Consulting ServicesEducation and TrainingMedical DevicesRegulatory Information Management

RA Strategy & Consulting


Booth: 432

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 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: 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 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.

Other product: CRO Services

Other product: IVD & CDx Expertise

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