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SCU Has Got Approved for APEC Medical Devices Regulatory Science Center of Excellence

Date:Jun 19, 2020

On the evening of June 15, the Regulatory Harmonization Steering Committee (RHSC) of the Asia-Pacific Economic Cooperation (APEC) approved the APEC pilot workshop program of Medical Devices Regulatory Science Center of Excellence at Sichuan University during its global conference call. This will be the first Medical Devices Regulatory Science Center of Excellence in China. 78 experts and officials from 18 APEC member economies, 15 universities and research institutions, seven international pharmaceutical industry organizations, and five international organizations such as WHO, ICH, IMDRF attended the conference. At the conference, the chairman of RHSC introduced SCU’s report on the pilot workshop program of the Center of Excellence. He pointed out that Sichuan University has done an amazing job and set records in individual indexes of RHSC. The approval of SCU’s application took less than one year.

The approval of the establishment of this center indicates that SCU will play a leading role in the scientific development of medical devices supervision, regulatory capacity building, coordination and cooperation in China and the Asia-Pacific region. It is of great significance in boosting China's  influence in the field of medical devices, and promoting China's medical device industry to the world, and the countries of the “Belt and Road” initiative in particular.

In August 2019, Xingdong Zhang submitted, on behalf of Sichuan University, an application at the third APEC senior officials meeting in Puerto Waras, Chile. The application defense went well and SCU got approved for a pilot program. In December 2019, SCU successfully conducted the pilot workshop program of the APEC’s Medical Devices Regulatory Science Center of Excellence. The attendees included nearly 40 medical devices officials from 17 APEC member economies, such as the USA, Canada, Singapore, South Korea, Indonesia and Thailand. The training added to the supervision ability of the officials, enhanced their understanding of the coordination of medical device supervision and the global integration of medical devices. Meanwhile, the workshop demonstrated China's medical devices supervision ability to other APEC member economies and RHSC.

The center will vigorously accelerate the internationalization process of Sichuan University. Also, the establishment of the Center is conducive to the recognition of the Chinese medical device innovations by international medical device regulators. It will improve China’s capacity for innovation and R & D in medical devices, enable patients to use newer, safer and more effective medical devices as soon as possible, thus benefiting patients in the Asia-Pacific region and the world as well.

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