News

CHINA: Medical Device Clinical Trial Data Submission Requirements for Registration Review Guidelines-No. 91 in 2021 – January, 2022

CHINA: Medical Device Clinical Trial Data Submission Requirements for Registration Review Guidelines-No. 91 in 2021 – January, 2022

  • 2022-01-26 08:31:11

Clinical trial data is one of the important supporting documents for evaluating the safety and effectiveness of medical devices. Standardizing the collection, sorting, analysis, and submission of medical device clinical trial data will not only improve the quality of clinical trial implementation and management but also assist the regulatory agency to understand and review the development of clinical trials quickly and efficiently.

More
CHINA: CNDA has Released a New Catalogue of Medical Devices to Be Exempted from Clinical Trials (Draft) – July 2018

CHINA: CNDA has Released a New Catalogue of Medical Devices to Be Exempted from Clinical Trials (Draft) – July 2018

  • 2020-02-14 03:59:43

In early June, CNDA had issued a draft consisting of the fourth batch of medical device catalogues to be exempted from clinical trials along with the revisions of the first three batches of catalogues, in able to catch up with the upcoming classification to be implemented in July. In this regard, CNDA is currently accepting comments from the public until the end of June 2018.

More