Your Trusted Partner
for Compliance
Years Track Record
Clients Worldwide
Professionals
Comprehensive Support for a Smooth Registration
We manage every detail of your medical device registration, ensuring accuracy and compliance. Focus on bringing your products to market while we handle the rest.
Pre-Registration Guidance
We offer guidance on device classification (Class A, B, C, or D) and regulatory strategy, ensuring you understand requirements before we start.
Document Preparation & Labeling
End-to-end assistance compiling the ASEAN Common Submission Dossier Template (CSDT) and Indonesian-language labeling/IFU compliance.
MoH Submission & Approval
Liaise with MoH authorities to submit your application and obtain the product license while we handle communications for swift approval.
Post-Approval Maintenance
We offer ongoing support for license renewals and compliance updates, keeping your device marketable.
Getting Your Product Market Ready
Expert Guidance
From initial assessment to final certification, our experts ensure that every requirement is met correctly the first time.
Comprehensive Support
We simplify the approval process by managing documents, certificates, and applications for you.
Local Representation Advantage
We fulfill Indonesia’s local license holder requirements, giving you complete control of your product’s distribution.
Ongoing Partnership
We continue assisting with renewals, audits, and product updates, ensuring your registrations stay current and compliant.
