Indonesia · Medical Devices
Indonesia Medical Device Registration
A practical guide to Indonesia Medical Device Registration for medical devices sold in Indonesia: who it applies to, what to prepare, and the mistakes that cause rejection.
Who needs this
- Manufacturers and importers of medical devices and IVDs
- Brands distributing devices through local partners
Documents you need
- Regulatory classification and registration
- Clinical or performance evidence
- Quality management system certificate
- Labelling and instructions for use
Compliance checklist
Tick each item as you collect it. Saved in this browser only.
How to comply
- Classify the device under local rules
- Prepare technical documentation
- Complete registration or notification
- Maintain post-market surveillance
Brief for your lab or agent
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Request: Indonesia Medical Device Registration — Indonesia Product category: Medical Devices Authority: Ministry of Health Legal basis: Health Law 36/2009 Documents we already have: 1. Regulatory classification and registration 2. Clinical or performance evidence 3. Quality management system certificate 4. Labelling and instructions for use Questions: 1. Does our product fall under Indonesia Medical Device Registration in Indonesia? 2. Which test standards or evidence do you accept? 3. What is the current fee and lead time? 4. Is a local representative required, and can you act as one?
Cost and timeline
Registration can take months; plan early.
Clinical evidence and QMS audits dominate cost.
Common rejection reasons
- Wrong risk classification
- Clinical evidence insufficient
- QMS certificate not accepted
- Labelling incomplete
Official sources
FAQ
Who needs Indonesia Medical Device Registration in Indonesia?
Manufacturers and importers of medical devices and IVDs. Brands distributing devices through local partners. The importer of record normally holds the evidence.
What documents do I need for Indonesia Medical Device Registration?
Regulatory classification and registration; Clinical or performance evidence; Quality management system certificate; and labelling and instructions for use.
What is the first step for Indonesia Medical Device Registration?
Classify the device under local rules, then prepare technical documentation. Registration can take months; plan early.
How long does Indonesia Medical Device Registration take?
Registration can take months; plan early.
How much does Indonesia Medical Device Registration cost?
Clinical evidence and QMS audits dominate cost.
What happens if I sell without it?
Import ban, seizure, and enforcement action.
Who regulates Indonesia Medical Device Registration in Indonesia?
Ministry of Health.
Related requirements
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