CE marking on medical devices indicates that they comply with the applicable European legislation with regard to product safety. Part of the CE marking process is drafting the Instruction For Use (Hereafter: IFU). The IFU provides general information on the use of the medical device as well as safety information including warnings. The Medical Devices
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Does Private Labelling still exist? In the medical device world often already certified products are being bought by companies with the intention to bring them onto the European market under their own trade name. This is commonly known as bringing a product onto the market under private label or plainly private labeling. Whereby the Original
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For the CFDA Medical Device Certification the China Food and Drug Administration (CFDA) recently released the 2016 Annual Report for National Medical Device Adverse Event Monitoring, which includes the general situation of medical device adverse event reporting, the statistical analysis of medical device adverse events, the intensive monitoring of medical device adverse event，the quality assessment
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On May 5th 2017 the Official Journal of the European Union published the new Medical Devices Regulation (EU) 2017/45. According to the new Medical Devices Regulation the Regulation enters into force on May 26th 2017. The current legislation on medical devices, i.e. the Medical Devices Directive 93/42/EEC, will be repealed with effect from May 26th 2020. As such there will be a transitional period of three years for all parties concerned with medical devices to adjust their activities in order to comply with the new Medical Devices Regulation.
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In order to determine whether your standalone software is considered to be a medical device it must first be determined what type of operating software is to be used. For example, is your software online software that runs through an internet browser, standalone software that operates without internet connection, or a program running separate from
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Medical device manufacturers who want to bring their devices onto the Union market, must understand three essential elements when complying to the MDD. Device manufacturers that want to enter into the EU Market need to understand three essential ideas: the role of the competent authorities, contract with an EU Authorised Representative, and how to use
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Is my product a medical device (MD)? To know if your medical product falls within the scope of the CE marking legislation you must ensure if the product is classified as a medical device as defined in Directive 93/42/EEC. In the Medical Devices Directive (93/42/EEC) a medical device is defined as:
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The new European Union RoHS Recast Directive that comes into force on July 22 applies to all medical devices. The devices have to comply with some restrictions on certain metals that can become toxic and leach into groundwater, or become hazardous ash when incinerate. The banned materials include lead, cadmium, mercury and polybrominated flame retardants,
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India’s medical device industry has become a booming business. As one of the largest markets in Asia, the government’s health initiatives are increasing and expected to grow in the upcoming years. The country’s Union cabinet agreed to examine the standing committee’s recommendations to modernize medical device regulations.
Read moreE-cigarettes have been a topic of conversation lately since experts aren’t sure whether these electronic cigarettes are a harmful alternative for smoking. The vaporizer cigarettes are metal tubes that are designed to look like real cigarettes and contain a cartridge filled with a liquid that is vaporized by a battery-powered heating element. Manufacturers say
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