Drugdu.com expert's response:

Whether supporting instruments require prior certification when in vitro diagnostic (IVD) reagents undergo clinical trials necessitates a case-by-case analysis, as detailed below:

I. Supporting Instruments Already Marketed and Certified

If the supporting instrument is a product already on the market and has obtained relevant certifications (e.g., medical device registration certificate), it can be directly used in clinical trials. In this case, the following must be ensured:

Complete Instrument Qualifications: Provide the instrument's production license, quality management system certificate, product inspection report, and other documents to demonstrate compliance with regulatory requirements.

Sufficient Performance Verification: Clearly specify the model, specifications, and compatibility with the reagent of the supporting instrument in the clinical trial protocol, and verify its detection performance (e.g., accuracy, precision) through pre-trials.

Comprehensive Usage Records: Document the receipt, storage, distribution, usage, and maintenance of the instrument to ensure traceability throughout the trial process.

II. Supporting Instruments as Unmarketed New Products

If the supporting instrument is a new product not yet certified, a phased approach is required:

Separate Regulatory Frameworks for Reagents and Instruments: IVD reagents and supporting instruments (e.g., medical devices, MD) are subject to separate registration applications, with no mandatory sequencing requirement.

Key Prerequisites:

Instrument Finalization: Ensure the instrument's design, manufacturing process, and performance are stable to prevent data reliability issues due to changes during the clinical trial.

Performance Verification and Confirmation: If using instruments manufactured by another company, select those already approved for marketing in China and complete comprehensive performance verification of the reagent on the supporting instrument (e.g., analytical sensitivity, specificity).

Ethical and Regulatory Compliance: The clinical trial protocol must undergo ethical review to ensure instrument usage meets requirements for subject protection (e.g., safety, privacy).

III. Special Scenarios and Considerations

Instruments Manufactured by Other Companies: If using instruments from another manufacturer, the following must be met:

The instrument must be approved for marketing in China.

Performance verification data for the reagent on the supporting instrument must be complete and comply with registration technical requirements.

International Regulatory References: The EU IVDR mandates the use of high-quality, standardized instruments in clinical trials and the establishment of quality control systems. While not directly applicable in China, its rigorous approach to instrument performance verification can be referenced.

Dynamic Regulatory Requirements: During clinical trials, stay updated on regulatory changes (e.g., revisions to the Good Clinical Practice for Medical Devices) to ensure ongoing compliance with the latest standards for instrument usage.