The Third Medical Device Registration Verification and Post-Market Regulation Summit Forum Ended on a Successful Note

  • 2018-10-17

On October 12, 2018 the Third Medical Device Registration Verification and Post-Market Regulation Summit Forum, co-sponsored by China Association for Medical Devices Industry (CAMDI) and Wuhan Tacro Technology Co., Ltd. (hereinafter referred to as Tacro), ended on a successful note in Sinopharm Plaza (Wuhan National Bio-industry Base). The Summit Forum was presided over by Mr. Wu Nan, director of Government Affairs of Tacro and executive deputy general manager of Tacro (Beijing branch). At the Summit Forum site, 12 competent industry leaders and experts share their experience towards over 200 participants nationwide in regards to new trends, new regulations, new supervision and other aspects of medical devices industry.


Mr. Wu Nan, director of Government Affairs of Tacro and executive deputy general manager of Tacro (Beijing branch)

In the beginning, the opening speech was given by Mr. Liu Lili, secretary of the Party Committee and executive deputy director of Construction Administration Office of Optics Valley Modern Service Industrial Park. On behalf of Optics Valley, Liu pointed out the significance of the event and extended his cordial wishes to the Summit Forum. Among all the enterprises in eight parks of Optics Valley, Tacro led by Mr. Zeng Jianhui (CEO) devotes itself to medical devices industry, which move deserves our respect and admiration. China’s medical devices industry is in its core period of opportunities – the reform of medical device registration system will bring tremendous value and opportunities to all the enterprises. In the meantime, Liu added that the Construction Administration Office of Optics Valley Modern Service Industrial Park will always be the strong backup for those entrepreneurs committed to making their dreams come true in Optics Valley.


Mr. Liu Lili, secretary of the Party Committee and executive deputy director of Construction Administration Office of Optics Valley Modern Service Industrial Park

Mr. Zhang Quan, CEO of Wuhan Optics Valley Finance Holding Group Co., Ltd., pointed out that Tacro has achieved great results in this autumn – a time of harvest. By upholding the principles of “medical devices focused” and “talents first”, Tacro has realized inspiring and profound achievements in its own development and transformation – from a four-person team to a large-scale medical devices platform and from only local services provided to services projects worldwide available.


Mr. Zhang Quan, CEO of Wuhan Optics Valley Finance Holding Group Co., Ltd.

Mr. Chen Lei, managing partner of Insight Capital, mentioned in his speech that Insight Capital, as one of the first to invest in Tacro, was heartened by its sound development – from local to global and from CRO to the integrated platform CDMO.


Mr. Chen Lei, managing partner of Insight Capital

In his speech, Zeng first expressed his heartfelt thanks to all the competent leaders, experts and participants on site. He also added that Tacro would not be where it is today without core competitiveness, and the core competitiveness originates from its interior excellent talents group and determined supporters. Tacro’s future will also rely on the talents and growing circle of friends to join the company.


Mr. Zeng Jianhui, CEO of Wuhan Tacro Technology Co., Ltd.


Mr. Liang Yong (left), general manager of Wuhan Best City, and Mr. Xu Peng (right), deputy general manager of Wuhan Tacro Technology Co., Ltd. unveiled the nameplate for “Medical Devices Innovation Promotion Platform in Optics Valley”.

A keynote speech themed on “New Opportunities of China's Medical Device Industry in the New Era” was delivered by Mr. Fan Xiaodong, vice president of CAMDI. In his speech, Fan indicated that China is undergoing the rapid transformation of technology, industry and economy. In this context, emerging concepts such as big data and artificial intelligence based on the internet are gushing into the medical devices industry. The industrial chain of economy in China still needs to be improved and strengthened because of the fast and unpredictable scientific and technological development. At present, the aging problem is intensifying in China and the demands for rehabilitation and chronic disease management is expanding. With the promotion of Major Health Strategy, China's medical device industry is facing new opportunities and has great potential to increase its share of GDP.


Mr. Fan Xiaodong, vice president of CAMDI

Ms. Wang Aijun, director of the Division of Medical Devices of Center for Food and Drug Inspection of China Food and Drug Administration (CFDA), dissected the status and key work of unannounced inspection of medical devices of domestic and overseas enterprises by presenting detailed data in recent years. Meanwhile, she gave a detailed analysis on the problems of enterprises during the inspection. In the end, Wang made a brief introduction about the work direction in the future.


Ms. Wang Aijun, director of the Division of Medical Devices of Center for Food and Drug Inspection of China Food and Drug Administration (CFDA)

Ms. Ren Haiping, director of Optic-mechanical-electric Department of Institute for Medical Devices Control of National Institutes for Food and Drug Control (NIFDC), shared her insights of medical device inspection and technical services. By listing the regulations and supervision systems related to medical devices, Ren introduced the challenges faced by the medical devices inspection laboratories. She also reminded that all the organizations and enterprises should pay attention to the adjustment of strategies and attach importance to win-win cooperation.


Ms. Ren Haiping, director of Optic-mechanical-electric Department of Institute for Medical Devices Control of National Institutes for Food and Drug Control (NIFDC)

Mr. Guo Lei, secretary of the Board of Directors and director of Innovation Division of Tacro, shared the experience that how Tacro established its own technology transformation platform for medical devices when the technology transformation of medical devices in China is becoming more and more difficult.


Mr. Guo Lei, secretary of the Board of Directors and director of Innovation Division of Tacro

Mr. Jiang Haihong, the director of Medical Device Supervision of Shanghai University of Medicine & Health Sciences analyzed the prospect and legal risks of the marketing authorization holder system for medical devices.


Jiang Haihong, the director of Medical Device Supervision, Shanghai University of Medicine & Health Sciences

Li Jing, the director of Business Department, Hubei Medical Devices Quality supervision and Test Institute, analyzed the major problems in the supervision and test of medical devices.


Li Jing, the director of Business Department, Hubei Medical Devices Quality supervision and Test Institute

Cai Yang, a medical device reviewer from Hubei Food and Drug Administration, analyzed the major problems in the review of active medical devices.


Cai Yang, a medical device reviewer from Hubei Food and Drug Administration

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