chapter  1
4 Pages

How to Train University Students in Regulatory Affairs

On completion of the course, students will be able to demonstrate their understanding of how to meet the standards and regulatory requirements, and they will be able to handle regulatory tasks, including classification, risk management, ISO standard, product registration, and commercial materials review. Students will be trained to understand the global, regional, and local medical device regulatory requirements and trends. Besides conducting lectures, students will be arranged into a small group to work on a medical device and practice preparing a medical device registration submission to a competent authority. The competent authority is a body that has authority to act on behalf of the government to ensure that the requirements of the medical device directives are transposed into the national law and are applied. Guest lecturers with regulatory experience and network will be invited to share their experience. Students who finish the course will be eligible for attending related medical device regulatory examination conducted by external bodies, such as notified bodies and the Asia Regulatory Professional Association.