BioHan Biotechnology Consulting (Beijing) Co. Ltd. (BioHan Consulting) was founded in China to provide regulatory, quality and commercial services to medical device companies, which face key challenges and need help in their product pre-market approval and post-market compliance for China market. Dr. Davey Han (profile), the founder of BioHan Consulting has more than 25 year experience in health policy, regulatory affairs and quality management. As a leader or representative of industry associations, he has involved actively in the development and change process of almost all CFDA medical device regulations/policies since 1997. With an expert team and rich experience, BioHan Consulting is able to provide the services in medical device and IVDs, including:

1)    Regulatory pathway & strategy

2)    CFDA submissions and technical file composition

3)    Management for CFDA RegistrationTesting

4)    Clinical Trials and Evaluation

5)    CFDA GMP and Manufacturing License

6)    Post-market compliance and Regulatory Agent

7)    Assistance on Pre-market Approval for Foreign Markets

8)    Policy & Regulation Investigation and Report,

9)    Market Research and Intelligence

Please find more details for each of the services on particular pages