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
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.
Since 1999
Beijing, Auckland, Brisbane
BBM started in Beijing in 1999 and opened its Auckland office in 2012. Medical devices have been our main field for most of that time. In 2026 we added a client contact point in Brisbane.
Quality and project control
One project manager, two sets of eyes
Every project has one project manager, a documented scope and a second-person review before delivery.
Need clinical evaluation support for NMPA, or regulatory documents translated?
Send us what you have and your deadline. We will reply with a quote.