CHINA NATIONAL MEDICAL PRODUCTS ADMINISTRATION（NMPA）MEDICAL DEVICE REGISTRATION SERVICE

CHINA NATIONAL MEDICAL PRODUCTS ADMINISTRATION（NMPA）MEDICAL DEVICE REGISTRATION SERVICE

Cosmos Biomed has established a long-term strategic partnership with China local CRO. The differentiation of China’s NMPA registration process and international regulations has been deterred by manufacturers in various countries. We hope to break the lengthy application time, and the well-planned test consultants and experienced China regulation enforcement teams will jointly plan and perfect the evidence collection plan. Through transparent and compliance suggestions, customers will be able to grasp the evidence and test dynamics in real time. Clinical trial planning and clinical trial exemption assessment are our strengths. Smooth communication is our advantage. Through our consulting services, you can confidently expand the Greater China market and establish a foothold in Asia.

Service Portfolio

 

CHINA NMPA

  1. Local/Import medical device China NMPA registration
  2. China Medical device Animal study planning and clinical trial exemption
  3. China NMPA medical device registration and usability evaluation
    Device technical requirement consulting service
    Device registration testing follow up service
    Device registration documentation and writing service
    Device gap compensation consulting service
    Expert review committee communication
  4. China NMPA clinical trial studying service
    Clinical trial protocol and report medical writing
    Clinical trial management
    Clinical trial monitoring
    Clinical trial data management
    Clinical trial statistical analysis
    Auditing and training program
    Clinical trial data sampling analytic system
    Clinical evaluation report writing