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

Medtec China 2024 onsite conference—— The 5th Edition of Regulatory Lecture: Practice for Product Compliance and Market Launch

Co-organizers: Medtec China

Introduction

Conference 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

Who Should Attend:

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

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

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

Speaker

TBD

Sponsor/Package

Sponsorship&Promotional Opportunities Medtec China 2024

Registration

Click to register now

Transportation

Click to see venue information

Speech & Cooperation

Rebecca Lv

T: +86-21 6157 7279

E：Rebecca.lv@informa.com

Sponsor & Paid Conference

Lorelei Yu

+86-21-61573861

E：Lorelei.Yu@informa.com

Media & Free Conference

Carina Li

T：+86 10 6562 3307

E：Carina.li@informa.com

Medtec China 2024 onsite conference—— The 5th Edition of Regulatory Lecture: Practice for Product Compliance and Market Launch

Co-organizers：Medtec China

Conference Background:

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

Who Should Attend?

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

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

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