Research on inspiration to medical device market access system from FDA's critical pathplan
10.3969/J.ISSN.1672-8270.2015.11.037
- VernacularTitle:美国食品药品监督管理局关键路径计划及其对我国医疗器械市场准入制度的启示
- Author:
Yubo SHAO
;
Fei LI
- Publication Type:Journal Article
- Keywords:
Food drug fdministration;
Critical path plan;
Medical device;
Market access path
- From:
China Medical Equipment
2015;(11):117-119,120
- CountryChina
- Language:Chinese
-
Abstract:
Objective:Through reading a lot of literature on the critical path planning of FDA, analyzed the contribution and shortage of the critical path plan to China's medical device market access system.Methods: To analyze the critical path planning of FDA by using the method of literature review.Results: China should reference the critical path plan, reform the existing medical instrument market access system, improve the efficiency, simplify the procedure and promote the safety and development of the product.Conclusion: The research on the critical path planning of FDA is very important for the construction of China's modern medical device market access path.
