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 matches the national standards.
Service line 1
Regulatory Consulting
Clinical evaluation, literature reviews and regulatory advice for your China submission.
- Clinical evaluation for NMPA, built from your FDA, EU MDR or TGA evidence
- Systematic literature search and review
- NMPA deficiency analysis and responses
- Scientific manuscript review and editing
- Regulatory advice with our Beijing partner, Best-Road (Beijing)
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
- A bilingual XLIFF file with every delivery
- Business documents and certified personal documents (NZSTI, NAATI)
- Consecutive and simultaneous interpretation
Trusted by
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.
Have documents to translate, or need dossier preparation for NMPA submission?
Send us what you have and your deadline. We will reply with a quote.