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Do you haveTechnical Questions on Medical
Device Product Safety? Click to try our 'Ask the Expert' service. |
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Regulatory Affairs The
technical requirements for medical devices are very similar around the world, being based on the national variants of the IEC 60601 series of standards.The medical
device industry is, however, highly regulated. There are both technical and other requirements that must be fulfilled before a medical device can be put on the market in any
particular country. Although 601help's main purpose is to assist in the understanding of of IEC 60601-1, the product safety standard, we also give a brief outline of the FDA's
regulatory requirements (USA), as well as the requirements for compliance with the Medical Devices Directive (European Union). A useful source of regulatory information in other
countries can be found out at the following site. Medical Device Regulatory Profiles for Select Foreign Markets
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Disclaimer
© Powerful Connections 2001-2009. All rights reserved 601help is a Trade Name of Powerful Connections Ltd. The author thanks the International
Electrotechnical Commission (IEC) for permission to use material from the IEC 60601-1 international standard . All extracts are copyright © IEC, Geneva, Switzerland. All rights reserved. Further
information on the IEC, its publications and its role is available from www.iec.ch
. IEC takes no responsibility for and will not assume liability for damages resulting from the reader's misinterpretation of the referenced
material referenced due to its placement and context in this publication. The material is reproduced or rewritten with their permission. |
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