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Clinical Evaluation & Post-marketing Surveillance of Medical Devices in Singapore

Dr Balamuralidhara V. et al of the JSS College of Pharmacy present a study which examines the clinical evaluation and post-marketing surveillance requirements of medical devices in Singapore. As an integral part of the healthcare system, medical devices come along with a lot of risks which need to be regulated. The new MDR requirements on clinical evaluation are expected to be the greatest challenge for manufacturers of medical devices, and stronger clinical evidence will be needed to demonstrate the safety and efficacy of these devices.