Authorized Representative Services
Management Systems · Medical Devices
Service scope
We provide authorized representative services for countries and regions including the European Union, Russia, Vietnam, Malaysia, Brazil, Saudi Arabia, etc., acting as the local compliance contact for enterprises.
Our strengths
Local Entity Guarantee: We have established local physical entities in core markets including the European Union, Russia, Vietnam, Malaysia, Brazil and Saudi Arabia, meeting the entity requirements for authorized representatives stipulated by local regulations;
Full-Process Compliance Service: We provide full-chain services covering technical document review, communication with competent authorities, adverse event reporting, product change declaration, annual compliance maintenance and other related services.
Service process
Service Signing: Clarify the service scope, term and rights and obligations of both parties, and sign the authorized representative agreement
Document Review: Review the enterprise's product technical documents and compliance materials to ensure compliance with local regulatory requirements
Compliance Liaison: Act as the enterprise's official local liaison, coordinating with competent authorities, notified bodies and other relevant institutions
Daily Maintenance: Provide services such as adverse event reporting, product change declaration, and annual compliance review
Regulatory Update: Synchronize the latest local regulatory requirements and assist enterprises to complete compliance upgrades