01 Classification of Medical Devices医疗器械分类 通过分类规则将医疗设备分为四个类别,其中Class I 代表最低风险, Class IV 代表最高风险。如果医疗器械可以分类为多个类别,则代表较高风险的类别适用。 ØClassification Rules for Medical Devices described in the Medical Devices Regulations vGuidance Document - ...
Steps for Class I medical devices compliance Classification: ensure the device is a Class I medical device. Choose Conformity Assessment Route: refer theflow chart below. Compile the Technical File. Declaration of Conformity. Appoint an Authorised Representative. (register with the Competent Authority)...
According to the "Regulations on the Supervision and Administration of Medical Devices" (No. 739), medical devices are classified and managed according to the degree of risk. Class I medical device is a medical device with a low degree of risk, and the implementation of routine management can ...
The reason for recall was defined as either a premarket (e.g. device design problems) or a postmarket (e.g. manufacturing problems) issue.75 unique Class I recalls affecting more than 88,000 medical devices were identified from 2002-2016. Recalls included diagnostic assays for ...
For the filing ofimportedClass I medical devices, the filing entity shall submit the filing documentation to the NMPA. When determining the product management category, the product description, expected use and product name examples shall be determined according to the product description, expected use...
devices in Hong Kong and local representatives of overseas manufacturersofmedical devicesbelongingtoClassIIand above. legco.gov.hk legco.gov.hk 我們建議,所有在 香港銷售醫療儀器的本㆞醫療儀器製造商,以及 第 II 級 或以㆖醫療儀器的海 外製造商的本㆞代 表,均須註冊。
International Medical Lasers (IML) sources the highest quality medical devices from around the world, helping manufacturing partners bring them to the US.
Over one year has passed since the implementation of new CFDA regulations on medical device, more and more class I medical devices successfully had been approved and sold in Chinese market. The submission and approval procedure is simplified under new regulations. This webinar will focus on how to...
Domestic and Oversea Class I medical device manufactures CFDA recording challenges forimported class I medical device manufactures Legal representatives The determination of class I medical devices Dossiers preparation that conformed to the CFDA requirements. ...
《医疗器械指令》(MedicalDevice Devices 92/42/EEC),1995年1月1日生效,1998年6月13日强制实施。所有医疗器械制造商或其授权的代表应确保将要进入欧洲经济区(EEA)的医疗器械必须满足该指令要求。 2. 医疗器械CE认证(MDD认证)适用范围: 包括了医疗设备以及它的配件,任何仪器、器具、设备、材料及其它物品,无论是单...