Medical Device Regulatory Practices: An International by Val Theisz

By Val Theisz

This publication is meant to function a reference for pros within the clinical equipment undefined, fairly these looking to research from sensible examples and case reviews. scientific units, like prescription drugs, are hugely regulated, and the bar is raised always as sufferers and shoppers count on the best-quality healthcare and secure and potent clinical applied sciences. acquiring advertising authorization is the 1st significant hurdle that med techs have to conquer of their pursuit of business luck. such a lot books on regulatory affairs current laws in every one jurisdiction individually: eu Union, united states, Australia, Canada, and Japan. This ebook proposes functional strategies for a coherent, one-size-fits-all (or so much) set of structures and techniques in compliance with laws in all key markets, through the existence cycle of a scientific equipment. It additionally comprises key information regarding overseas harmonization efforts and up to date regulatory traits in rising markets; vital terminology had to comprehend the regulators' language; and examples, case reviews, and functional options that bridge the space among regulatory thought and practice.

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Additional resources for Medical Device Regulatory Practices: An International Perspective

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The product code assigned to a device is based upon the medical device product classification designated under 21 CFR Parts 862–892 [43]. 3610 of Subpart D defines an implantable pacemaker pulse generator as “a device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart”. 3610, both classified as Class III: • Product Code DXY – Implantable Pacemaker Pulse Generator • Product Code DSZ – Pacemaker Battery Any changes in classification (proposed, implemented or withdrawn) are published in Federal Register [44].

EU guidance documents such as Medical Devices (MEDDEV), Notified Bodies Medical Devices (NB-MED), Notified Body Operations Group Best Practice Guides (NBOG BPG) and consensus statements, interpretative documents and Harmonised Standards are not legally binding. They aim to promote a uniform interpretation of relevant regulatory requirements and a common conformity assessment approach throughout the EU [21]. Harmonised Standards are European Norms (EN) developed by European standardization organizations such as the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC), following a standardization request (mandate) from the EC.

Code of Federal July 1, 2015 11:46 PSP Book - 9in x 6in 12 Overview of the International Regulatory Framework for Medical Devices Regulations (CFR), in particular Parts 800 to 1299, covers various aspects of design, clinical evaluation, manufacturing, packaging, labeling and post-market surveillance of medical devices, as well as standards and product reports that apply to radiation-emitting products [3]. Food and Drug Administration (FDA) Good Guidance Practice (GGP) documents and Blue Book Memos, as well as Recognized Consensus Standards issued by various standard organizations such as the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) are non-binding technical specifications intended to help the industry to interpret and apply the regulations applicable to particular regulated products and certain procedures [4, 5].

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