Overview:

On March 31, China NMPA and NHC released an updated version of Good Clinical Practice (GCP) regulation for Medical Devices (announcement 28, 2022), that will take effect on May 1, 2022. The new GCP regulation is an updated version of the previous version that was originally published in 2016.

INTRODUCTION

The new GCP regulation is more aligned with the latest international standards (IMDRF MDCE WG/N57 FINAL:2019, ISO 14155:2020, ISO 20916:2019), and its objective is to encourage the conduct of global and foreign clinical studies in China.

The new GCP regulation covers the whole process of medical device and in-vitro diagnostic clinical trials, including the design, implementation, monitoring, management, data collection, data recording and archiving, data preservation, and analysis, adverse event reporting and responsibilities of the investigators and sponsors.

Understand a little about this Clinical Trial Process

General Provisions & Ethisc Committee

  • It clarifies the legal basis and scope of the GCP requirements and adds in-vitro medical devices to the guideline for the first time.
  • It provides the requirements for the ethical committee review process.

Clinical trial institution for medical devices and Investigators:

  • It clarifies the responsibilities of the clinical trial institution involved in the conduct of clinical trials for medical devices.
  • It clarifies the responsibilities of the investigators during the conduct of clinical trials in china including reporting adverse event during the clinical trial.

Sponsors

  •  It clarifies the responsibilities of the sponsors during the conduct of clinical trials in china.

Clinical Trial Protocols and Trial Reports, Multicenter Clinical Trials and Recording requirements:

  • It provides the requirements for clinical trial protocols and reports.
  • It clarifies the requirements for conducting global clinical trials including china and also simplifies the process and reduces the number of site clinical sites needed for the completion of the trial.
  • It provides the requirements for clinical trial records, and clinical data collection. And also Adjust safety reporting procedure.
  • It provides definitions of the main clinical terms used in this regulation.

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 For the link, click here (Contact Our Team in China).

GCP regulation for medical devices in China, link here in chinese.

GRP Whitepaper: Clinical Trial Application in China

In China, a Clinical Trial Application (CTA) should be submitted to the National Medical Products Administration (NMPA), to request the authorization to administer an Investigational Drug to humans

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.

GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations. 

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