For medical device companies entering China
Regulatory consulting and translation for MedTech entering China
Two services, one team. Our consultants prepare the clinical evidence NMPA reviewers assess. Our translators turn your technical file into Chinese that meets the requirements.
Service line 1
Regulatory Consulting
Clinical evaluation, evidence analysis, NMPA support and manuscript review.
- Clinical evaluation and evidence gap analysis
- Systematic literature review and SOTA analysis
- NMPA market access: use of FDA and EU data, deficiency responses
- Regulatory advice with our partner Best-Road (Beijing)
- Extended service: SCI manuscript review and editing
Service line 2
Translation & Interpretation
Regulatory, business and certified translation, plus interpreters for meetings and events.
- Registration documents into Chinese: PTR, V&V reports, risk management files
- Clinical trial documents: protocols, CRFs, informed consent forms
- Business documents
- Consecutive and simultaneous interpretation
- Extended service: certified personal document translation (NZSTI, NAATI)
Trusted by
Since 1999Offices in Auckland and BeijingMedical devices our main fieldEvery project reviewed by a second linguist
Insights
Professional insights from our project work
Find out more about our professional insights on regulatory affairs, clinical evaluation, manuscript review and medical translation.
Answering an NMPA request for a representativeness argument
How we built a complete chain of reasoning for an indication expansion.
Four manuscripts, the same three logic failures
Structural problems that reviewers find and sentence-level editing misses.
AI interpretation is here. Does it solve cross-border communication?
The hardest barrier in China–West projects is two ways of working.
Free white paper
NMPA Clinical Evaluation Pathways
For overseas medical device manufacturers: the three clinical evaluation routes, a decision path for choosing between them, and the rules in China, Australia and New Zealand compared.
Need clinical evaluation support for NMPA, or regulatory documents translated?
Send us what you have and your deadline. We will reply with a quote.