Introduction and Discussion of IMDRF Personalized Medical Device Regulatory Pathways.
10.3969/j.issn.1671-7104.2023.06.015
- Author:
Yue MIN
1
Author Information
1. Center for Medical Device Evaluation, NMPA, Beijing, 100081.
- Publication Type:Journal Article
- Keywords:
medical device regulatory pathway;
personalized medical device;
point-of-care manufacture of medical device
- MeSH:
Commerce;
Medical Device Legislation;
China
- From:
Chinese Journal of Medical Instrumentation
2023;47(6):669-673
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To interpret the key contents of the guidance of Personalized Medical Device Regulatory Pathways issued by the IMDRF, and provide reference for the improvement of China's medical device regulatory system.
METHODS:The regulatory requirements of personalized medical devices and point-of-care manufacture of medical device were described respectively, and the feasibility of implementing the regulation of point-of-care manufacture of medical device in China was analyzed.
RESULTS:The different regulatory pathways of medical devices produced at point-of-care are feasible and have different regulatory risks.
CONCLUSIONS:In combination with the recommendations provided by the IMDRF guidance and the clinical and regulatory realities in China, we should accelerate the improvement of the regulations and supporting documents for point-of-care manufacture of medical device in China.
