Regulation of IVDs for Key International Markets

This course will cover IVD regulatory requirements in three key markets—Europe, Canada and Japan. Key topics within each market include IVD risk classifications, manufacturer’s premarket responsibilities, labeling requirements and post-market surveillance requirements. The unique regulatory structure in each market will be examined, with clear directions regarding the process for obtaining market clearance. Ongoing efforts toward harmonization of regulatory requirements, including use of harmonized standards such as ISO 13485 for establishing an effective and robust Quality Management System is also discussed.

  • At A Glance
  • Learning Objectives
  • Lesson Titles
  • Registration Options

At A Glance

  • Target Audience: This course is for regulatory professionals with one to three years’ experience and those wanting to expand their knowledge of international regulatory requirements for IVDs.
  • Learning Level: Basic
  • Total Length of Course: 4–8 Hours
  • RAC Points: 4
  • Formats: PC and Tablet (iPad and Android)
  • Cost: Member $455; List $630
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Learning Objectives

Upon completion of this course, participants will be able to:

  • Properly identify the IVD category or risk classifications applicable in each of the subject markets
  • Describe and understand the regulatory requirements for obtaining market clearance
  • Identify an appropriate path for obtaining market clearance in Europe, Canada or Japan, and understand where to seek further guidance
  • Identify core requirements common to IVD regulation in most global markets

Lesson Titles

  • Lesson 1: IVD Medical Device Global Regulatory Framework
  • Lesson 2: Europe
  • Lesson 3: Canada
  • Lesson 4: Japan

Registration Options

This course is available for purchase as follows: