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Eight Clinical Guidelines Published: from Clinical Trial, Clinical Exemption, to Evaluation Report and Same-Variety Comparison

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The NMPA issued eight draft guidelines to regulate the clinical pathways in May. Feedback needs to be submitted to the NMPA by May 30, 2021.

Complete List

  • Medical Device Clinical Trial Quality Management Measures (draft)
  • Guideline for Clinical Evaluation of Medical Devices (draft)
  • Guideline for Clinical Trials of In Vitro Diagnostic Reagents (draft)
  • Guiding Principles for Demonstration of Medical Device Equivalence (draft)
  • Guideline for Decision on Conducting Clinical Trial of Medical Devices (draft)
  • Guiding Principles for Clinical Evaluation Reports for Medical Device Registration and Application (draft)
  • Catalog of Medical Devices Exempted from Clinical Evaluation (draft)
  • Technical Guidelines for Methodological Comparison of In Vitro Diagnostic Reagents Exempt from Clinical Trial (draft)

The last five guidelines are released for the first time.

For English version of above documents, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.

New GCP Main Revisions

Grace Palma, CEO of China Med Device, LLC, summarizes the major differences of the two versions of the “Medical Device Clinical Trial Quality Management Measures”, the China GCP.

Adjust the overall frame

The NEW GCP is changed from 96 articles in 11 Chapters to 66 in 9 Chapters. The chapters of the revised draft are general principles, ethics committee, clinical trial institutions, investigators’ responsibilities, sponsor’s responsibilities, protocol and clinical study reports, multicenter clinical trials, recording requirements and terminology. The contents of the chapters in the 2016 edition of the GCP, including preparation before clinical trials, protection of subjects’ rights and interests, and management of investigational medical device, are classified into the responsibilities of all participants in clinical trials.

Integrate IVD into NEW GCP NMPA Clinical Pathways

This revision is suitable for the needs of IVD industry and supervision, and the quality management requirements of clinical study of IVD are included in the NEW GCP, which is consistent with the quality management requirements of clinical study of medical devices as a whole, reflecting the consistency of the concept and requirements of clinical trial quality management, and considering the special situation of clinical study implementation of in vitro diagnostic reagents, Some applicability clauses are put forward to enhance its operability.

Clarify responsibilities of the relevant parties in clinical trials of medical devices

The NEW GCP strengthens the responsibilities of all parties in clinical trials. First, the Main Body Responsibility of the sponsor is highlighted, the risk management concept is introduced, and the quality management system of the sponsor should cover the whole process of clinical trials of medical devices. Second, strengthen the responsibilities of clinical study institutions and investigators accepting the medical device study. Third, the supervision responsibility of the authorities is clearly defined.

Adjust safety information reporting process

The NEW GCP optimized the safety information reporting process. First, the “double report” is changed to “single report”. The sponsor shall report to the provincial regulatory authorities where the Sponsor is located. And the provincial regulatory authorities and the healthcare authorities in the place where the clinical study institution is located. Second, the scope of the report is determined as the serious adverse events related to the investigational medical devices. Third, the reporting time limit for death or life-threatening is within 7 days after the sponsor is informed, and the time limit for reporting non death or life-threatening and other potential serious safety risks is 15 days after the sponsor is informed.

Simplify optimization requirements

The NEW GCP combines the industrial demand and the actual supervision requirements to solve the problems that are more concentrated at present. The requirement that “clinical study of medical devices should be conducted in two or more clinical study sites of medical devices” was deleted, which solved the problem that some medical devices are difficult and need not carry out clinical trials in two clinical study institutions. The requirement of one year validity period of the Type Test Report was cancelled, which is more smooth for clinical trials conduction.

Reflect the latest requirements of international regulatory system

The NEW GCP implements the relevant contents of the International Coordination Document led by China. E.g., IMDRF MDCE WG/N57 FINAL:2019 “Clinical Trial” is absorbed, the concept of multi-regional clinical trials conducted in different countries or regions is introduced, which is favorite for the global innovative products to conduct clinical trials simultaneously in China. In the process of revision, the relevant contents of ISO 14155:2020 are fully referred, and the latest version of international standards is reflected in many parts of the text and terms.

If you have any questions about NMPA Clinical Pathways, feel free to contact us at info@ChinaMedDevice.com for more information.