Regulatory & Licensing Advisory

Medical Device Registration Indonesia

Planning to supply medical devices to Indonesia? MDM helps overseas manufacturers and Indonesian distributors organise product information, identify documentation gaps and coordinate registration work.

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Who needs this service?

This service supports manufacturers and distributors planning an Indonesian launch, adding products to a portfolio or reviewing an existing registration project. The starting point is the device’s intended purpose, model range and available technical evidence.

The Ministry of Health, known as Kemenkes, operates the Regalkes registration portal for medical devices and household-health products. This is a separate route from BPOM product registration.

Product and applicant readiness

Before scheduling a submission, clarify the intended use, manufacturer, model list and proposed Indonesian applicant. The Ministry’s evaluation guide distinguishes risk classes A–D and administrative and technical documentation. Read the Ministry’s evaluation guide (2020, PDF).

For an initial MDM assessment, tell us whether this is a new application, an existing product range or a change of commercial arrangements. Bring the current applicant permissions and appointment documents so that the local structure can be reviewed against the relevant route.

Documents to prepare

The Ministry’s evaluation guide covers items such as manufacturer authorisation, free-sale and quality-system evidence, product descriptions, labelling, instructions and safety/performance documentation. The evidence required varies with the device and risk class. Consult the administrative and technical checklists (PDF).

To organise the initial review, prepare:

  • A model list with intended use and a clear description of differences between variants.
  • An inventory of available manufacturer certificates and their expiry dates.
  • Current labels, packaging and instructions for use.
  • A list of technical reports already available and any documents still being prepared.
  • Details of the local applicant and the proposed manufacturer–distributor arrangement.

This is a preparation list, not a universal filing checklist. Current portal instructions and product-specific requirements must be checked for the proposed application.

How MDM supports registration

  1. Define the project. Review the device, intended market and proposed applicant.
  2. Map documentation gaps. Compare available material with the applicable submission needs.
  3. Coordinate preparation. Agree document owners, priorities and a working schedule with the manufacturer and local team.
  4. Support application follow-up. Track requests and coordinate responses within the agreed scope.
  5. Connect registration to operations. Plan related import and compliance work with the relevant parties.

Product licensing involves authority evaluation of administrative and technical requirements. MDM cannot guarantee approval. Ministry evaluation guidance (PDF).

Timeline planning

Separate preparation time from authority-review time. A project with missing manufacturer documents needs a different schedule from a submission-ready dossier. Product complexity, document revisions and follow-up requests must be considered before agreeing a launch target.

We can scope the work after reviewing your product and available documents. The 2020 guide is a technical reference; current Regalkes announcements and instructions should be checked before filing, rather than treating an older published schedule as a delivery guarantee.

Issues to resolve before submission

  • Inconsistent model names across labels, certificates and technical documents.
  • Unclear responsibilities between the manufacturer and proposed local applicant.
  • A product description that does not match the intended use in the supporting evidence.
  • Missing reports or expiring documents discovered after the project schedule is set.

Frequently asked questions

Are medical devices registered with BPOM?

Medical devices follow the Ministry of Health pathway through Regalkes. BPOM handles separate product categories such as food, supplements and cosmetics.

Does every device use the same document checklist?

No. The device, risk class and application type affect the evidence to prepare. The first review should identify the applicable checklist and any product-specific instructions.

Can you give a timeline before seeing the documents?

We can discuss your intended launch, but a useful project estimate requires a product review and document inventory. Preparation and authority review should be planned separately.

Can MDM help coordinate the import stage?

MDM also offers import and export management. Registration and trade work can be scoped together so the teams can coordinate their responsibilities.

BPOM Registration Indonesia · Pharmaceutical Registration Indonesia · Import License Indonesia · All regulatory services

Official references

The dated guide provides technical background. Product-specific requirements and current filing instructions should be confirmed for each application.

Start with your product

Send your product category, country of manufacture, current documentation and intended launch timing. Tell us whether you already work with an Indonesian importer or distributor so we can scope the next steps.

Request a Device Assessment