%0 Electronic Chapter %T Regulations for other markets %K TGA %K regulatory environment %K therapeutic goods administration %K Australia %K Therapeutic Goods Regulations %K European CE Marking %K medical devices %B Engineering High Quality Medical Software: Regulations, standards, methodologies and tools for certification %D 2018 %I Institution of Engineering and Technology %P 43-50 %R doi:10.1049/PBHE012E_ch4 %S Healthcare Technologies %U https://digital-library.theiet.org/;jsessionid=d48kds57rtt4h.x-iet-live-01content/books/10.1049/pbhe012e_ch4