Client names are under NDA. Everything else — device category, classification, regulatory pathway and current stage — is here.
Registrant company names and registration certificate numbers are covered by confidentiality agreements with our clients and are not published. What is published below — device category, classification, regulatory pathway and stage — is enough to tell you whether we have done work like yours. An itemised list with certificate numbers can be shared under NDA.
32 products currently in contract R&D and manufacturing. Registration certificates and filings obtained on behalf of registrants to date cover the following:
One project in execution, four in the pipeline. Status as of the most recent project review; pipeline projects have not yet commenced and are subject to change.
If your situation resembles any row above, the Entering China page sets out which regulatory pathway applies and what each one requires.
22 partnerships with tertiary hospitals and research institutes. Under these arrangements the hospital conducts compliant in-house R&D on its device innovations, and the platform takes on market access, sample production and scale-up once the concept is proven. Named partners are listed on the Partners page.