Research and Thinking of International Coordination Documents for Medical Device Labeling.
10.3969/j.issn.1671-7104.2021.01.017
- Author:
Yuxi YANG
1
;
Jie DENG
1
Author Information
1. Center for Medical Device Evaluation. NMPA, Beijing, 100081.
- Publication Type:Journal Article
- Keywords:
GRRP;
IMDRF;
medical devices Introduction for Use;
quality management of pre-market review
- MeSH:
Product Labeling
- From:Chinese Journal of Medical Instrumentation
2021;45(1):81-84
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To further improve the regulation of medical device Introduction for Use (IFU) and improve the quality of medical device Introduction for Use (IFU).
METHODS:Summarize domestic regulatory experience and deficiencies through literature research, and introduce the international experience gathered from the IMDRF coordination document Principles of Labelling for Medical Devices and IVD Medical Devices.
RESULTS:The IMDRF international coordination document categorizes ten chapters to define and summarize the basic principles that medical device instructions and labels should contain.
CONCLUSIONS:According to the current status of medical device specification supervision and drawing on international supervision experience, improvement suggestions are proposed in terms of refining the IFU requires to improve the quality of the instructions, e.g. dynamic adjustment of IFU management requirements, strengthen the management of IFU for home used medical devices, and improving the standardization and rationality of medical device IFU content. We should continue to maintain effective management of medical device IFU.
