China: Notice on the matters of Implementing the Good Clinical Trials Practice for Medical Devices

ARQon
Jun 24, 2022
3 min read

The Medical Device Good Clinical Practice (GCP) has been newly revised and announced by the National Medical Products Administration (NMPA) on 31 March 2022 and has since replaced the previous version (effective as of 1 June 2016) on 1 May 2022. It covers the entire process of the medical device clinical trials, including design, implementation, supervision, inspection, data collection, recording, preservation, analysis, summary, and reporting. The changes are made to adapt to the latest international regulatory system.

There are six published attachment documents related to clinical trials:

Medical devices clinical trial plan template
Medical devices clinical trial report template
In vitro diagnostic reagent clinical trial plan template
In vitro diagnostic reagent clinical trial report template
Adverse event reporting form for medical devices/ in vitro diagnostic reagent clinical trial
Basic documentation list for medical devices/ in vitro diagnostic reagent clinical trial

The following are the fundamental changes made for the new GCP standard:

1. Re-organization of Overall Structure

This reorganization clarifies the responsibilities of each involved party to ensure the quality of the clinical trials. It will enhance not only the requirement of clinical trial site, but also the responsibility of investigators.

Responsibilities of Applicant

As compared to the previous GCP standard, the new standard escalates the liabilities of the applicant in medical devices clinical trials. The applicant is expected to be truthful and legally compliant when carrying out medical devices’ clinical trials. If it is not a company based in China, there will be a need for a legal Chinese person to act as an agent to take up this responsibility.

A quality management system that covers the entire process of the medical device clinical trial must be instituted to ensure that the relevant laws and regulations are complied, and the interests and safety of the patients are protected. This system should cover:

Selection of the medical device clinical trial institutions and main researcher
Clinical trial plans design
Clinical trial implementations, record, report, and filling.

This promotes the responsibility of the applicants for the legal compliance during the entire process of the clinical trial.

The rights and obligations of each party involved in the medical devices clinical trial must be specified clearly in their contracts with medical devices clinical trials institutions and main researchers.

The applicants also need to be responsible for the organization of trainings related to the medical device clinical trials, inclusive of theory, application scope, performance characteristics, operation method, installation requirements, technical indicators, standard operation procedure, and other relevant documents. This new GCP standard provide more detailed rules and timing for trainings.

Responsibilities of Researchers

The first recorded for the clinical should be the main researcher, who needs to comply with the GCP standard, as well as other law and regulations regarding the implementation of the clinical trials.

The limitation for specified qualification requirements for deputy director, deputy professor, or deputy research, or above, has been removed. Instead, a broader experience requirement for researchers is required.

2. Number of Medical Device Clinical Trial Institutions are Simplified

This new standard overwrites the previous GCP standard with the requirement that clinical trials need to be carried out by at least 2 separate clinical trial institutions and removed the 1 year validity period of product inspection report for clinical trials us, simplifying the cost and time for clinical trials.

3. Procedure for serious adverse event

Researchers’ Reporting Obligation

All researchers must report serious adverse event of the clinical trials to the applicant, drug administrative authorities in charge of clinical trial institutions and the Ethics committee, instead of only reporting to the drug administrative authorities in-charge.

Applicants’ Reporting Obligation

The applicant on the other hand, needs to report serious adverse event of clinical trials to not only the participating clinical trial institution, Ethics Committee, and main researcher, but also the drug administrative authorities at the provincial level, the health authorities and the provincial drug administrative that the applicant registered with.

An adverse event that caused casualties and/or is life threatening must be reported by the applicant within 7 days of knowledge, the clinical trials must also be ceased. Otherwise, the applicant needs to report it within 15 days of knowledge. 4. Scope of application for In Vitro Diagnostic Reagents

The new GCP standard will also be extended to clinical trials in connection with in vitro diagnostic reagents. In Summary,

There was a reorganization of the framework of GCP such that the responsibilities of the involved parties are clarified.
The IVD clinical trial will now be regulated, similar as medical devices, for GCP.
There are some adjustments in the safety information reporting process
Some requirements have been optimized and simplified.
Medical Device clinical trials no longer needs to be conducted in 2 or more clinical trial institutions
1-year validity requirement on test report is removed.