Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Rule 3: Class C

• Sexually transmitted diseases • Life threatening Infectious disease • Companion diagnostic • Cancer screening • Genetic testing • TDM • Pre-natal and neonates

The Organisation for Professionals in Regulatory Affairs

7

Rule 4: Class C

• Self-test devices • Near-patient tests classified in their own right

The Organisation for Professionals in Regulatory Affairs

8