The 2022 General Meeting of the In Vitro Diagnosis (IVD) Branch of China Association for Medical Devices Industry (“Meeting”) was grandly held at the Nanchang International Expo Center on October 25, 2022. The Meeting was attended by the representatives of nearly 200 member units, chaired by Secretary General Chen Jun and covered by innomd.org.

So far, the IVD Branch has 195 member units and manages four functional groups to mainly conduct the following work: the annual general meeting, the preparation of the industry annual report, other industry meetings hosted and co-hosted, and speaking at various industry meetings and activities on behalf of the member units.

Fully promoting the branch’s development through the four functional groups
Mr. Zhu Yaoyi, Council President of the IVD Branch, gave opening words at the Meeting. He first expressed his sincere thanks to the China Association for Medical Devices Industry (“CAMDI”) for its active support and encouragement of the work of the Branch and to the member units for their support of and trust in the new council and said that the new council will continue to accomplish various tasks, provide service support for member units and make new contributions to IVD development in China.

Additional vice council president units and council member units were also elected at the Meeting, with the newly elected council member units including New Industries Biomedical, Hybribio, Vazyme and Burning Rock and the newly elected vice council president units including Ortho and MGI.

Then, representatives from four companies, including Fosun Diagnostics, BSBE and BioSino, shared the work summaries of different functional groups, including the member group, medical insurance procurement group and industry-university-research group, in 2021. On behalf of the rotating chair, Tellgen, Mr. Yao Bei’er reported on the preparations of the 14th China In Vitro Diagnostic Industry Summit Forum, with the theme finalized after thorough discussions being Riding on the Momentum, Continuing the Resplendence.

Analyzing industry development, interpreting the report and sharing ideas about regulations

Mr. Zhu Yaoyi gave an in-depth interpretation of the Annual Report on the In Vitro Diagnostics Industry in China 2021 jointly prepared by the IVD Branch and the Medical Examination Industry Branch of National Association of Health Industry and Enterprise Management by elaborating on dimensions such as policy and environment, industry status and progress and opportunities and challenges.

Regarding policy and environment, Mr. Zhu Yaoyi said that there is strong policy support for the development of innovative medical devices and a series of policies at the national level have been successively introduced to deepen the review and approval and promote fast and convenient registration, therefore, the development of the in vitro diagnostic industry has increasingly shown a new situation in China.
Regarding opportunities and challenges, Mr. Zhu Yaoyi stated that the overall development of the medical industry is on the rise, the multi-child policy promotes eugenics examinations, and the state increases the investment in medical institution facilities construction and strengthens support for medical equipment industrialization. However, the industry is also faced with huge challenges due to uncertainties brought about by the pandemic, including the medical service price reform and changes in medical insurance payment methods, the impact of tendering and procurement, and inadequate innovation capabilities, thus, market competition will become more intense. Mr. Zhu Yaoyi put forward opinions on the development of the industry at the end of his speech, in the hope that more industry associations and enterprises will actively participate in policy consultation, jointly promote the efficient development of the industry and establish a coordination mechanism for industry self-regulation.
To make member enterprises gain a deeper understanding of the latest policies of the National Medical Products Administration of China, the IVD Branch also invited Mr. Huang Jie from the National Institutes for Food and Drug Control to share his Regulatory Requirements and Testing of In Vitro Diagnostic Reagents, in which Mr. Huang Jie further explained in detail the administrative measures for reagent registration and filing, diagnostic reagent inspection and testing and quality control technology standardization.

Taking product design and development as an example, Mr. Huang Jie explained that the development of innovative products such as gene sequencing products does not only involve the development process of the reagents but also the development and verification of the bioinformatics data analysis process and that due to the verification of testing results, the said development sometimes requires evidence-based data accumulation for a long time and needs to gradually improve the data in the clinical application process and update the bioinformatics data and analysis process in real time according to the progress of scientific research.

After the sharing of the speakers, Secretary General Chen Jun issued the certificates of the new council members and the participants took a group photo. With this, the Third General Meeting of the Second In Vitro Diagnosis (IVD) Branch of China Association for Medical Devices Industry came to a successful conclusion! See you next time!