Medical Device Clinical Trial Management in China

China’s State Food and Drug Administration (SFDA) requires manufacturers of some higher-risk devices to conduct clinical trials in China. Setting up clinical trials in the Chinese market can take serious effort. Managing compliance with (SFDA) regulations as well as recruitment, facilities, study designs and personnel issues requires considerable time and resources.

Medical device and clinical trial regulations in China have undergone significant changes in the last several years. In order to successfully establish and carry out medical device clinical trials in the Chinese market, you must ensure that these requirements are addressed.

Emergo Group offers full Clinical Research Organization (CRO) services in China, and has the experience to support all aspects of your medical device clinical trial strategy in China. Our Beijing office also keeps up with all changes to SFDA regulations, ensuring that all CRO services we provide are fully compliant with current laws.

As a medical device CRO in China, our comprehensive clinical trial management services include the following:

Medical device clinical trial strategy and study design

Evaluation of clinical pathways
Preclinical assessments
Study design and subject selection

Clinical trial management for medical devices

Site and investigator selection
Enrollment strategies
Clinical trial execution

Post-market clinical trial support

Post-market surveillance data analysis
Reimbursement strategy and management
Clinical studies for medical devices with design changes

Emergo Group’s China CRO services provide total assurance of your intellectual property protection, as well as full support for quality management and Good Clinical Practices. Our services include study protocol design and consultation, medical translations, source document management and report form development, as well as data management and clinical reporting.