Food, Cosmetics, Medical & Halal

Medical Device Registration (AKL / AKD)

Assess applicant, product, technical documentation, registration and import dependencies for Medical Device Registration (AKL / AKD).

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Overview

Start with applicability and dependencies.

Assess applicant, product, technical documentation, registration and import dependencies for Medical Device Registration (AKL / AKD). The final route should be based on the project facts and current authority requirements rather than a generic checklist.

Who this is for

Foreign companies evaluating or entering Indonesia
Existing Indonesian entities with an operational or compliance requirement
Businesses in Healthcare & medical devices
Regional legal, tax, product or project teams coordinating Indonesian workstreams

Regulatory note: Information is current as of 31 August 2026. Final applicability, timing and approval outcomes require project-specific review.

What we help with

A structured workstream

Applicant / holder readiness

Confirm who will apply, hold the approval, import or distribute.

Product scope

Define products, models, variants, factories, claims and intended use.

Technical documentation

Review labels, specifications, certificates, test data and authorisations.

Testing & submission

Coordinate applicable testing, certification or registration activities.

Import & maintenance

Connect approval to importing, launch, changes, renewals and ongoing compliance.

Possible deliverables

Define what completion means before work begins.

Applicability and dependency summary
Defined document / information request list
Agreed submission or delivery tracker
Outcome records and outstanding-action list
Related-service and ongoing-compliance roadmap

The final deliverable list is confirmed in the written scope and may vary by application, product, site, entity or project stage.

How it works

From assessment to completion

Applicant / holder readiness

Confirm who will apply, hold the approval, import or distribute.

Product scope

Define products, models, variants, factories, claims and intended use.

Technical documentation

Review labels, specifications, certificates, test data and authorisations.

Testing & submission

Coordinate applicable testing, certification or registration activities.

Import & maintenance

Connect approval to importing, launch, changes, renewals and ongoing compliance.

What we need

Useful information for an initial review

Description of the activity or requirement
Existing company, product, site or licence documents
Ownership, applicant or responsible-party information
Target timing and commercial launch constraints
Known authority correspondence or previous consultant checklist

Clear scope

Professional fees, authority charges and third-party costs are separated.

Unless expressly included, the scope does not automatically include unrelated entity setup, product testing, engineering, construction, freight, customs brokerage, legalisation, translation, authority charges or third-party professional fees.

Request a Defined Scope

FAQ

Questions about this service

Is Medical Device Registration (AKL / AKD) always required?

Applicability depends on the actual activity, structure, product, location, capacity and current authority requirements. We confirm scope before engagement.

Can you quote before reviewing documents?

We can usually provide an initial scope, but final fees, timing and third-party costs may depend on document readiness and the number of applications, products, sites or entities involved.

Are government and third-party fees included?

Only when the written quotation says so. Professional fees, government charges, testing, notary, engineer, auditor, translator and other third-party costs should be separated clearly.

Can this be part of a larger Indonesia entry project?

Yes. The service can be connected to corporate setup, tax, immigration, imports, product approvals, factory or ongoing compliance workstreams.

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Start with the facts

Planning a project involving Medical Device Registration (AKL / AKD)?

Send the current structure, documents and target timing. We will help define the next steps.

Send Us Your Device List