Regulatory Affairs

Medical device registration : Aesthetic and plastic medical devices from Class 1 to Class 4 registration and management (TFDA)

Regulatory Research and Updates: Continuously monitor domestic and international regulatory environments and policy changes, and update internal policies and procedures accordingly to reflect them in product development and launch processes.

Document Management and Reporting: Systematically manage authorization-related documents, test reports, and safety data, and report to or respond to authorities when required.

Internal Training and Collaboration: Work closely with departments such as development, production, quality, and marketing to share regulatory requirements and provide training and advice to ensure compliance.

Problem Solving and Response: When delays, regulatory risks, or discrepancies occur, develop solutions, communicate with authorities, and manage product recalls or withdrawal issues.