The literature search and screening report for clinical evaluation of medical devices must be compiled covering following parameters. The accuracy and comprehensiveness of the literature should be guaranteed.
Literature Search and Screening for Clinical Evaluation of Medical Devices
- Device name:
- Model and specification:
- Time range of search:
- Search database:
- Search methods:
- Search terms:
- Logical matching of the search terms:
- Output of search results:
- Description, causes of search deviation and impact on the results:
- Literature screening procedure:
- Literature screening criteria:
- Excluded literature:
- Reasons of exclusion:
- Output of literature screening results:
- Description, causes of screening deviation and impact on the results:
Note: All searched and screened literature needs to be listed in a consistent format. It is suggested to include such information as “author, title, journal name, year of publication, number of volumes (issues), and page number”
- Personnel signature for literature search and screening:
- Date:
Download the template here:
Template for Literature Search for Clinical Evaluation of Medical Devices
Source: National Medicinal Products Administration
Pathway for Clinical Evaluation Medical Devices
