SeerPharma Pty Ltd :: DISCover web-based training :: MD-A 2: Requirements for Registration (Australia)

UK | Singapore | Korea

MD-A 2: Requirements for Registration (Australia)

Description: In this course, you will be introduced to the activities that are required before a medical device is ready to go to market. The course will explain the term intended purpose, the medical device classification system, GMDN codes, and conformity assessment certification systems for devices registered in Australia with the TGA.

Price: $179 (AUD)

(Australian customers, please add GST.)

Note: We use 128-bit SSL security encryption on all webpages where private information is taken.

Terms and conditions

COURSE OUTLINE

INTRODUCTION
1. Welcome
2. Introduction
3. Assessment
4. Overview

MANUFACTURER ACTIVITIES
5. Intended Purpose
6. Classification System
7. Risk Factors
8. Special Classification Rules
9. Review

GMDN CODE
10. Introduction
11. GMDN Categories
12. Device Groups and Device Types

CONFORMITY ASSESSMENT
13. Introduction
14. Declaration of Conformity
15. Conformity Assessment Procedures
16. Conformity Assessment Procedures

CLASSIFICATION
17. Conformity Assessment Certification
18. Global Mutual Recognition
19. Review

TECHNICAL DOCUMENTATION
20. Introduction
21. Product Description
22. Technical Requirements
23. Design
24. Review

CLINICAL EVIDENCE
25. Introduction
26. When Is Clinical Evidence Needed?
27. Experimental Medical Devices
28. Review

REGISTRATION PROCESS
29. Introduction
30. Starting the Process
31. Manufacturer Evidence
32. Submit Application
33. TGA Inclusion Certificate
34. Review

CONCLUSION
35. Summary

COURSE OBJECTIVES

Students completing this course should be able to:

Explain the term "intended purpose"
Explain the structure of the classification system
Describe the impact of risk on classifications
Explain what clinical evidence needs to be demonstrated
Describe the key sections of the technical file

Home

Training Programs

Upcoming Training

Compliance Consulting

DISCover e-Learning

Modules available

SOPtrain

Quality Management Software

Clinical Trials Software

SeerPharma has partnered with GeneEd to now distribute courses in Major Therapeutic Areas, Clinical Research, and Biotechnology & Genetics.