Châu Phùng

I work as a Regulatory Affairs Specialist, focusing on medical device registration in Vietnam. I handle document review, classification, licensing submissions, and communication with manufacturers. I ensure compliance with Vietnamese MOH regulations and support partners throughout the entire registration process.

I am a Regulatory Affairs Specialist with 3 years of experience in medical device registration in Vietnam. I have handled full documentation for registration with the Ministry of Health and hospital tender requirements, covering all device classes (A, B, C, and D). I work directly with manufacturers from Korea and the United States, managing dossier preparation, product classification, compliance checks, and translation of technical and regulatory documents.

I consistently deliver fast approval timelines, with registration certificates issued in as little as 7–9 weeks. I communicate professionally with international partners and manage regulatory processes efficiently to ensure smooth submission, correction, and approval.

I hold an Engineering degree in Applied Physics with a specialization in Biomedical Engineering from Ho Chi Minh City University of Technology, along with a Master’s degree in Mechanical Engineering. This interdisciplinary background gives me strong technical insight into medical devices, material behavior, and regulatory compliance, enabling me to excel in reviewing technical files, evaluating product risks, and supporting medical device registration processes.