“medical device” 一词涵盖了用于治疗、缓解、诊断或预防疾病或异常身体状态的多种产品。也指Medical Devices Regulations中所指的器械,但不包括任何拟用于动物的器械。 Device(根据《食品和药品法》第2条的定义)——指为以下目的而制造、销售或代表的任何物品、仪器、设备或配件,包括其任何组件,零件或附件: a)诊断...
加拿大卫生部下属的医疗器械局(Medical Devices Directorate,MDD)是监督和评估加拿大诊断与治疗医疗器械的安全性、有效性和质量的国家重要权威机构。监管框架基于以下两个法案: 1.食品药品法(Food and Drugs Act (R.S.C., 1985, c. F-27)) 2.加拿大医疗器械法规(Canadian Medical Devices Regulations SOR/ 98 28...
evaluationcorrectlyandscientificallyandimprovethe registrationefficiency.Fromthepointofviewofregistrationandevaluation,thispaperanalyzedtherequirementsofclinicalevaluationof theclassmedicaldeviceincombinationwiththecurrentlawsandregulationsandprovidethemethodsandessentialsoftheclinical evaluation. Medicaldevice;Clinicalevaluation ...
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...
A manufacturer who intends to market a device of this generic type should (1) conform to the general controls of the Federal Food, Drug, and Cosmetic Act (the Act), including the premarket notification requirements described in? 21 CFR 807?Subpart E, (2) address the specific risks to ...
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 ...
Base on the《Administrative Measures for Medical Device Registration》, The clinical trials for Class III medical device with higher risk to human body should be approved by CFDA. CFDA has issued the《Catalogue of Medical Devices need to be approved prior to Clinical Trial》,and will ...
NMPA (CFDA) Regulations NMPA (CFDA) Newsletters Recorded Webinars White Papers Brochures Recent Events RAPS Webcast: 2023 NMPA (CFDA) Key Updates and Look Ahead on 2024 Medical Device Made-in-China Policy: A Comprehensive Review and Implementation Related Posts 387 IVD Reagents Propose...
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” ...