Reposted from: Shangguan News

From November 27 to 30, the 27th Global Harmonization Working Party on Medical Devices (GHWP) convened in Pudong, bringing together more than 600 delegates from 25 countries and regions worldwide. The conference featured discussions and exchanges on pressing issues such as innovation in medical device development and international regulatory frameworks, with the aim of advancing global regulatory convergence, coordination, and mutual trust through the joint efforts of regulatory authorities and the industry. This initiative seeks to contribute expertise and momentum to enhancing the quality of medical devices globally and safeguarding public health rights. Lu Xuecheng, Vice District Mayor of Pudong New Area, attended the event and delivered a keynote address titled “Openness and Innovation: Driving High-Quality Development of the Medical Device Industry.”

It is reported that the GHWP, established in 1997, is one of the oldest and most widely represented international organizations in the global medical device sector. It currently serves as the world’s only international platform for regulatory‑related dialogue on medical devices, jointly convened by representatives of regulatory authorities and industry stakeholders, with membership spanning 33 countries and regions. During the annual meeting, the National Medical Products Administration of China and the Medical Device Authority of Malaysia signed a Memorandum of Understanding on Cooperation in the Field of Medical Devices, reaching consensus on further strengthening regulatory exchanges and cooperation between the two countries.

In recent years, Pudong has pooled its top talent and resources to accelerate breakthroughs in the biopharmaceutical sector, positioning it as one of the three leading and six core industries that boast the most distinctive features and competitive advantages.

Driven by technological innovation, the region is fostering a thriving industrial ecosystem. In 2022, Pudong’s biopharmaceutical sector achieved a total output value of RMB 66.5 billion, with an overall industry scale of approximately RMB 340 billion—accounting for roughly 40% of the city’s total. Leading companies such as Siemens and Roche have established their headquarters and innovation centers in Pudong, while pioneering firms like MicroPort and Lishengte, which boast proprietary intellectual property and world-class technologies, have also flocked to the area. As a result, a new development pattern has begun to take shape, characterized by mutual reinforcement between domestic and international dual circulation within the biopharmaceutical industry. Furthermore, the National Medical Products Administration has set up the Yangtze River Delta Sub‑Center for Drug and Medical Device Review and Inspection in Pudong, helping to accelerate and streamline relevant review and approval processes.

By leveraging institutional innovation as a breakthrough, the region has unleashed new momentum for industrial development. Between 2016 and 2022, a series of industry‑specific policies, including the “Several Measures of Pudong New Area to Promote High‑Quality Development of the Biopharmaceutical Industry through Industry–Medical Integration,” were successively introduced, establishing a policy framework that strongly supports corporate innovation. The “first‑to‑market,” “first‑to‑be‑approved,” and “first‑batch” effects have spurred the continuous emergence of new industries, business models, and operational paradigms. To date, Pudong has secured approval for 12 first‑time registrations of Class III innovative medical devices, accounting for nearly 50% of the city’s total. Moreover, two medical institutions in Pudong have had their self‑developed in‑vitro diagnostic reagent products included in the national pilot catalog.

Underpinned by service innovation, Pudong has fostered a favorable business environment. It has successively enacted 18 district-level regulations covering areas such as market access, intellectual property protection, and the biopharmaceutical sector, thereby overcoming bottlenecks in the development of the digital economy, emerging industries, and critical technologies. Pudong also took the lead nationwide in establishing the Pudong Branch of the National Center for Guidance on Responding to Overseas Intellectual Property Disputes, offering innovators an integrated “one-stop” service that encompasses expedited patent examination, rapid rights confirmation, and swift enforcement of IP rights. In addition, Pudong has advanced smart, online‑based approval processes under the “One-Stop Service” framework and provided streamlined talent‑related services, creating a world‑class innovation and entrepreneurship ecosystem that attracts global talent and enables them to fully realize their potential.

A relevant official from the Pudong New Area Administration for Market Regulation stated: “Going forward, we will further strengthen regulatory oversight and industry‑wide collaboration, and promote a scientific and efficient model for medical device regulation. By leveraging the advantages of industrial clusters, we will establish robust platforms for communication and exchange, support talent development, empower the leading zone’s industries, reinforce policy safeguards, and refine the ecosystem for technological innovation and industrial growth, thereby injecting boundless vitality into the high‑quality development of the biopharmaceutical sector.”