Workshop with the Centre for Medical Device Evaluation on Guideline for Clinical Data Submission for Invitro-Diagnostic Products

2021-10-20 | Beijing

The Healthcare Equipment (HCE) Working Group and Consumable and Disposable Medical Device Advisory Committee (CDMD AC) participated in a workshop organised by the Centre of Medical Device Evaluation (CMDE) on the draft Guideline for Clinical Data Submission for Invitro-Diagnostic (IVD) Products.

About 90% of IVD product registrations require clinical trials in China. With this Guideline, companies have more clear understanding on how to do clinical trials, get what kind of data, and generate reports for IVD product registration submissions.

CDMD AC and the HCE Working Group had raised comments before the workshop. As a result, the requirements in the version for the workshop, are better harmonized with international requirements. The discussion during the workshop covered questions from hospitals, so as when companies do clinical trials at hospitals, how to generate clinical data is aligned.

The guideline will come into effect as soon as it will be published, likely in January 2022.