Clinical evaluation research of medical device registration / 中国医学装备

ABSTRACT

Objective: To help medical device registration applicant understand the content of clinical evaluation, guided on the clinical evaluation method, and also putted forward several suggestions of the improvement scheme for our country registered clinical assessment and review of the work. Methods:Described the Global Harmonization Task Force (GHTF) medical device registration guidance for clinical evaluation, combined with the status quo of supervision in China, and made some specific scheme on China's medical device of clinical evaluation work. Results: Introduced the contents of the clinical evaluation and the relationships between the factors, in order to help the medical device registration applicant and Chinese regulators to do clinical evaluation work of scientific and reasonable. Conclusion:The definition of medical device registration clinical evaluation should clear the clinical evaluation, and to develop guidance for clinical evaluation of the corresponding.