Seamless BPOM Registration Process
Importing goods into Indonesia requires full compliance with local regulations. Without the proper licenses and permits, your shipments risk delays, fines, or rejection at customs. Whether you’re a domestic distributor or an international company entering the market, we simplify the import licensing process for a smooth market entry.
We assist in securing all required licenses and approvals from the Ministry of Trade to ensure your import activities are compliant and efficient.
Your Trusted Partner for Compliance
Comprehensive Support for a Smooth Registration
We handle every aspect of your medical device registration with precision, so you can focus on confidently launching your products.
Pre-Registration Guidance
We evaluate your products and business to determine the right license and assist with the necessary documents, including your NIB via the OSS system and relevant permits.
Document Preparation & Labeling
We manage all documentation, including the ASEAN Common Submission Dossier Template (CSDT), and ensure labeling and instructions for use (IFU) meet Bahasa Indonesia compliance.
MoH Submission & Approval
We liaise directly with MoH authorities to submit your application and secure approval, managing all communications for smooth processing.
Post-Approval Maintenance
We provide continuous support for renewals, updates, and compliance management to keep your product legally marketable.