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DIRECTORY OF CERTIFIED COMPANIES IN SINGAPORE 2019
to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Since then there were two major revisions in 2003 and 2016 to keep it current and relevant for the marketplace. The 2016 version places greater emphasis on risk management and risk-based decision making, as well as changes related to the increased regulatory requirements for organisations in the supply chain.
In Singapore, all companies involved with importing, wholesale and distribution of medical devices must comply with the Good Distribution Practice for Medical Devices (GDPMDS), which seeks to ensure that companies dealing with medical devices have a quality distribution system in place.
Also known as the HSA GDPMDS, it was updated by SPRING Singapore (now known as Enterprise Singapore) in collaboration with the Singapore Manufacturing Federation – Standards Development Organisation and Health Sciences Authority (HSA). Now known as the SS 620:2016 – Good Distribution Practice for Medical Devices, it is mandatory for any organisation involved with the importing, wholesale and distribution of medical devices. Only organisations certi ed to ISO 13485 are exempted as they have ful lled the GDPMDS requirements.
The new standard was implemented by the HSA on 9 November 2017. Companies currently certi ed to HSA GDPMDS have until 9 November 2020 to transition to the new standard.
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