The newly revised Regulations for Supervision and Administration of Medical Devices established the chapter on Adverse Event Handling and Medical Devices Recall, with the purpose to enhance the control over regulate supervisory activities throughout the whole product life cycles.
This webcast introduces the new regulations related to the post market surveillance under order 650 and highlights the requirements on products and distribution. The challenges led by these new relations are also discussed in this webcast. You will also learn how to apply the quality management system to support the regulatory compliance.
- Understand the regulatory background of post market supervision China
- Outline the key messages from provisions related to post market supervision under Order 650
- Understand how to apply the QMS to support the regulatory compliance
Who should attend
- Regulatory Affair professionals
- Quality Assurance professionals
Jennifer Han, senior manager of RA and QMS, 3M China HCBG
Jennifer Han is the senior manager of regulatory affairs and quality management systems for 3M China. She is experienced in MQS setup and maintenance, providing the National Provider Identifier (NPI) process regulatory and quality compliance direction. Han is a key member of Dressings and Asepsis Product Standard Committee, working on product standardization. She graduated from China Medical University with a degree in Japanese Medicine.