BioHan Biotechnology Consulting (Beijing) Co. Ltd. (BioHan Consulting) was founded in 2012 China to provide regulatory affairs, quality management and commercial services to medical device companies, which need help in product pre-market approval, post-market compliance, marketing strategy and distribution in China. Dr. Davey Han (profile), the founder has more than 25 years experience in these areas. As a leader of medical device industry associations, he has involved actively in development and implementation process of almost all medical device policy & regulations since 1997. With a rich experienced team, BioHan Consulting is able to provide the services in medical device and IVDs as follows:

1)    Regulatory/clinical pathway & strategy

2)    NMPA submissions and technical file composition

3)    Management for NMPA RegistrationTesting

4)    Clinical Trials and Evaluation

5)    NMPA GMP and Manufacturing License

6)    Post-market compliance and Legal Agent

7)    Assistance on Pre-market Approval for Foreign Markets

8)    Policy Investigation and Reimbersement Application,

9)    Marketing Strategy, Bidding, Sales/Distribution Services

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