Docs of the Month: How to Do Device Trials in China and Ethiopia

China Spells Out Roles, Adds IVDs

NMPA released its specification document in the context of some overarching reforms to its device regulatory framework that came to the fore last June. Those reforms established new rules for determining when clinical trials are necessary to support device registration, and added flexibilities for the types of data that might be necessary, among other changes. The new specifications will replace 2016 regulations addressing clinical trial standards for devices, incorporating elements from the recent reforms and making updates to clarify roles and responsibilities for conducting clinical trials. 

In particular, the new document tries, according to NMPA, to underscore the importance of a trial sponsor’s quality management system and it makes clear that the quality system must address the entire clinical trial process, incorporating principles of risk management. The specification also includes new details defining the roles of testing institutions and researchers in the process. 

Also noteworthy, the new specification includes IVD clinical trials in its scope, which was not the case for the 2016 regulation. In addition, the document specifies a timeline for adverse event reporting from device trials in China—specifically, setting a seven-day deadline (from when the sponsor is informed) to report deaths or life-threatening risks and a 15-day deadline for non-life-threatening issues. And NMPA says it removed what it deemed were unnecessary requirements related to device trials to streamline the process. For instance, it removed the requirement that trials must be conducted at two or more sites. 

The NMPA document also explicitly draws on the work of the International Medical Device Regulators Forum (IMDRF) to establish globally harmonized expectations for device clinical investigations. It also makes full reference to the ISO 14155 standard for good clinical practice in medical device trials and the ISO 10916 standard for IVD trials.

Ethiopia GCPs

Ethiopia is not as far along in building up and modernizing its device regulatory infrastructure as NMPA is in China. Recently, lawmakers in Ethiopia have taken legal steps to further distinguish oversight of devices from that of drugs. And that may be a key objective of its recently published “Guideline for Medical Devices Good Clinical Practice.” Ethiopia already had a 64-page GCP document published in 2018 addressing drugs, vaccines, and dietary supplements, as well as diagnostics and devices. The new document dedicates 42 pages purely to GCP for devices (not including IVDs). 

The guidance, first of all, is intended to help companies and research institutions decide if a clinical investigation for a device is mandatory. It then sets out regulatory requirements for a trial including ethical considerations; responsibilities of principal investigators, monitors, sponsors, and other stakeholders; clinical investigation plans; and clinical investigation reports.

 

Trials that are conducted leveraging the GCPs should provide “scientific justification on clinical effectiveness and safety of medical devices in support of the marketing authorization,” the Ethiopian FDA states in the document, which references the ISO 14155 standard. It doesn’t explicitly mention recent IMDRF work on device trials, but it does refer to the precursor Global Harmonization Task Force (GHTF) in the context of discussing clinical trial design.  

 

The GCP guidance follows a string of other recent foundational, device-focused guidelines issued by the Ethiopian FDA, including one outlining general guidelines for marketing authorization and another on medical device good manufacturing practices. 

 

The documents from China and Ethiopia are two of 53 that were captured in Document Depot in March. China’s NMPA, not atypically, was the most active last month, with guidelines published for an array of technology areas, including in the digital health, diagnostics, and orthopedic sectors.