On October 19, 2020, the first day of the 83rd CMEF, the “Sixth Registration Verification and Post-Marketing Regulation Summit Forum (In-Vitro Diagnostic Session)” co-sponsored by China Association for Medical Devices Industry and Wuhan TACRO Technology Co., Ltd. ended on a successful note! TACRO has held five medical device registration verification and post-marketing regulation summit forums in Beijing, Shanghai, Kunming, Wuhan and other cities, attracting more than one thousand visitors and becoming the most popular registration verification related theme activity in the industry.
In-vitro diagnostic product, as a segment with the fastest grown and best momentum of development in the field of medical devices, has attracted the attention of hospitals, investors and companies. In the past two years, new regulations on diagnostic reagents have been frequently issued in China, and the regulatory situation has become more stringent. The in-vitro diagnostic reagent companies have experienced a number of common problems during product transformation. The outbreak of COVID-19 in 2020 brought COVID-19 testing reagent into public view, and many in-vitro diagnostic companies have get involved in the development of COVID-19 testing reagents. On the other hand, innovative technologies such as transformation, NGS, and digital PCR have become new hotspots in in-vitro diagnostics. For the purpose of helping medical device production and operation companies to raise their awareness of compliance and improve their quality management level, China Association for Medical Devices Industry together with TACRO specially organized this forum.
As a leading medical device technology transformation service platform in China, TACRO has always adhered to the bottom line of quality regulations and advocated returning the transformation of medical device innovation technology to regulatory regulations. Meanwhile, in recent years, TACRO has won the recognition and support of many companies and investment institutions by holding relevant activities all over the country in response to national strategies such as Healthy China and Prospering the Nation with Quality.
Address
Ms. Xu Shan, secretary general of China Association for Medical Devices Industry
Establishment of Reference Reagents for In-Vitro Diagnostic Reagents
Qu Shoufang, National Institutes for Food and Drug Control
Development and Registration of In-Vitro Diagnostic Reagents under the Guidance of Regulations
Cai Congli, Executive Vice President of TACRO Technology
Key Points and Countermeasures of Clinical Verification of In-Vitro Diagnostic Reagents
Fang Kun, Director of Clinical Division, TACRO Technology
Development of the Medical Device Industry in the Post-COVID-19 Era
Lin Senyong, Director of the Department of Medical Device Supervision, Shanghai Food and Drug Administration
Key Points and Innovations of Product Registration Based on NGS Technology
Zhou Meizhen, Director of Qualification Department of BGI
Research Progress of Digital PCR Technology and Its Application in In-Vitro Diagnosis
In-vitro diagnostic product, as a segment with the fastest grown and best momentum of development in the field of medical devices, has attracted the attention of hospitals, investors and companies. In the past two years, new regulations on diagnostic reagents have been frequently issued in China, and the regulatory situation has become more stringent. The in-vitro diagnostic reagent companies have experienced a number of common problems during product transformation. The outbreak of COVID-19 in 2020 brought COVID-19 testing reagent into public view, and many in-vitro diagnostic companies have get involved in the development of COVID-19 testing reagents. On the other hand, innovative technologies such as transformation, NGS, and digital PCR have become new hotspots in in-vitro diagnostics. For the purpose of helping medical device production and operation companies to raise their awareness of compliance and improve their quality management level, China Association for Medical Devices Industry together with TACRO specially organized this forum.
As a leading medical device technology transformation service platform in China, TACRO has always adhered to the bottom line of quality regulations and advocated returning the transformation of medical device innovation technology to regulatory regulations. Meanwhile, in recent years, TACRO has won the recognition and support of many companies and investment institutions by holding relevant activities all over the country in response to national strategies such as Healthy China and Prospering the Nation with Quality.
Ms. Xu Shan, secretary general of China Association for Medical Devices Industry
Qu Shoufang, National Institutes for Food and Drug Control
Cai Congli, Executive Vice President of TACRO Technology
Fang Kun, Director of Clinical Division, TACRO Technology
Lin Senyong, Director of the Department of Medical Device Supervision, Shanghai Food and Drug Administration
Zhou Meizhen, Director of Qualification Department of BGI
Ban Guihong, Vice President of Sales, TargetingOne
