China Agent

As the agent of overseas medical device manufacturers in China, collect and sort out the clinical data after product launch, submit to NMPA regularly, and maintain regular communication with local drug administration.

Technical Documentation Preparation

Prepare and collect the technical documents necessary for NMPA Import Registration, such as,

- The Application Form

- Supporting Document

- List of Basic Requirements for Safety and Effectiveness of Medical Devices

- Summary Material

- Research Data - Product performance study

- Research Data - Bio-compatibility evaluation study

- Research Data - Study on sterilization/disinfection process

- Research Materials - Product expiration date and packaging studies

- Research Data - Pre-clinical Animal Studies

- Research materials - Software Research

- Manufacturing Information

- Clinical Evaluation Data

- Product Risk Analysis Data

- Product Technical Requirements

- Product Registration Inspection Report

- Label Sample of Product Specification and Minimum Sales Unit

- Declaration of Conformity

Translation

Translate the documents from English or Italian or Japanese into Chinese.

Test Item Tracking and Rectification

- Testing lab selection and test tracking

- Test non-conformance rectification

- Technical communication with the testing lab

Window for Communication with NMPA

- Documents submission

- Progress Tracking

- Technical Communication

- Problem Solving