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At present, post-market surveillance (PMS) is getting more attention and an important requirement for all over the world markets of medical devices after EU MDR regulatory requirement is released in the year of 2017. Global Harmonization Task Force (GHTF), which defines the specific tasks needed for post-market surveillance in the industry harmonized across the world regulatory environments. A systematic procedure to proactively collect and review and implement in case of any CAPA when devices placed on market for consumption. ISO 13485:2016, requires manufacturers to maintain a PMS system mandatory. A compliant PMS plan should consider information concerning serious incidents, records of non-serious incidents, available data on side-effects, information from trend reports, any feedback or complaints provided by users, distributors, or importers of the medical device, and publicly available information about similar devices. Regulatory requirement is emphasizing post-market surveillance and risk management for all the products available in the market. Manufacturers needs to comply regulatory requirements of PMS system in order to market their products around the world.


Medical device Post Marketing Surveillance EUMDR QMS safety

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