European Chamber 1st Medical Device Forum - Enhancing Healthy China: Medical Device Supervision and Innovation and Development of the Industry Go back »

2019-12-24 | Beijing

European Chamber 1st Medical Device Forum - Enhancing Healthy China: Medical Device Supervision and Innovation and Development of the Industry

The European Chamber 1st Medical Device Forum took place in Beijing on 18th December, attended by over 150 guests. Secretary General Adam Dunnett welcomed all to the event, before giving a general overview of the Chamber and its Healthcare Equipment Working Group. Madeleine Kihlberg, First Counsellor of the Delegation of the European Union to China, delivered some opening remarks, briefly outlining the cooperation between the European Union and China and how it could fit with the strategic plan Health China 2030. Director General Lanming Wang from the National Medical Products Administration (NMPA) made a keynote speech, in which he emphasised the enhancement of regulatory knowledge and skills, and called for future cooperation.


The theme of the forum’s plenary session was ‘Enhancing Healthy China: Medical Device Supervision and Innovation and Development’. In this session, a number of distinguished speakers gave presentations on various topics as follows:

1)     NMPA: the history of and progress in reform of the medical device review and approval system, including: special approval channels for innovative medical devices and those designed for special treatment; unique device identification (UDI); reform of clinical trial supervision and administration; Electronic Regulated Product Submission (eRPS); marketing authorisation holder (MAH) reform; international cooperation; and regulatory science;

2)     National Institutes for Drug and Food Control: progress in the standardisation of artificial intelligence medical devices, including industrial development, global regulatory framework, the outlook for 2020, and issues related to ethics;

3)     General Administration of Customs: setting up new benchmarks for the quality and safety of imported medical devices, including regulatory documentations, customs legal enforcement, and commodity inspection;

4)     National Health Commission: promoting the development of a hierarchical diagnosis and treatment system, including regulatory context, work-in-progress, experience from local practice, and future outlook;

5)     Academics: international experiences with diagnostic-related groups (DRGs), including DRG designs, potential shortcomings, outcomes and changes in hospital management; and the MAH regime for medical device, including general overview, benefits for industry development, and problems encountered at the stage of implementation.


The afternoon session began with a presentation by Professor Zhenzhong Zhang from China Health Economics on the design and practices of the DRG-based payment system pilot reform, which included aspects such as why the DRG system is needed, its impact on hospital management, its design principles, and local practices.

This was followed by a panel discussion on medical device administration under the wave of reform. Panellists analysed:

1)     technical review of medical device, including reform progress and future work plan;

2)     hospital management reform, such as adverse event reporting, clinical trial management and changes after the implementation of UDI;

3)     medical device standards, international cooperation and work related to medical device standardisation;

4)     on-site audit medical device quality management system, e.g. regulatory context, procedure, issues encountered in practices and corresponding measures;

5)     corporations’ views on medical device industry supervision and market access policies, including approaches to medical device regulatory framework, cooperation with the administration and importance of improving quality of work.

The second panel covered a wider range of topics related to opportunities and challenges of medical device regulatory environment, for instance;

1)     innovation landscape of global collaboration, e.g. medical device market of the European Union (EU) and related business opportunities;

2)     EU market access, including regulations for medical devices and supports from notified bodies;

3)     digital health, including deep learning, data localisation and regulatory framework;

4)     intellectual property protection for medical devices, especially issues related to innovative medical devices.


The quality of the presentations and speeches throughout the day were highly praised by participants of the forum.

Members and other stakeholders can expect the European Chamber Medical Device Forum to be hold annually from this year on.


For more information please contact

Jessica Yuan

Dafei Wu