China Releases First-Ever Draft Guidance on Clinical Trials for Medical Devices

June 3, 2016

After releasing 186 new standards for medical devices last month, China FDA has now released details on how it will regulate clinical trials and on-site inspections for devices.

The agency outlines compliance policies and how it will authenticate clinical trial data, in its first-ever draft guidance on clinical trials for devices. The document also discusses which devices will be exempt from clinical studies.

“Previously, there were no legal documents regulating on-site inspections for medical device clinical trials,” said Katherine Wang, partner at Ropes & Gray LLP. “These new drafts, for the first time, introduce a checklist and process for on-site inspections.”

By increasing the frequency of on-site inspections, CFDA hopes to uncover fraudulent data more quickly and stop such practices by eliminating devicemakers without sound quality systems.

The guidance provides checklists via three annexes that outline specific duties for inspectors. The move adds consistency to the on-site inspection process and means that devicemakers can streamline their operations better.

Annex 1 documents requirements for clinical trials of medical devices and IVDs for the following categories:

  • Clinical trial conditions and compliance;
  • Informed consent;
  • Clinical trial data management;
  • Management of tests; and
  • Reporting and registration of clinical trials.

Annex 2 creates a brief checklist for authenticity of clinical testing and trials.

Annex 3 details a clinical trial site inspection program from preparation for inspection to filing final reports.

In a follow-up document, CFDA proposes Class II and III medical devices that are exempt from clinical trials. The exemption applies only to products that follow established standards. If the product uses new materials, design or products, CFDA requests a clinical trial.

The Class II document lists 250 types of lower-risk devices without noting modifications that would require a clinical trial. The Class III document covers 93 types of devices with defining characteristics of exempt products along with examples of modifications that would require a clinical trial.

“Companies intending to launch new devices in China are advised to review their current practices, upgrade their compliance standards to the extent necessary and strictly comply with the upgraded standards,” Wang advises.

But resource constraints will force the agency to conduct random inspections rather than hit all devicemakers. Wang said CFDA would conduct sample inspections “based on complaints regarding the authenticity, compliance and integrity of clinical trial data.”

In May, CFDA set forth 186 standards devices need to meet, as well as parameters for testing, rules of inspections and other technical requirements (IDDM, May 13). — Joya Patel