China (Mainland)

China Med Device, LLC, as part of Accel, provides regulatory. CRO and commercial one-stop solutions for medical device, IVD, CDx and combination products in China. Our NMPA regulatory service include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and PMS.

Our Commercialization services include market research, reimbursement, partnership strategy and distribution qualification.

As a qualified NMPA legal agent with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their needs to create a local entity in China.

Registration, Renewal & Modification

• Registration Strategy
• Pre-consultation with NMPA
• Registration, modification, renewal submission & communication
• PTR writing and onsite type testing support
• Software and cybersecurity documents writing 
• Innovation, priority and other green pathways.

Clinical Trial, CER & Overseas Clinical Data

• Clinical strategy
• CER writing
• Overseas clinical data feasibility evaluation, gap analysis and justification, submission and follow-up
• Complete local clinical trial implementation
• Clinical trial assessment
• Clinical trial protocol design
• Sample size determination
• Data management and statistical analysis
• Clinical study report

Quality Management System (QMS), Post Market Surveillance (PMS) & Overseas Inspection

• QMS assessment, design and implementation
• GMP and ISO 13485 QMS establishment
• Clean room complete solution
• Internal external audit preparation, gap analysis, mock inspections, etc.

China Hainan/GBA Special Policies

• Unapproved devices commercial launch in months instead of years
• Hainan Real-World Data/Study (RWD/S) Pilot Program to supplement the NMPA regular submission

For detailed information, please visit our China Website.