Refurbished medical devices fda

AdvaMed Comments on Refurbishing, Reconditioning ...

requirements. For example, used medical devices may be sold on e-Bay without any entity ensuring the safety and effectiveness of the device. The essential issue is that remarketing results in the transfer of a used medical device. If FDA decides to take action in this area, it should

November 6th,2019

devices Fda guidance refurbished medical - WordPress.com

Fda guidance refurbished medical devices Knight Wills Write Content Below is an event of what that suits, butour visit pumpkin forum for more reasons and expert advice. snipNow install and hold untill the installer does your wind. CNet - Cardigan licensing deals price data.

November 6th,2019

Placing on the market of fully refurbished medical devices

3. The Principle of “Placing on the market of fully refurbished medical devices ” It is important to note that the Medical Devices Directives refer to devices which are both “fully refurbished” and “placed on the market”. Clearly this is not the case with a device which is simply repaired or maintained.

November 6th,2019

Regulatory Framework for Control of Refurbished Medical ...

GE Healthcare Regulatory Framework for Control of Refurbished Medical Devices Alfred KWEK Director, Regulatory Affairs, ASEAN GE Healthcare Presentation to APEC Workshop on Remanufactured Goods, Malaysia, 22 Oct 2012

November 6th,2019

Medical Devices Interim Regulation

and/or placing on the market, and/or distribution of medical devices; or acting on behalf of the manufacturer. Fully refurbished medical device: means a used device that has been returned to a state which would allow it to be subject to the same conformity assessment procedures as applied to …

November 6th,2019

GOOD REFURBISHMENT PRACTICE

• Standards for Medical Equipment at time of first placement • Lifetime and serviceability The first key factor for refurbishment qualification is the intended use as determined by the manufacturer including its product specifications. Devices intended for single use or designed as not eligible for refurbishment should not be refurbished.

November 6th,2019

Regulatory Framework for Control of Refurbished Medical ...

Reg lator Frame ork for Control of Ref rbishedRegulatory Framework for Control of Refurbished Medical Devices Alfred KWEK Director, Regulatory Affairs, ASEAN GE Healthcare Presentation to APEC Remanufacturing Event, Singapore, 28 Mar 2012 CURICULUM VITAE ALFRED KWEK Presently, Director, Regulatory Affairs, ASEAN, GE Healthcare

November 6th,2019

AdvaMed Comments on Refurbishing, Reconditioning ...

requirements. For example, used medical devices may be sold on e-Bay without any entity ensuring the safety and effectiveness of the device. The essential issue is that remarketing results in the transfer of a used medical device. If FDA decides to take action in this area, it should

November 6th,2019

Using of Refurbished - Tehran University of Medical Sciences

• The perception that pre-owned medical devices are of lower technology and result in lower quality healthcare; and • The concern that pre-owned equipment may pose safety risks since the U.S. market for preowned devices is largely unregulated and no FDA approval is generally required for pre-owned medical devices exported from the United ...