RA Strategy & Consulting

China medical device/In-Vitro Diagnostic (IVD) regulations are ever-changing with increasing complexity. Our integrated and seasoned team can help you develop a customized RA strategy and deal with complex regulatory challenges. Our team excels in three critical areas: technical, clinical, and regulatory.

China RA Strategy & Consulting

By helping 250+ of manufacturers through this process, China Med Device team has established best practices that encourage collaboration, reduce snafus, and expedite registration speed.

Identify NMPA Classification and Registration Composition Units

The very first step for your China registration is to identify your NMPA classification and registration composition units. China’s NMPA classification is really different from the U.S. FDA. A Class I product in FDA could be Class II or even Class III in China. China Med Device team can help you complete the initial assessment and identify the NMPA classification and determine reasonable registration composition units, which will be fundamental for the whole China registration roadmap.

Design Phase Consultation

China Med Device team understands the complexity and difference between the regulations in different countries. To accelerate your China entry, we can provide product change suggestions during the early design phase to meet China’s regulatory technical requirements, assist to build China local type testing fixture if needed in China to save time and cost, etc.

Estimate Registration Costs & Timeline

China Med Device maintains local experts who fully grasp how to work within the Chinese system. According to your classification and registration units, China Med Device will help you generate a complete registration plan by indicating timeline, a milestone as well as the budget plan.

Provide Reference NMPA Regulations and Materials

China NMPA has released thousands of new regulations in the past few years. China Med Device can help you keep up with the rapid changes and updates, navigate and provide the reference NMPA regulations, guidelines, and standards that are relevant to your products.

We also provide multiple information channels for NMPA updates such as monthly newsletters, webinars, white papers, etc. Please click here to opt-in.