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[Invitation] Medical Device Testing & Registration Seminar

发布时间：2020-11-13阅读量：1来源：

[Invitation] Medical Device Testing & Registration Seminar

Introduction

On November 25, the "Medical Device Testing & Registration Seminar" jointly hosted by Regis Medical • HiMed and Passive Medical Device Testing will be held at Zhangjiang Xiangke Road. This event aims to better understand the current technological trends in the medical device market, share key points of medical device registration, and discuss related experiences. We look forward to your registration and participation.

1. Organization

Hosts

Shanghai Passive Medical Device Testing Technology Service Co., Ltd.

Beijing Regis Medical Technology Co., Ltd.

Organizer

Shanghai Yanxitang Enterprise Management Co., Ltd.

2. Time & Location

Location:

Shanghai, China

Seminar Time:

November 25, 2020, 13:30 - 16:30

Address:

Zone B, 5F, Building B (Building 2), No. 58 Xiangke Road, Zhangjiang, Pudong New Area, Shanghai — HiMed International Medical Innovation Center

3. Agenda

Speaker: Dong Weimiao

Project Manager at Shanghai Passive Medical Device Testing Technology Service Co., Ltd. Graduated from Shanghai Fisheries University with a major in Food Inspection. Worked at SGS, the world's largest third-party testing institution, from 2006 to 2011, and at TUV SUD from 2012 to 2019. His main business areas include: medical device (cleaning, disinfection, sterilization) validation, product shelf-life validation, and packaging material aging testing.

Topic: Cleaning Validation for Reusable Devices

Cleaning validation is an essential part of the use process of reusable medical devices. Due to various factors such as users, usage environment, and contaminants, medical device products inevitably carry various contaminants, making it necessary to clean the products. For products that require sterilization or disinfection before use, cleaning is particularly important.

Speaker: Wang Jiajun

Director of the Registration Division at Beijing Regis Medical Technology Co., Ltd. With over 10 years of experience in medical device regulatory registration, he formerly served as Registration Department Supervisor at the largest listed medical device regulatory consulting institution in China, and as Regulatory Affairs Manager at Philips (China).

Topic: Key Points of NMPA Medical Device Registration under the Current Regulatory Environment

With the development of China's medical device registration industry, the NMPA and CMDE have successively promulgated and updated medical device industry guidelines and regulations, aiming to improve industry standards and processes. Committed to deeply cultivating the medical device registration field, Regis continuously updates and summarizes industry and review trends.