Workshop with the Centre for Medical Device Evaluation on Guideline for Clinical Data Submission

2021-10-14 | Beijing

The Healthcare Equipment (HCE) Working Group and COCIR participated in a workshop organised by the Centre of Medical Device Evaluation (CMDE) on the draft Guideline for Clinical Data Submission.

Clinical evaluation is recognized as the most important change of the revision of medical device regulations this year. With this Guideline, companies have more clear understanding on how to submit data of clinical investigations.

COCIR 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 investigations 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.