Eight Clinical Evaluation related Guidelines Call for Comments

China NMPA released eight draft clinical guidelines for urgent feedback to support the new overarching State Order 739, the “Regulation for Medical Device Administration and Supervision”. It covers the full spectrum of clinical requirements for China NMPA submissions. All feedback needs to be submitted by May 30, 2021.

Please see below for the eight specific names. The last five guidelines are released for the first time.

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)
• 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)

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

What Do these Guidelines Say?

Medical Device Clinical Trial Quality Management Measures (draft)

The older Clinical Trial Quality Management Measures, the China GCP, was issued in March 2016. The newly published GCP has the major updates as follows:

1. Adjust the overall frame from 96 articles in 11 Chapters to 66 in 9 Chapters.
2. Integrate IVD into NEW GCP NMPA Clinical Pathways.
3. Clarify responsibilities of the relevant parties in clinical trials of medical devices.
4. Adjust safety information reporting process.
5. Simplify optimization requirements.
6. Reflect the latest requirements of international regulatory system.

For the comprehensive review of the “Medical Device Clinical Trial Quality Management Measures (draft)”, please click HERE.

Guideline for Clinical Evaluation of Medical Devices (draft)

1. Definitions for some terms are clearer: clinical investigation, clinical data, clinical evaluation, clinical evidence,
2. Clinical investigation includes feasibility trials, trials for marketing approval, and trials after marketing approval.
3. Clinical data is more versatile:
   • Pre- and post-market clinical trial results of the device in question
   • Pre- and post-market clinical trial results of the comparable device, or other research results published in the scientific literature.
   • Published and / or unpublished clinical experience reports of device in question or comparable device.
   • Clinical experience data from other sources: such as registry study, adverse event database and medical record data
4. Clinical evaluation is conducted by the applicant to demonstrate the compliance of the product with the basic principles of safety and performance. Clinical evaluation report should be issued, which can be provided to regulatory authorities for review.
5. Clinical evaluation needs to be carried out continuously. After the product is launched, the applicant needs to carry out routine monitoring on the safety, clinical performance and / or effectiveness information of the product and re-evaluate the risk and benefit according to the updated information.
6. The input of clinical evaluation mainly comes from clinical trial reports, clinical literature, and clinical experience. The clinical data and evidence need to demonstrate the product’s compliance with the basic principles of safety and efficacy.
7. The purpose of clinical evaluation is to prove that the risks associated with the use of products are acceptable compared with the benefits of patients and can protect the health and safety of patients to a higher degree. Therefore, clinical evaluation should be cross referenced with risk management documents.
8. Clinical evaluation should be carried out continuously throughout the whole life cycle of medical devices. In the design and development stage, clinical evaluation needs to determine the clinical data required for premarketing product evaluation, determine whether clinical trials need to be carried out and whether the clinical endpoints need to be observed. After the product is released to the market, continuous updating of the safety, clinical performance and / or effectiveness information of the product, and periodic clinical evaluation is needed. The above updated information will be used as the input of risk management and may lead to the changes in risk assessment, clinical evidence, instructions for use and post marketing activities.
9. The applicants are required to implement and maintain a post marketing monitoring plan to routinely monitor the safety, clinical performance and / or effectiveness of products as part of the quality management system. The scope and nature of post marketing monitoring should be compatible with the product and its application scope. The applicants need to use the data generated by the monitoring plan (such as adverse event reports, post marketing clinical trials, clinical literature data, etc.) to carry out clinical evaluation, periodically review the performance, safety, and risk benefit assessment of products, and update clinical evidence.

Guiding Principles for Demonstration of Medical Device Equivalence (draft)

1. Comparable device selection
2. Equivalence evaluation of intended use
3. Technical equivalence evaluation
4. Biological equivalence evaluation

Guideline for Decision on Conducting Clinical Trial of Medical Devices (draft)

1. Whether conducting a clinical trial or not is necessary
2. Manufacturers are encouraged to use the most effective way to prove the safety and performance of medical devices, which are demonstrated by the clinical evidence and other design verification and confirmation documents, device descriptions, and instructions, etc.
3. In principle, clinical trial is mandatory for high-risk Class III device, but in 3 scenarios the clinical trial can be exempted: a) predicate is marketed in China, and the non-clinical & clinical data, and overseas data for device in question can prove the safety and efficacy acceptable; b) predicate is not marketed in China, but the non-clinical, clinical trial and overseas clinical data for device in question can prove the safety and efficacy is acceptable; c) overseas clinical data acceptance pathway.
4. If the device in question is New Medical Device, clinical trial is necessary. New Medical Device means that, compared with those that have been approved in China, the medical devices have significant differences in scope of application, technical characteristics, and/or biological characteristics. But in 3 scenarios the clinical trial can be exempted: a) non-clinical data is enough to prove the safety and efficacy; b) overseas data pathway; c) predicate product overseas clinical data

For clinical evaluation decision tree provided by NMPA, please email info@ChinaMedDevice.com.