On December 4, 2023, the State Drug Administration (SDA) unveiled an updated Guideline for Medical Device Business Quality Management, effective from July 1, 2024. This revision emphasizes digital transformation and intelligence, enhancing supply chain efficiency and bolstering product quality and safety. It underscores the pursuit of industry-wide high-quality growth. The updated edition of the Guideline for Medical Device Business Quality Management introduces the requirements for “Unique Identification of Medical Devices” and “Traceability”. This implementation of the latest UDI policy, which specifically targets Class II medical devices starting from June 1, 2024, has had a significant influence on related enterprises. It has had a profound impact on businesses operating in this sector.

With the ongoing progress of medical device localization, renowned foreign brands are actively pursuing partnerships with local entities. Suppliers now face intensified competition and must strive for differentiation and increased competitiveness. Adhering to regulatory standards is a fundamental aspect of boosting competitiveness within this dynamic industry.

In addition to foreign companies steadfastly pursuing localization, domestic brands are also continuously exploring ways to break the monopoly of foreign investors. This has sparked a domestic innovation boom, prompting the government to introduce various policies to encourage innovation and expedite the listing of innovative medical devices. At the end of 2023, the State Medical Insurance Bureau issued a Response Letter to Proposal No. 02870 (Social Management No. 217) of the First Session of the 14th National Committee of the Chinese People’s Political Consultative Conference, which supports the exemption of innovative medical devices from DRG and fully considers the application of new technologies and devices in the reform of the DRG medical insurance payment method.

The innovation of medical devices is closely tied to the advancement of artificial intelligence. However, artificial intelligence also presents numerous challenges, such as data security and user privacy. On April 12, 2024, the Beijing Municipal Drug Administration issued the Inspection Guidelines of Beijing Municipal Quality Management Standard for the Production of Artificial Intelligence Medical Devices, marking the initial efforts toward ensuring compliance in the production and quality management of artificial intelligence medical devices. It is crucial to implement proper regulations to oversee and protect the healthy advancement of AI technology.

Taking a global perspective, the U.S. FDA has significantly fostered the progress of innovative medical devices since the inception of the “breakthrough device” program in 2018. In 2023, several domestically manufactured innovative medical devices received FDA breakthrough designations.

The rise of innovative products and technologies has led to a rapidly evolving market, prompting the proposal of agile regulation to adapt to these swift changes. Agile regulation not only emphasizes quicker responses, but also calls for a reconsideration and restructuring of the management process. Flexibility, efficiency, and transparency are fundamental to agile regulation, but how is it put into practice? What are the practical advantages for organizations?

This conference will bring authorities from relevant departments together to discuss the regulations mentioned above, aiming to assist enterprises in clarifying their future development direction and providing guidance suggestions.