Global Regulations

The aims and learning outcomes of this course are:

• To understand the Global Regulations for Medical Devices and IVDs.
• To appreciate the EU and global requirements of Medical Devices and IVDs.

Following completion of this course, participants should:

• Understand the basics of Global Regulations for Medical Devices and IVDs.
• Be able to actively participate in preparing documentation for technical files.
• All participants should have a working knowledge of the requirements.

This eight module course is held live in an online lecture theatre and delivered with a PowerPoint presentation.  All participants will fully engage with the lecturer through both group and individual exercises and direct participation throughout the course.  There are exercises included in order to ensure the course contents are fully understood and the opportunity is always available for participants to ask questions.

This course explores the regulations for medical devices around the world and is broken down into 8 modules.

1. Introduction & Regulatory Intelligence

2. Global Regulations

• Canada.
• Australia.
• New Zealand.

3. Global Regulations

• Japan.
• China.

4. Global Regulations

• Latin America.

5. Global Regulations

• Southeast Asia.
• Compilation of an ASEAN STED.

6. Global Regulations

Middle East & Africa.

7. Global Regulations

• CIS Jurisdiction.
• India.
• Korea.

8. Global Regulations

• USA
• The Medical Device Single Audit Programme.