Research on Marketing Permission of Cross-border Transfer Production of Medical Devices.
10.3969/j.issn.1671-7104.2020.03.013
- Author:
Wenwu ZHU
1
Author Information
1. Zhejiang Center for Medical Device Evaluation, Hangzhou, 311121.
- Publication Type:Journal Article
- Keywords:
marketing permission;
production address change;
quality management system;
risk assessment
- MeSH:
Equipment and Supplies;
Marketing
- From:
Chinese Journal of Medical Instrumentation
2020;44(3):249-252
- CountryChina
- Language:Chinese
-
Abstract:
At present, there is a growing call for overseas registration applicants to transfer the products that have been approved for import registration to China's domestic production. It deserves our regulatory authorities to study how to face and properly deal with this issue. First of all, this paper systematically combs the regulatory requirements of FDA, EU and Japan on the change of manufacturing site address. Secondly, the paper briefly analyzes the current regulatory differences between domestic and imported devices. Finally, according to the experience and practice of foreign countries, combined with the actual situation of our country, this paper puts forward suggestions on how to meet the needs of overseas registrants to transfer products to domestic production.
