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
01 Regulatory Pathway
Identify the right classification and regulatory pathway for your device.
02 Product Registration (Izin Edar)
Prepare documentation and secure product registration.
03 Local Licensing & Representation
Establish local representation and obtain company & distribution licenses.
04 Distribution Readiness
Ensure compliant importation, warehousing and distribution (CDAKB compliant).
05 Market Access
Manage government tenders and e-catalog to support your market entry.
06 Post-Market & Compliance
Maintain compliance and fulfill ongoing reporting & vigilance obligations.
How we help
Our Support for Medical Device Companies
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/FSCA, and regulatory updates.
Product Coverage
Completed
Portfolio
Clients
Experience
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.