edical technology (medtech) is an industry with good potential. An ageing population, a growing middle class, and a rising chronic disease burden are buttressing demand for medical devices. Nowhere is this potential bigger than in Asia, home to nearly half of the world’s population and ageing rapidly. Demand for healthcare has already outstripped supply, and the gap will only grow.
Singapore is host to one of the region’s biggest medtech clusters. Since it began to foster medtech in 2000 as part of its broader Biomedical Sciences (BMS) Initiative, it has attracted over 60 multinational medtech companies, including the industry’s top ten, which are leveraging on its well-honed capabilities to undertake a range of activities, including regional headquarters functions, manufacturing and research and development.
They are joined by an increasing number of home-grown companies developing cutting-edge innovations that continue to push the envelope on patient care. Today, there are over 220 medtech start-ups developing healthcare solutions.
In the medtech industry, quality is a watchword as defects or malfunctions can have severe consequences. To avoid accidents and risks to the patients’ health, there are a number of different standards and regulation systems to follow.
A key standard is the ISO 13485 for medical devices. First published in 1986, it was created to harmonise regulatory requirements for medical device manufacturers on an international scale. To receive certification, a medical device organisation needs to demonstrate its ability 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 certified to ISO 13485 are exempted as they have fulfilled the GDPMDS requirements.
The new standard was implemented by the HSA on 9 November 2017. Companies currently certified to HSA GDPMDS have until 9 November 2020 to transition to the new standard.