11th China Medical Device Regulatory Forum (CIMDR)

2020-11-18 | Beijing, South China

1.       Background

The China International Medical Device Regulatory Forum (CIMDR) is an annual event to bring the China National Medical Product Administration (NMPA), international regulators and Regulatory Affairs (RA) experts of medical device manufacturers together, to discuss and harmonise regulatory developments in China and the world. About 1600 delegates participated.

2.       Plenary Meeting

NMPA officials reported about their extraordinary efforts to approve medical devices used for the fight against COVID-19 in a very short time, in one example a test kit was approved within four days. Talking about strategic development, China has a huge number of medical device manufacturers (2019: 18070), but only very few internationally competitive companies. The NMPA wants to improve the regulatory system to contribute to the growth of the industry. The Centre for Medical Device Evaluation (CMDE) under the NMPA presented a 10-year plan 2021-2030 to develop their organsation into a world class centre for device evaluation. China is increasing international cooperation, the Vice-Chair of the Asian Harmonisation Working Party (AHWP) and two working group chair-persons are delegated by the Chinese NMPA.

Non-Chinese regulators reported on development of their national legal systems, including the lessons learnt from the sudden challenge by COVID-19. While countries like Saudi-Arabia presented via video, unfortunately the European Union was not among the speakers, mainly due to their workload in preparing implementation MDR/IVDR.

The Chairman of the China Medical Device Industry Technology Innovation Alliance gave the most critical report of the status of the Chinese medical device industry. Only seven Chinese medical device manufacturers are about the world top 100, the Chinese industry is still far behind developed countries in terms of R&D investment, innovation capability and quality. He appealed on the industry to change its mindset to become successful on this fast growing market.

3.       Sub-Fora

The sub-fora provide platforms for government officials and industry representatives a platform to discuss new developments and arising challenges. It is also a chance for the industry to directly present their stance on unsolved issues directly to the responsible officers.

4.       Parallel Fora

Two parallel fora were held during the conference:

In the 2^nd Forum on Development of Regulatory Affairs Professionals, officers from the NMPA and industry delegates discussed how to develop strong RA-teams in the industry.

The 2^nd Medical Device Managers 50 Forum (MD50) brings senior executives of the main industry players and government officials together, giving them a forum to discuss major challenges for the industry. High-level managers of Chinese companies are participating in increasing numbers.