Medical Device Solutions in Indonesia
End-to-end support for medical device companies to navigate regulatory requirements, obtain market access, and grow sustainably in Indonesia.
What you need in Indonesia
01Regulatory Pathway
Identify the right classification and regulatory pathway for your device.
02Product Registration (Izin Edar)
Prepare documentation and secure product registration.
03Local Licensing & Representation
Establish local representation and obtain company & distribution licenses.
04Distribution Readiness
Ensure compliant importation, warehousing and distribution (CDAKB compliant).
05Market Access
Manage government tenders and e-catalog to support your market entry.
06Post-Market & Compliance
Maintain compliance and fulfill ongoing reporting & vigilance obligations.
How we help
Regulatory Advisory
Advice on classification, requirements, and strategy to align with Indonesian regulations.
Product Registration (Izin Edar)
End-to-end support from document preparation, submission, to approval.
Local Licensing & License Holding
Local representative services and support for company and distribution licensing.
Importation & Distribution Support
Importation process, customs coordination, warehousing and CDAKB implementation.
Market Access Support
Management of government tenders and e-catalog to support your commercial access.
Post-Market Compliance
License maintenance, reporting, vigilance/PSCA, and regulatory updates.
Product Coverage
and many more
From Market Entry to Market Access
1. Assess
Assess product and
regulatory requirements
2. Classify
Determine product
classification
3. Prepare
Prepare documents
and technical files
4. Register
Submit and follow up
until approval
5. Distribute
Obtain license and
prepare distribution
6. Market Access
Manage government tenders
and e-catalog
7. Grow
Expand your presence
in Indonesia
Planning to bring a medical device to Indonesia?
Tell us about your product, current regulatory status, and market-entry goals.
Our team can help you identify the next step.