Service Introduction

一、Jiushun Enterprise Management Technology Service Co., LTD. provides one-stop service of In-Vitro Diagnostic registration for you:

      （一）Intended product technical requirements

      （二）Registration testing report

      （三）Clinical trials

      （四）Quality management system evaluation report

      （五）Registration certificate for product

      （六）Manufacturing license

二、List of application documents:

      （一）List of application documents for domestic IVD

      1、Application form of domestic IVD registration;

      2、Sampling documents and records；

      3、Summary data

      4、Package insert

      5、Intended product technical requirements;

      6、Research data for major raw materials;　 

      7、The research data for main production technology and reaction system;

      8、Analysis of performance evaluation data;

      9、Determination of reference value (reference range);

      10、Stability research data;　　

      11、Clinical trials data

      12、Production and self-test records;　　

      13、Sample of packaging and labeling;　　

      14、Reference material and data.

      （二）、List of application documents for overseas IVD

      1、Overseas IVD registration application form;

      2、Designated agent’s letter of entrustment /commitment, business license or institutional registration certificate (photocopy);

      3、Summary data （Documents in Original and Chinese）;

      4、Package insert;

      5、Intended product technical requirements;

      6、Research data for major raw materials（Documents in Original and Chinese）;　

      7、The research data for main production technology and reaction system（Documents in Original and Chinese）;

      8、Analysis of performance evaluation data（Documents in Original and Chinese）;

      9、Determination of reference value (reference range) （Documents in Original and Chinese）;

      10、Stability research data（Documents in Original and Chinese）;　　

      11、Clinical trials data

      12、Production and self-test records;

      13、Sample of packaging and labeling;

      14、Reference material and data.