China Food and Drug Administration’s (CFDA’s) – GMP for Implantable Medical Devices

Description:

This course focuses on providing an understanding of the Chinese Food and Drug Administration’s (CFDA’s) Announcement on issuing an Appendix of Implantable Medical Devices to Good Manufacturing Practices for Medical Devices, 2015 Number 102. These regulations are outlined in four parts which will be covered in this course. The purpose of this course is to present the regulations in a clear and concise manner in order to provide participants with the necessary information required to maintain the safety and efficacy of medical devices as specified by the CFDA.

Curriculum for this course:
Introduction
Overview 1 min 01 secs
Who Should Take This Course? 1 min 31 secs
Learning Objectives 1 min 21 secs
Introduction to CFDA Appendix to GMPs for Implantable Medical Devices
Supplementary Provisions (Part 4) 1 min 05 sec
Terminology (Part 3) 1 min 10 secs
Part 1: Scope and Principles 1 min 10 secs
Part 2: Introduction to Special Requirements 1 min 17 secs
2.1 Personnel
Education and Training 1 min 12 secs
Hygiene, Health, and Clothing Requirements 1 mins 29 secs
2.2 Workshops and Facilities
General Requirements 1 min 01 secs
Acceptable Cleanliness Levels Part 1 1 min 13 secs
Acceptable Cleanliness Levels Part 2 1 min 33 secs
Clean Room Environment 1 min 06 secs
Plumbing, Pest Control, and Other Environmental Requirements 1 min 19 secs
2.3 Equipment
2.3 Equipment 1 min 15 secs
2.4 Design and Development
2.4 Design and Development 1 min 23 secs
2.5 Procurement
General Requirements 1 min 01 secs
Implantable Animal-Derived Medical Devices 1 min 02 secs
Implantable Allogenic Medical Devices 1 min 10 secs
2.6 Manufacturing Management
General Requirements 1 min 11 secs
Sterilization 1 min 33 secs
Traceability 1 min 09 secs
Packaging and Storage 1 min 15 secs
Animal-Derived and Allogenic Medical Devices 58 secs
Cleaning, Disinfection, and Pest Control 1 min 40 secs
2.7 Quality Control
2.7 Quality Control 1 min 15 secs
2.8 Marketing
2.8 Marketing 1 min 09 secs
2.9 Monitoring, Analysis, and Improvement of Adverse Events
2.9 Monitoring, Analysis, and Improvement of Adverse Events 1 min 36 secs
Conclusion
Final Assessment
Certification
Author:

Have a question?

Find out how we can help you bring your life science training to the next level.

Book a FREE demonstration