中国医疗器械信息
中國醫療器械信息
중국의료기계신식
CHINA MEDICAL DEVICES INFORMATION
2014年
12期
49-52
,共4页
医疗器械%产品质量%监督抽验%影响因素%调查探讨
醫療器械%產品質量%鑑督抽驗%影響因素%調查探討
의료기계%산품질량%감독추험%영향인소%조사탐토
medical devices%the product quality%supervision%inlfuencing factors%investigate and discuss
目的：探索四川医疗器械产品质量监督抽验优势与不足，促进产品质量监管的规范化、制度化。方法：通过文献查阅，到质量监管部门调研与访谈，分析影响因素，提出思考与对策。结果：四川产品质量监督取得显著成绩的同时，在抽验品种数、范围和抽样任务等方面不适应产品发展需要。结论：要保证产品质量，必须扩大抽验范围、增加样品来源、提高抽验人员素质、强化政府监管职能，才能促进四川医疗器械健康发展。
目的：探索四川醫療器械產品質量鑑督抽驗優勢與不足，促進產品質量鑑管的規範化、製度化。方法：通過文獻查閱，到質量鑑管部門調研與訪談，分析影響因素，提齣思攷與對策。結果：四川產品質量鑑督取得顯著成績的同時，在抽驗品種數、範圍和抽樣任務等方麵不適應產品髮展需要。結論：要保證產品質量，必鬚擴大抽驗範圍、增加樣品來源、提高抽驗人員素質、彊化政府鑑管職能，纔能促進四川醫療器械健康髮展。
목적：탐색사천의료기계산품질량감독추험우세여불족，촉진산품질량감관적규범화、제도화。방법：통과문헌사열，도질량감관부문조연여방담，분석영향인소，제출사고여대책。결과：사천산품질량감독취득현저성적적동시，재추험품충수、범위화추양임무등방면불괄응산품발전수요。결론：요보증산품질량，필수확대추험범위、증가양품래원、제고추험인원소질、강화정부감관직능，재능촉진사천의료기계건강발전。
Objective:To explore the strengths and weaknesses of Sichuan Medical Devices Product Quality Supervision and sample testing, and promote the standardization and institutionalization of product quality supervision. Methods:To consult references, research and cover the quality supervision department, analyze the inlfuencing factors, and put forward thinking and countermeasures. Results: Remarkable achievements have found their way in Sichuan Product Quality Supervision, while the varieties, the range and tasks of product samples are not suited to the development of products.Conclusion:In order to ensure the quality of products, we must expand the scope of random testing, increase the source of samples, improve the quality of personnel, and strengthen the government’s regulatory functions. Only in this way can we promote the healthy development of medical devices in Sichuan.
