RA Strategy & Consulting – 202006 Prototype

Registering medical devices and IVDs in China can be complex and difficult. Even if you have deep FDA and EU registration experience, meeting requirements under China NMPA can be challenging. Plus, you must deal with the vast differences in Chinese culture and language.

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

China RA Strategy & Consulting

Identify NMPA classification and registration composition units

The very first step for your China registration is identify your NMPA classification and registration composition units. China NMPA classification is really different from U.S. FDA. An 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 the 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 and 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.