Introduction

Agenda

Speaker

Sponsor/Package

Registration

Transportation

MDiT Forum and Regulation Summit 2022—— Technology Track K: The 5th Session of Pack&Ster Hub

Afternoon of December 8 | Conference Room C, Hall D1, SUZHOU INTERNATIONAL EXPO CENTER
Co-organizers: Medtec China

Conference Background:

• With the emergence of new technologies in recent years, a large number of new special materials and technologies applicable to the production of medical device packaging have been introduced, and the new ISO 13485:2016 standard adds a large number of best practices in the medical device industry and is compatible with the requirements of medical device regulations in Europe and the United States, etc. The new standard for design and R&D and other requirements can help enhance the independent R&D capabilities of devices and ensure the safety and effectiveness of medical devices, thus enhancing medical device companies' competitiveness.
• At the end of 2018, the Instrument Review Center of NMPA publicly solicited comments on the Guidelines for Technical Review of Registration of Reprocessing Verification Methods and Identification of Reusable Medical Devices (I) (Draft for Comments). At the end of 2019, the NDA IDRC publicly solicited comments on the Guidelines for Technical Review of Registration of Reprocessing Instructions and Confirmation Methods for Reusable Medical Devices (II) (Draft for Comments). With the reusable medical device reprocessing exposure drafts coming out one after another, the government is paying more and more attention to the field of reusable medical device reprocessing, and the requirements are getting stricter and stricter. How to choose the best solution for reusable medical device sterilization?
• As an essential part of medical device products, medical device markings assume the role of marking product and production information, meeting traceability requirements, providing the necessary safety and warning information, etc. Its importance is self-evident, so how to deal with the sterilization of the unique markings of implantable medical devices?
• Packaging exhibitors in Medtec China and global not only provide the advanced techniques and service, also devote to improve quality of sterile product. Due to success of the 2017 to 2020 conferences, this year’s conference will continue to combine the requirement from manufacturers and suppliers, together with the Medtec global resources to explore the testing, technology and approaches of medical device packaging and sterilization.

Who Should Attend?

• Quality, Process Validation, Supplier Management, Sterilization Packaging, Production and Technology Department, Project Manager/Director and Managing Director from medical devices manufacturers
• Packaging, packaging equipment and service suppliers
• Consulting, CRO and research institutes focusing on packaging and sterilization

*Conference agenda updates according to speaker confirming.

>> Medtec China 2022 MDiT Forum and Regulation Summit

Steven He, Director of Applied Technology R&D, Xiamen Dangs New-Materials Co., Ltd
Kai Cao，Sr. FTS engineer，Amcor China Healthcare
Alex Yao，EHS Manager Shanghai，Sterigenics ETO (Shanghai) Co., Ltd.
Yuancheng Lu, Packaging Sales Engineer , Shanghai Jianzhong Medical Equipment Packing Co., Ltd.

Xiamen Dangs New-Materials Co., Ltd
Xiamen Dangs New-Materials Co., Ltd
Shanghai Jianzhong Medical Equipment Packing Co., Ltd.

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