2007 to 2008 to examine the implications of the possible options for the proposed statutoryregulation of medical devices. legco.gov.hk legco.gov.hk 為配合設立法定規管架構的 工作,當局於2007至 2008年期間進行規管影響評估, 研究建議立法規管醫療儀器的各個可行方案的影 響。
The regulation of medical devices requires a unique blend of science, law, public health policy, and common sense. This has posed an enormous challenge to both the Food and Drug Administration (FDA) and the industry since the passage of the Medical Device Amendments in 1976, and it has led...
The regulation of medical devices presents unique difficulties because of the breadth and complexity of the industry. Experts agree that increased federal control is essential to adequately protect the public, because of the serious loopholes in the Food and Drug Administration's current premarketing con...
FDA Medical Device Regulation Current FDA regulation of medical devices is based on the Food, Drug, and Cosmetic Act (FDCA) as modified by the Medical Device Amendments of 1976 (MDA). The MDA substantially changed U.S. device regulation, integrating many features that had ...
US regulation of medical devices "flawed," report says Canadian Medical Association Journal (CMAJ)Vogel, Lauren
Interventional radiologists use medical devices on a daily basis and so must be aware of the impact that this new regulation will have on their daily practice.Materials and MethodsIn this paper, we describe the major transformation that the MDR brings to the medical devices sector, with a focus...
Regulation of medical devices.Regulation of medical devices.Comments on the lack of regulation of medical devices in Canada. Reports that the Consumer's Association of Canada (CAC) is represented on the committee charged with reviewing regulation and formulating recommendations.EBSCO...
UDI (Increased traceability of devices) 作为医疗器械制造商,在产品投放市场之前,您必须确保产品满足相关监管要求。 欧盟European Union 欧盟医疗器械法规Medical Device Regulation (MDR) 2017/745 查看行业和法规指南了解更多信息。 BSI荷兰 (2797) 是全球领先的欧盟公告机构,具备MDR和IVDR全范围认证资质授权。BSI英国...
The IVDR transition will bring positive changes to EU regulation of medical devices and lab-developed tests. It also presents potential obstacles – which we can help you conquer quickly. With our ability to help ensure your compliance, supply consistency, validation, and scalability, we offer clar...
On March18th, 2021, the newly revisedRegulations on Supervision and Administration of Medical Devices (《医疗器械监督管理条例》, “New Regulation”)has been officially publicized. The New regulation will take effect from June 1 and rep...