Global regulations and standards for biomedical products

In many countries, products used in health care are subject to regulations. However, there are differences in the regulations and requirements of different countries in addition to differences in practices. Up-to-date knowledge of regulations, standards, and requirements is the key to a successful journey in global markets.

This online course focuses on regulations and standards for biomedical products in the global market. The focus will be on Asia, Africa, America, and Australia.

The course covers the following topics:

• Key regulations, standards, authorities, and regulatory pathways
• Classification and requirements for different product types
• Special programs, harmonization, and global organizations
• Labeling

After completing this course, you will:

• understand the wide range of global regulations and standards related to biomedical products and their key differences
• know key global authorities and find information related to them
• understand the challenges that different actors can face when operating in the global biomedical product market
• be able to solve various example cases related to the topic and apply what you have learned in your future work

Teaching

The course is online, which participants can complete at their own pace. The course is open from January 7 to April 30, 2025.

The course is divided into 6 themes. Each theme includes different materials, such as videos, reading or listening, and assignments. The next theme can be reached after completing the previous one. The course also includes a written learning assignment that can be applied to the participant’s organization.

Although the course is largely conducted independently online, the teacher is available when needed during office hours. The teacher also gives feedback on the assignments during the course.

Target group

This course is targeted for those who are working or willing to work in medical and health technology companies in different roles in R&D, quality and regulation, production, marketing and sales, and management. The course gives essential knowledge also for health technology start-ups and anyone who wants to update his or her knowledge about global regulations and standards.