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Pharmaceutical Manufacturing and Packing Sourcer
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Unique device identification (UDI) is a system used to identify medical devices entering the healthcare supply chain. Each device (and version or model thereof) will have a designated number assigned by the manufacturer or labeller which must be added in both machine- (Auto ID) and human-readable form to both the packaging and, in some cases, the device itself, provided doing so is required under the regulation. The rule also necessitates dates on medical device labels to conform to a standard format: day-month-year (eg, 30-09-2013) to ensure dates are unambiguous and clearly understood by device users. Standards have been developed by regulators, such as the FDA, to increase patient safety via the ability to effectively track devices through their distribution and use. In Europe, the European Commission has introduced the European Medical Devices Directive to ensure the health and safety of EU citizens is protected in this area (1).
As a globally recognised standard, every medical device manufacturer will be required to comply with the regulations, which state that a UDI must be included on device labels and packages, unless an exception or alternative is stated within the rules.
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News and Press Releases |
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Huge CPhI & P-MEC China a direct result of surging manufacturing
Shanghai, 22 July, 2019:CPhI and P-MEC China – organized by China Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE), Informa Markets, and Shanghai Sinoexpo Informa Markets – saw record numbers of attendees as the pharma market in China continues to grow. The three-day Shanghai event featured 3,200+ exhibiting companies, spanning the entire pharma supply chain, and provides a strong indication of the market’s overall growth patterns and future development.
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White Papers |
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Clinical Trials in Ukraine: Orange Paper Overview and 1st Half Year 2014
Synergy Research Group
The Orange Paper is an analytical report about the clinical trials
market in Russia, published quarterly by the contract research
organization Synergy Research Group. The first edition of Orange Paper
was released in 2006, and at the moment 31 issues have already
published. Now, thanks to Synergy Group Ukraine, obtaining information
about the market of clinical trials in Ukraine has become possible.
In
Ukraine, during the period from 1996 to 2013, applicants had obtained
3,864 positive conclusions about the possibility of conducting clinical
trials of drugs, both for domestic and foreign manufacturers, including
conduct of multinational multi-center clinical trials (hereinafter –
MMCTs)
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Industry Events |
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2020 Avoca Quality and Innovation Summit
3-4 June 2020, Amsterdam, The Netherlands
The 2020 Avoca Quality and Innovation Summit will take place 3-4 June
2020, in Amsterdam, The Netherlands.
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