Classification
Establishing the Indonesian risk class, which may differ from your home market.
Medical devices
Medical device registration in Indonesia
Medical devices are registered by risk class, and the registration must sit with an Indonesian entity holding the appropriate distribution licence.
At a glance
Risk class sets everything that follows
Classification decides the dossier, the evidence and the timeline. A low-risk instrument and a diagnostic system are not the same project.
The holder question is sharper here than in other families: the registration is tied to an entity licensed to distribute devices, which narrows the options.
- Registered by
- Risk class, from lowest to highest
- Applicant
- An Indonesian entity holding a medical device distribution licence
- Evidence
- Technical dossier, quality system, existing approvals and reports
- Our role
- Classification, dossier, filing and holder structuring
Does this apply to you
Devices, diagnostics and the software that drives them
- Diagnostic and imaging equipment
- In-vitro diagnostic products and reagents
- Single-use and consumable devices
- Devices already approved under CE, FDA or other regimes
- Software intended for a medical purpose
Photo: medical device or diagnostic equipment
Upload it in the panel under Media
Upload it in the panel under Media
What we handle
The scope of work on our side
Dossier build
Technical file, quality evidence and existing approvals assembled for submission.
Holder structure
Identifying or providing an entity licensed to hold a device registration.
Post-market
Renewals, variations and reporting obligations tracked after approval.
Documents
What you send us
- Technical file and product description
- Certificate of Free Sale
- ISO 13485 or equivalent quality certificate
- Existing approvals (CE, FDA, others)
- Instructions for use and labelling
- Letter of appointment
FAQ
Questions we get asked
Does our CE mark or FDA clearance carry over?
It does not replace Indonesian registration, but it is far from useless: existing approvals and the technical file behind them form a substantial part of the dossier. What they cannot do is skip the registration itself.
Will our device sit in the same risk class as at home?
Not necessarily. Indonesian classification is its own exercise, and a device can land in a different class than it does under CE or FDA rules. Since class drives the dossier and the timeline, we establish it before quoting.
Who can hold a medical device registration?
An Indonesian entity holding the appropriate distribution licence. That is a narrower set than for cosmetics or food, and it is worth settling early — including whether you want your own PT PMA to hold it rather than a distributor.
What happens after registration?
Device registrations carry renewal, variation and reporting obligations. We track them, because a lapsed device registration takes the product off the market rather than merely inconveniencing you.
Often needed alongside
Most products need two or three schemes, not one
01
SDPPI / Postel / DJID
Type Approval (SDPPI)
Certification for radio, wireless and telecom equipment — Wi-Fi, Bluetooth, cellular and NFC.
Read more
02
BSN / LSPro
SNI Certification
Mandatory Indonesian National Standard certification for product groups where SNI applies to imports.
Read more
03
BPOM
BPOM Registration
Product registration for cosmetics, food, supplements and medical devices before they can legally be sold.
Read more
Tell us the product. We will tell you what Indonesia requires.
The applicable schemes, the documents required, the testing route and a realistic timeline — in writing, at no cost.
Last reviewed . Indonesian requirements change; we confirm the current position in every assessment.