Training on the Direct on-line Reporting System for Voluntary Recalls of Medical Devices

2018-10-25 | Beijing, Shanghai

Training on the Direct on-line Reporting System for Voluntary Recalls of Medical Devices

Organized by the Healthcare Equipment Working Group of the European Chamber, and supported by the SHFDA, the launching training on the direct on-line reporting system for voluntary recalls of medical devices was successfully held in Shanghai.

The enterprises are getting stronger sense of being as the primary obligator for their products in the market, and in order to keep active cooperation with the Shanghai Food and Drug Administration (SHFDA) over medical device supervision and management, on October 25, 2018, organized by the Healthcare Equipment Working Group of the European Union Chamber of Commerce in China (EUCCC), and supported by the SHFDA, the launching training on the direct on-line reporting system for voluntary recalls of medical devices was successfully held in Shanghai.

At the meeting, Mr. Huang Yiwu, Deputy Director of the Division of Medical Device Supervision introduced the planning and programming of the system, which is an important task of the SHFDA to deepen reforms to streamline administration and improve legislation and services, in an effort to speed up the “internet service for government affairs” and provide administrative counterparts with quicker and more efficient services. It will make it easier for enterprises to report product recalls and on-line manage documents related. Also convenient for communicating, sharing and analyzing recall information, to form supervision coordination.

Ms. Yuan Jie (Jessica), the person in charge for the Healthcare Equipment Working Group of the Chamber, also spoke at the meeting. She thanked the SHFDA for their efforts to unshackle the restraints and incentivize the innovation in the industry. Yuan said that member companies will continue to shoulder the responsibility of medical device adverse events monitoring and defective product recall, enhance risk-prevention awareness, and actively cooperate with the drug supervision department to implement for a scientific and efficient supervision.

Invited by the Division of SHFDA, the designers and maintainers of the system gave a training to the participants – explaining the details of the system, doing operation demonstration and Q&A. Mr. Huang also answered questions from participants to help them get a better understanding.

About 60 people from member companies of the Healthcare Equipment Working Group, EUCCC, participated in the training. This training is generously supported by BSC Int'l Medical Trading (Shanghai) Co., Ltd., a member of the Consumable and Disposable Medical Device (CDMD) Advisory Committee of the Chamber.