Clinical Trial and Evaluation

Clinical trial to be conducted in China is essentially required for many class II and almost all of class III devices, unless it is enlisted in the Clinical Trial Exemption Catalog (CTEC). In some circumstances, a class II or Class III device may go through a predicate equivalence approach even though it is not included in CTEC, and then clinical evaluation report based on existing clinical data of the predicate should be submitted in stead of in-China clinical trial to be conducted. 

BioHan Consulting will help you to assess the clinical pathway, prepare the clinical evaluation report, and to plan, design, manage and/or conduct clinical trials in China if necessary. Also importantly, we help to identify and negotiate with clinical centers, apply for approval from Ethic Review Committee. Our expertise include

• Expertise on ISO 14971 Risk Management and standards compliance
• Experience on CFDA GCP and ISO 14155 standard compliance 
• Knowledge on GB16886 (ISO10993) and product particular performance standards
• CFDA clinical trial and evaluation guidance, as well as product-particular clinical trials guidance