East Medical Technology (Suzhou) Co., Ltd.

As a leading professional service provider of medical devices CDMO + CRO in China, East Medical Group is committed to providing a series of professional services for high-quality medical device project compliance, such as system guidance, compliance development, engineering transformation, commissioned production, inspection and testing, clinical evaluation and registration consulting.

The first cross-group CDMO platform: in 2019, the Group completed the first one-stop industrialization service base- -Suzhou Base. As the Leading Talent Project (Gusu Talent) introduced by Suzhou Municipal Government, it has completed the breakthrough of zero new mode of registrant system in Jiangsu Province, and become the first cross-group CDMO platform in Jiangsu Province approved for the medical device production license.

First new industrialization service cluster: group has completed the base in Changsha, Wuxi base, Nanjing business center of the construction of the four wings, formed the three child platform (i. e., the whole process regulations service platform, research and development verification and rectification platform and the registrant trustee production platform) mainly complete business chain, set up the first domestic new industrialization service cluster. At present, the group has more than 10,000 ㎡ active production line for ISO13485 system certification, 100,000 level clean workshop and high-end medical equipment production workshop (10,000 local level), successfully passed dozens of administrative license, certification, export certification and other on-site system assessment.

Domestic first self-check certified successful cases: at the same time, based on the regulations on administration of medical device registration self-check "the registration of the applicant can entrust entrusted production enterprises to carry out the self-check", in 2022, the group submitted the first self-check report, through the Jiangsu drug administration technical review and field system audit, became the first domestic use self-test report certificate of registration service platform, let entrust east medical innovation enterprise enjoy the welfare of the head, accelerate the project rapid listing process.

In addition, the group has also completed the first entrusted production case of three types of high-end medical devices in China and many successful cases such as the localization of imported devices.