Medical Devices Regulatory Agency

Medical Devices Regulatory Agency

When the U.S. Food and Drug Administration approved implanting microchips in humans, the manufacturer said it would save lives, letting doctors scan the tiny transponders to access patients medical records almost instantly. The FDA found reasonable assurance the device was safe, and a sub-agency even called it one of 2005 s top innovative technologies. But neither the company nor the regulators publicly mentioned this: A series of veterinary [...]

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CE Marking Medical Devices Regulations

CE Marking Medical Devices Regulations

Manufacturers of Class I (sterile / measuring) devices IIa, IIb and devices shall be certified with respect to the CE marking Directive 93/42/EEC by a notified body before using the CE mark and place products on the market. To allow your organization to achieve certification on the CE, SGS is Notified Body 0120 in accordance with Directive 93/42/EEC for all devices including combination drug / medical device and associated directives 2003/32/EC (animal [...]

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Medical Device Regulations Canada

Medical Device Regulations Canada

See also our entire regulatory consulting services and medical device registration services . If you sell medical devices in Canada, you ll probably need a license to do so. Health Canada (the Food and Drug Administration in Canada) are two types of licenses. Health Canada Medical Device Establishment License (MDEL, operating license for medical devices) Manufacturers of medical devices in Class I and in-vitro diagnostics have a Medical Device Establishment [...]

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Regulations for Medical Devices

Regulations for Medical Devices

European regulations In 1985, Europe has adopted a policy of the New Approach to technical harmonization and standardization to promote the free movement of medical devices. These medical devices are covered by the Guidelines: Directive 93/42/EC (consolidated with amendment 2007/47) concerning medical devices (MD). This directive contains the essential requirements for safety, health, environment and consumer protection. The Directive 90/385/EEC (consolidated [...]

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Norway Medical Devices Regulation

Norway Medical Devices Regulation

Thursday July 28,2011 00:06 Written by Joana2015 The European Commission has presented a new directive,the 2011/65/EU,which prohibits heavy metals and other dangerous chemicals in electrical and electronic equipment on a much wider range of products,with their associated rules. The new legislation will improve the safety of electronic products such as thermostats,medical devices and control panels and prevent the release of hazardous substances into [...]

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US FDA Medical Device Regulations

US FDA Medical Device Regulations

Portugus | English DECLARATION OF COOPERATION BETWEEN THE FOOD AND DRUG ADMINISTRATION OF THE UNITED STATES THE THERAPEUTIC GOODS ADMINISTRATION OF AUSTRALIA The AGNCIA NACIONAL DE VIGILANCIA Sanitaria OF BRAZIL AND GENERAL HEALTH PRODUCTS AND FOOD BRANCH OF CANADA ABOUT THE PROGRAM SINGLE MEDICAL AUDIT The Food and Drug Administration (FDA) of the United States. the Therapeutic Goods Administration (TGA) of Australia, the Agncia Nacional de Vigilncia [...]

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Medical Devices Regulatory Europe

Medical Devices Regulatory Europe

2013-07-23 08:36 PR Newswire [PRNewswire / Shanghai] Shanghai July 23, 2013 / PRNewswire PRNewswire / - CPhI Conferences organized by the Innovation Technology Forum and Regulatory Summit 2013 ) will be held September 24 to 26 at the Shanghai World Expo Exhibition and ninth MEDTEC China exhibition held concurrently. The summit will be updated as new technologies and regulatory focus, continuity MEDTEC exhibition will be high-quality, multi-dimensional [...]

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Dubai Medical devices Regulations

Dubai Medical devices Regulations

List of consulting services to quality systems. In Canada, the medical device market is regulated by Health Canada. Manufacturers of Class II, and IV must meet the quality system requirements of ISO 13485:2003. Companies that do not by a Health Canada CMDCAS accredited registrar are certified (link in English) ISO 13485:2003, can not sell their products in Canada. Health Canada requires manufacturers of Class II, and IV also that these make an application [...]

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