Regulatory Affairs Professionals Society 131 Index Major discussions of a topic are indicated by page numbers given in bold typeface. In each chapter, tables and figures are indicated by page number with “t” or “f” and the number of the table or figure following, with the chapter number omitted. In chapter 5, Figure 5-1 on page 54 will appear as 54f1. The index includes only countries where there has been substantive information within the text a listing of country names (e.g., organizational mem- bership) without additional information in the text will not be found in the index. Country names found only in tables or figures are not included in the index, although both tables and figures are indexed. A active implantable medical devices (AIMDs), 57–65 country-specific regulatory requirements Australia, 63 Brazil, 64 Canada, 64 EU, 62–63 US, 63–64 definitions and examples, 58–59 general considerations, 59 Premarket Approval application, 63–64 regulatory approval principles device description, 61 labeling, 61–62 manufacturing process validation, 62 risk analysis/control, 62 verification/validation, 62 special considerations for electrical/electromagnetic safety, 60 heat, 60 imaging and treatments with, 60 markings for, 61 mechanical safety, 60–61 radiofrequency communication, 61 sterilization and packaging, 60 surgical technique, 61 adverse event reporting in conformity assessment, 53t7 reporting criteria, 81 requirements for, 83 software, 74 See also postmarket surveillance specific device classes advertising, 85 American National Standards Institute (ANSI), 16 Australia AIMD conformity assessment, 63 IVD regulation for, 51–52, 51t6 Therapeutic Goods Act, 63 Therapeutic Goods (Medical Device) Regulations, 63 B Brazil AIMD regulations, 64 ISO 13485 in, 31, 64 MDSAP Pilot, 31 Medical Devices Regulations, 64 C Canada AIMD regulations, 64 Food and Drugs Act, 64 ISO 13485 in, 31 IVD regulation for, 52–54 mandatory reporting for devices, 85 MDSAP Pilot, 31
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