国际医疗器械设计与制造技术展览会

Dedicated to design & manufacturing for medical device

September 25-27,2024 | SWEECC H1&H2

EN | 中文
   

The 5th Edition of Regulatory Lecture: Practice for Product Compliance and Market Launch

September 26, 2024 | Meeting Room B, Hall 1, Shanghai World Expo Exhibition & Convention Center, Shanghai, China

 

Background:

Medical devices are directly applied for the human body, their quality and safety are directly related to people’s health and safety. Governments of various countries ensure the quality, safety and efficacy of medical devices by establishing and enforcing medical device laws and regulations and implementing well-organized rigorous registration and marketing procedures, thus protecting health of the people. At the same time, it is also crucial for companies to produce compliant medical devices under the guidance of regulations to improve their core competitiveness.

 

Purpose:

  • Discuss the key regulations and response strategies in the medical device industry
  • Seek ways to accelerate the medical device products launch
  • Jointly promote the innovation and development of medical device products
  • Combine with the concurrent exhibitions to provide a platform for medical device regulatory practitioners to communicate and interact with each other

 

Participants:

  • Medical device manufacturers: heads of the departments of registration, quality, compliance, medical, and R&D, as well as project/company leaders
  • Domestic and international providers engaged in medical device regulatory consulting, testing, certification, inspection, clinical trials, etc.
  • Medical device regulatory agencies and research organizations

 

Agenda:

Time

Agenda

9:50-10:00

Moderator Remarks

10:00-10:30

Experience Sharing on FDA Certification Related Problems and the Countermeasures

10:30-11:00

MDR Policy and its Impact on Manufacturing of Enterprises
凌仕医疗(Reserved)

11:00-11:30

Medical device access Policy and Layout in Southeast Asian Countries
凌仕医疗(Reserved)

11:30-12:00

Case Sharing – Overseas Declaration and Registration Strategy for Innovative Medical Devices
XINNUO(Reserved)

12:00-13:20

Lunch & Exhibition

13:20-13:30

Moderator Remarks

13:30-14:00

Key Points and Practical Experience Sharing in Animal Experiments
Wuxi AppTec (Reserved)

14:00-14:30

Requirements for Review of Plant Interventional Materials
Wuxi AppTec (Reserved)

14:30-15:00

Method for Declaring the Availability of Medical Devices for Registrants
Wuxi AppTec (Reserved)

15:00-15:30

Facing Temporary Inspections: Sharing Quality Management Skills in Enterprises
Wuxi AppTec (Reserved)

15:30-16:00

UDI Review of Medical Beauty Devices
Wuxi AppTec (Reserved)

16:00-16:30

Biocompatibility Testing of Local Tissue Reactions in Medical Devices
Wuxi AppTec (Reserved)

16:30-16:40

Conference Close

*The agenda may be subject to changes due to adjustment of confirmed speakers

 

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