These are the documents prospective registrants ask us for. We ask for an email so we can tell you when a version changes and route your enquiry to the right person — nothing else.
Email is required. Company and phone are optional, but they help us give you a more useful reply.
If you would rather talk to someone, email contact@seno.bio or call +86-571-28253702.
Licensed manufacturing scope, delivered device categories, the split of responsibility under the registrant system, how an engagement runs, and facilities.
Download PDF →The three regulatory routes, three questions that decide which one is yours, who does what, current cross-border projects, and the questions worth settling before you commit.
Download PDF →Certifications, manufacturing licences, inspection record, official designations — and an explicit list of what the document does not contain and why.
Download PDF →Related: Medical Device CDMO · Entering China · Credentials · Delivered Work