Three‐dimensional printing in surgery: negotiating the regulatory landscape.

Autor: Murray, Becca, Desselle, Mathilde, Forrestal, David, Sparks, Lisa, Drummond, Shaun, Wagels, Michael
Předmět:
Zdroj: ANZ Journal of Surgery; Mar2022, Vol. 92 Issue 3, p325-327, 3p
Abstrakt: Instead, they should audit the devices manufactured, consider whether each is a medical device and then work out on class and type.4 These should be collated under the Global Medical Device Nomenclature codes5 in preparation for ARTG listing. Recent changes to medical device regulation This system has now been updated (25 February 2021).3 The definition of a medical device has not changed. The system for medical device regulation in Australia was recently updated. [Extracted from the article]
Databáze: Complementary Index