Regulatory Consulting
Clinical evidence for your NMPA submission
Most devices registered in China need a clinical evaluation that meets NMPA requirements. Your existing evidence from FDA, EU MDR or TGA submissions is a starting point, not a finished dossier. We restructure it into the argument NMPA reviewers expect, and we work alongside your regulatory affairs team or Chinese agent.
What we do
Clinical evaluation for NMPA
We build China-compliant clinical evaluation documents from your overseas evidence: comparison with similar devices, literature data and clinical data. We also review clinical evaluation reports drafted by your own team before submission.
NMPA deficiency responses
When NMPA issues a deficiency notice on clinical evaluation, we analyse each point, identify which need new evidence and which need a clearer argument, and draft responses that cite your IFU, labelling and test reports. Recent work includes a representativeness argument for the indication expansion of a cardiovascular surgical device.
Literature search and review
Systematic searches in PubMed, Embase and Wanfang, screening against predefined criteria, and a written review: state of the art, competitor and gap analysis, or evidence summaries by device category. Recent reviews have analysed between 150 and 171 publications per product.
Clinical evaluation for other markets
Clinical evaluation and literature work for EU MDR, US FDA, and Australian and New Zealand submissions.
Scientific manuscript review
For clinical researchers preparing SCI submissions: a review of argument structure, statistical boundaries and journal expectations before peer review, followed by language editing and support with reviewer responses.
Regulatory advice
Advice on NMPA clinical evaluation pathways and evidence requirements, provided together with our regulatory affairs partner in Beijing, Best-Road (Beijing).
How a consulting project runs
- Scope. We review your device, intended use and existing evidence, then propose scope, timeline and fee.
- Plan. We agree the search strategy, evaluation route and report outline with you before writing starts.
- Writing and review. Every statement is checked against its cited source. A second person reviews every report.
- Delivery. Report in Word and PDF, full reference list, and the reference library in EndNote format. We support revisions until submission.
Why companies work with us
Evidence you can check
Every statement cites its source, so your team and the reviewer can verify it.
Both sides of the submission
We have translated registration files for international manufacturers for years, so we know what NMPA reviewers look for in the Chinese text.
Project control
One project manager per project, a documented scope and on-time delivery under quality-managed workflows.
Questions
Do you submit to NMPA for us?
No. We prepare the clinical evidence and responses. Submission stays with your regulatory team or Chinese legal agent.
Can you work from our existing CER?
Yes. An EU MDR or FDA clinical evaluation is usually the main input. We identify what NMPA needs in addition and restructure the argument.
Planning an NMPA submission?
Tell us about your device and timeline. We will propose a scope and fee.