NMPA REGISTRATION

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.

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

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

Testing lab selection and test tracking
Test non-conformance rectification
Technical communication with the testing lab

Daocuments submission
Progress Tracking
Technical Communication
Problem Solving

Technical Doc Preparation

Translation

Test Item Tracking & Rectification

Window for Communication with NMPA

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