Since June 1st, 2014, the newly revised Regulations for the Supervision and Administration of Medical Devices (State Council Decree No. 650, named Regulation as follow) substitutes the former implemented ordinance. The revised regulation cancel registration process for Class I medical device, which mea...
The foreign enterprise engaged in Class Ⅰ medical device, including Class Ⅰ in vitro diagnostic (IVD) reagents shall apply for the record keeping to CFDA. The application materials shall contain following dossiers:1. <Imported Class Ⅰ Medical Device R
In order to do a good job in the filing of Class I medical devices, according to the "Regulations on the Supervision and Administration of Medical Devices" (Order No. 739 of the State Council), "Administrative Measures for Registration and Filing of Medical Devices" (Order No. 47 of the ...
In accordance with the Regulations on the Supervision and Administration of Medical Devices (State Council Decree No. 680 in 2017): the State classifies and regulates medical devices on the basis of level of risk. Class I medical devices are those at low level of risk, and their safety and ...
(industry standards)); 3,productsshouldhavesafetyperformancetestreport; 4,theproductshallcomplywiththe"medicalequipmentmanual, labelandpackaginglogomanagementregulations"manual; Five,applicationmaterials (1)registrationofmedicaldeviceproducts; 1.registrationformformedicaldeviceproducts; 2.medicalequipmentmanufacturing...
or national standards, (industry standards)); 3, products should have safety performance test report; 4, the product shall comply with the medical equipment manual, label and packaging logo management regulations manual; Five, application materials (1) registration of medical device products; 1. reg...
Based on the huge market in China, the amount of imported Class I medical device grow steadily. In order to regulate the imported medical devices, CFDA keep updating their regulations. The imported medical device companies might be curious about the medical device recording and regist...
in place the regulations prescribing the class of persons referred to in paragraph (c) of [...] legco.gov.hk (d) 在 研究條例草案第77條擬議新 的第(5)款所 載“ 利害關 係人” 的 定義時,委員請 政府當 局在《 土地業權條例》生 效之前訂立規例, 訂明該定義(c)段中所 述 類別的人...
qualificationofclass IIIsterilemedicalequipments, has established complete production quality management system, passed Shanghai Food and Drug Administration “Medical Equipment Manufacturing Management Standard –Sterile MedicalDeviceImplementing Regulations” ...
2.加拿大医疗器械法规(Canadian Medical Devices Regulations SOR/ 98 282) 三、产品分类 需要先对器械进行分类,才能按照不同类别准备申请资料: 依据器械的使用风险将医疗器械及体外诊断器械分为四类,依次为Class I、 Class II、Class III、Class IV。当中Class I类器械是最低风险,Class IV类器械风险为最高。