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Category: Registration / Filling

NMPA Medical Device Registration & Clinical Trial Process

July 8, 2020

Operation Specification for Record Filing of Medical Device Master Files

January 3, 2019

Record Filing Requirement of Medical Device Master Files

January 3, 2019

Guideline for Record Filing of Medical Device Master Files (Draft)

January 3, 2019

Announcement on Record Filling of Medical Device Master Files

January 3, 2019

Innovation Device Approval Procedure

November 5, 2018

Unique Device Identification (UDI) Implementation Plan (Draft)

August 22, 2018

Using Chinese Name for Registrant or File Submitter of Imported Medical Devices

November 2, 2017

Regulation on Instructions for Use and Labels of Medical Devices

July 30, 2014

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