Exchange of Experience on the Production Quality Management Standards for Innovative Medical Devices Held in Beijing

  • 2024-12-09

On December 5, the Exchange of Experience on the Production Quality Management Standards for Innovative Medical Devices was successfully held at the Zhongguancun Exhibition Center. The meeting was hosted by the China Association for Medical Devices Industry (CAMDI). Mr. Xu Jinghe, Deputy Director of the National Medical Products Administration (NMPA) attended the meeting and delivered an important speech. The meeting was attended by more than 200 participants from Department of Medical Device Registration of NMPA, Department of Medical Device Supervision of NMPA, National Institutes for Food and Drug Control, Center for Food and Drug Inspection of NMPA, Center for Drug Reevaluation, NMPA, China Cultural Media Group, medical products administrations of Beijing, Shanghai, Jiangsu, Zhejiang and Guangdong, CAMDI, manufacturers of innovative medical devices, and manufacturers of medical devices in key areas. The meeting was moderated by Ms. Yang Xiaofang, Deputy Secretary General of CAMDI.
Mr. Jiang Deyuan, Senior Advisor of CAMDI delivered a speech and remarked that Mr. Xu Jinghe’s attendance and speech at the meeting manifested the great attention paid by the regulatory authorities to product quality and industrial development, which was a great encouragement and support for CAMDI and other representatives of participating enterprises. CAMDI will continue to serve national strategies, industrial development and regulatory needs as always, and work together with the community to promote the healthy development of the industry.


Jiang Deyuan, Senior Advisor of China Association for Medical Devices Industry


A number of speakers including Hao Hongwei from Beijing Pins Medical Co., Ltd., Liu Wenbo from Sinovation (Beijing) Medical Technology Co., Ltd., He Tao from Shanghai Pulse Medical Technology, Inc., Wang Pei from Shenzhen Mindray Bio-Medical Electronics Co., Ltd., and Xu Yaling from Zylox-Tonbridge Medical Technology Co., Ltd., introduced and exchanged ideas on key elements such as intelligent production, design and development, product change control, procurement and material management, and commissioned production management, respectively.


Hao Hongwei, Head of Beijing Pins Medical Co., Ltd.

Liu Wenbo, Co-Founder & Co-CEO of Sinovation (Beijing) Medical Technology Co., Ltd.


He Tao, Management Representative of Shanghai Pulse Medical Technology, Inc.

Wang Pei, Management Representative/General Manager of Quality Center, Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Zhuang Yaping, Senior Director of Quality Regulation, JC Medical, Inc.

Xu Yaling, Management Representative of Zylox-Tonbridge Medical Technology Co., Ltd.


Chen Yan, Director of Center for Food and Drug Inspection of NMPA, introduced the progress of the medical devices quality system verification (inspection).


Chen Yan, Director of Center for Food and Drug Inspection of NMPA

Mr. Xu Jinghe, Deputy Director of NMPA made an important speech. He noted that it was stated at the Third Plenary Session of the 20th CPC Central Committee that we must develop new quality productive forces and improve the development mechanism of innovative drugs and medical devices. In recent years, NMPA has attached great importance to the approval and regulation of innovative medical devices, and CAMDI also has made a lot of efforts to promote industry self-regulation and social co-governance. He hoped that all participating representatives could learn and be serious about the exchange content, have a deep understanding of the particularity of medical device products from the eight dimensions that “Prioritize Product, Health, Safety, Quality, and Value Risks, Responsibilities, Systems and Capabilities”, gain insight into the importance of the medical device quality management systems, effectively implement the main responsibility for quality and safety, and promote the high-quality development of China’s medical device industry.


Xu Jinghe, Deputy Director of NMPA

The meeting provided authoritative guidance and exchanges for innovative medical devices and medical device manufacturers in key areas, and was recognized and praised by leaders and representatives attending the meeting.

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