Medical devices, including drug-device combination products and in vitro diagnostics, sustain, and improve the lives of millions of people every day. To ensure these products have the positive effect intended and protect the public from potentially harmful products, government agencies around the world...
For dozens of years, many regulations for medical devices have been established around the world with the USA and European Union playing major roles. Introducing new legislation and simply to its huge market size, China will get more important as well. The aim of this chapter is to introduce ...
Medical Devices: Regulations, Codes, and Standardsgovernment regulationmarketingdistributionmanufacturingmedical device evaluationThe approach that various countries have taken to regulate the marketing of medical devices differs, greatly as does their use of standards for medical devices. The United States ...
The requirements for the medical device manufacturers: 1. Professional and technical personnel required for the development and production of customized medical devices; 2. Have customized medical device development capabilities and research foundation; 3. Have the same type of medical device registration ...
New Regulations for Medical Devices in Russia and Their ImplicationsNew Regulations for Medical Devices in Russia and Their ImplicationsIntroductionGlobalData's report, "New Regulations for Medical Devices in Russia and Their Implications" provides information and analysis on the up-coming medical devi...
Registration procedures for Class I Medical Devices replaced by filing procedures, with greater responsibility placed on applicants Prior to the promulgation of the New Regulation, all medical devices were required to be registered, with Class I, II and III devices being approved by and register...
中文版Medical Devices Regulations SOR98-282601应提交初步报告部长一有关的事件发生在加拿大10天后的医疗设备制造商或进口商变得知悉事件如果事件导致死亡或严重恶化的病人使用者或其他人的健康状态或ii于30天后的医疗设备制造商或进口商变得知悉的事件如果事件并没有导致死亡或严重恶化的患者使用者或其他人的健康状态但...
i.e. either having obtained a manufacturing license for Class II or Class III medical devices or having registered to manufacture Class I medical devices. 6This requirement can, to some extent, impede the work of small and medium-sized enterprises or scientific research institutions. Under the fo...
Regulations for the Supervision and Administration of Medical Devices (No. 650 Decree of the State Council) Issued on March 07, 2014 Decree of the State Council of the People's Republic of China No.650 Regulations for the Supervision and Administration of Medical Devices was revised and passed ...
CHINA will allow use of some drugs and medical devices based on approval by foreign regulators, the government said yesterday. The step was one of a series announced by Chinese drug regulators to improve