Dr. Amit Kumar Chaudhary is a scientific / student assistant of international Biomedical Engineering Master Program in University of Applied Sciences Lübeck, Germany. His core focus is on regulatory affairs of medical devices including IVDs. He has more than seven years of working experience in T.U. Teaching Hospital, Nepal as a chief biomedical engineer. He worked as a consultant biomedical engineer to the "Commission for the Investigation of Abuse Authority" and various government hospitals, Nepal. His master research internship was on "Analysis and finalization of an international guidance document as harmonized approach for a biosafety and biosecurity regulatory framework with regard to biomedical laboratories" in cooperation with the World Health Organization (WHO), Geneva & the University of Applied Sciences Lübeck, Germany. He has contributed to publish a "WHO guidance on implementing regulatory requirements for biosafety and biosecurity in biomedical laboratories – a stepwise approach" (draft – under publication by WHO, Geneva). Recently, he has submitted a report to the Government of Nepal, DDA, GTA, various government stakeholders in Nepal and WHO-Nepal on "Analysis of the current situation of Nepal to design a harmonized approach for the regulatory framework for medical devices and for strengthening quality management, biosafety and biosecurity in biomedical laboratories".