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The Medical Device Developer's Guide to IEC 60601-1

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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


 

FDA

Medical Devices Directive

Technical File

Other Countries

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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.