Role of PMS for Medical Devices in India
Along with medicines, medical devices are also an important component of the healthcare system. Because of their significance in the healthcare system, it is necessary to check their efficacy and safety. It is not possible to test every single safety concern during the pre-market testing phase. Through post-market surveillance, any potential flaw that requires corrective action can be detected. During this phase, other long-term safety concerns that need to be corrected as per the regulatory policies and guidelines can also be determined. India is also strengthening its post-market surveillance regulatory requirements. Post-market surveillance for medical devices refers to the regular monitoring and evaluation of medical devices once they are launched in the market. PMS studies for medical devices involve the collection, analysis, and interpretation of data related to the safety, performance, and effectiveness of the newly-launched medical device in real-world s...