1. Medical device regulations: global overview and guiding principles;Cheng,2003
2. Current status of the regulation for medical devices;Shah;Indian J Pharm Sci,2008
3. Food and Drug Administration (FDA). Medical device recalls. [website]. Retrieved October 13, 2023, from https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls.
4. Harmonized medical device regulation: need, challenges, and risks of not harmonizing the regulation in Asia;Saini;J Young Pharm,2010
5. Harmonized technical guidance to industry and regulatory authorities for premarket and post market phase of medical devices main focus towards in vitro diagnostic medical devices IVD [doctoral thesis];Senthil,2022