Research on inspiration to medical device market access system from FDA's critical pathplan / 中国医学装备

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.

Quality control research of cold light source of endoscope / 中国医疗器械杂志

This paper introduced the significance parameters of the quality control of cold light source of endoscope, expounded the importance and necessity of quality control of cold light source; it investigated several manufacturers, analyzed and discussed the main causes of the cold light source uneven, in order to realized the standard management and effective supervision on the cold light source, at the end, the next step quality control work was brought out, which provide technical support for quality supervision of cold light source.