mostly through consumables and equipment rather than through implantables or high-risk diagnostics, and the classification consequences are specific:
- An examination glove is a non-invasive device and sits in class I; the same glove supplied sterile becomes class Is, and Article 52(7)(a) brings a notified body in for the sterility aspects alone.
- Infusion sets, catheters and similar fluid-path products are caught by the invasive and channelling rules rather than by the non-invasive default, and routinely land above class I.
- Hospital beds, furniture and non-active supports generally stay in class I, where the burden is documentation and registration rather than certification.
- Wound care and dressing lines are classified by Rule 4 on the strength of the intended purpose wording, so a healing claim written for the Indonesian catalogue can raise the class in Europe.
- Any device with a measuring function joins the sterile and reusable categories in drawing a notified body into an otherwise class I route.
Running the mandate from Jakarta or Surabaya
Once the manufacturer question is settled the sequence is straightforward. The designation is agreed and accepted in writing and is effective for at least all devices of the same generic device group. The representative obtains a single registration number and registers the actors and the devices in EUDAMED, keeps the technical documentation and declaration of conformity available to competent authorities, answers their requests in the official Union language they specify, and cooperates on corrective action. Medex acts under EUDAMED authorised representative SRN TR-AR-000057550, keeps a person responsible for regulatory compliance in-house with a deputy, and operates from Ankara, Istanbul and Gdańsk. Annual fees are class-based and start at EUR 1000; the published schedule is on pricing, and the scope of the mandate is set out on the EU Authorized Representative page.
Misunderstandings we correct for Indonesian device companies
We hold an AKD and a production certificate. Does that help in Europe?
As background, yes; as conformity evidence, no. Both documents show that the Ministry of Health has satisfied itself about your facility and your product for the Indonesian market. Neither contains a finding against the general safety and performance requirements in Annex I, and neither produces anything a notified body can build on.
Our European buyer wants to register the device in its own name. What happens to us?
If the device then carries only the buyer's name and trademark, the buyer becomes the manufacturer under Article 10 and you become its supplier. That may be a good commercial outcome, but it changes who owns the design evidence, who answers a competent authority, and who can sell the same product to a second European customer. Decide it in the contract, not by default.
Our device is Class A in Indonesia. Is it class I under the MDR?
Sometimes, and never automatically. European class is derived from the Annex VIII rules applied to your stated intended purpose, not read from a mapping table. Sterile presentation, a measuring function, contact with injured skin and any fluid path are the usual reasons an Indonesian Class A product turns out to sit higher.
Does our TKDN certificate mean anything to a notified body?
No. It measures domestic content for Indonesian procurement purposes and has no counterpart in the Regulation. Keep it for the home market and build the European file separately. Send us your AKD or AKL numbers and a product list and we will map the portfolio against Annex VIII before you commit to anything.