CHEN
Deda MedCheck
(Global Medical Device Search)

01
Annual Consulting
Home > Service Items > International > Annual Consulting > Domestic & Overseas Regulatory Consultation & Interpretation
Domestic & Overseas Regulatory Consultation & Interpretation
On-site Coaching
Mock Audit
Domestic & Overseas Regulatory Training
Corporate Compliance Consultancy
Global Market Access Route Planning for Products
Process Validation Optimization Advice

Domestic & Overseas Regulatory Consultation & Interpretation

Provide Regulatory Change Early Warning & Impact Analysis
  • Track regulatory updates of target markets including NMPA, FDA, CE and ASEAN in real time.
Establish & Continuously Update The Regulatory Standard Inventory
  • Assist in identifying applicable national standards (GB), industrial standards (YY) and international standards (ISO/IEC) for products.
Interpret The Latest Review Requirements and Guiding Principles
  • Explain relevant provisions on registration application, clinical evaluation and GMP system tailored to specific products.
Interpretation of Access Regulations and Compliance Gap Analysis
  • Interpret access regulations and analyze compliance gaps for import registration and overseas registration.
Free Consultation