The Health Sciences Authority (HSA) of Singapore has revealed plans to upgrade its regulatory legislation in order to ensure improved access to select low-risk medical devices (MDs) and standalone mobile applications.
The authority also intends to offer more clarity on current policies and requirements for telehealth and high-risk devices involving changes to appearance or anatomy.
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To be effective from 1 June 2018, the enhancements target various operational and emerging business models in the industry. They are intended to enable access and innovations as well as protect the health and safety of patients.
HSA Health Products Regulation Group director Chan Cheng Leng said: “HSA constantly reviews our regulatory framework to ensure that it stays relevant and forward-looking.
“Having obtained a better assessment of the safety profile of MDs in the Singapore market, our moves to allow immediate entry of these lower risk devices would enable us to focus our attention on newer and higher risk devices.”
The changes being made by the HSA include the elimination of registration for Class A sterile medical devices, which must instead be listed with HSA on the public online Class A database.
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By GlobalDataHSA plans to grant immediate market access to Class B medical devices that have no safety issues globally and are approved by two independent regulatory agencies.
Similar market access will be provided to Class B and C standalone mobile medical applications authorised by at least one reference regulatory agency and are fully safe.
HSA expects that by reducing the time-to-market, consumer access to lower risk medical devices will be faster.
In addition, the authority said that telehealth devices designed for medical purposes will be regulated as MDs, while those meant for well-being or lifestyle will not be subjected to regulation.
Regulatory controls are also applicable for high-risk devices indicated for modification of appearance or the anatomy such as implants, injectable dermal fillers and invasive devices for fat removal.
