HSA enhances regulatory legislation to facilitate faster access to medical devices
The Health Sciences Authority (HSA) announced that its regulatory legislation will be enhanced to facilitate faster access for certain lower risk medical devices (MDs) and standalone mobile applications.
Acknowledging that medical devices comprise a very diverse group of products, with varying complexities and risk profiles, HSA regularly reviews its regulatory framework to ensure that it remains relevant and effective.
“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.” said Associate Professor Chan Cheng Leng, Group Director, Health Products Regulation Group, HSA.
According to the announcement, HSA will also provide greater clarity to existing policies and requirements for telehealth devices and high risk devices for the modification of appearance or anatomy. The changes will take effect from 1 June 2018.
The changes seek to cater to different operational and emerging business models in the medical device industry, facilitate faster market access and encourage innovations, while safeguarding consumer health and safety.
The regulatory enhancements are the result of regular and extensive engagement with the medical industry. As the time-to-market for new medical devices is shortened, consumer access to these lower risk products will become faster. HSA will continue to engage its stakeholders to further enhance the medical device regulatory framework, while still ensuring that consumers' safety is safeguarded.
Faster market access
From 1 June 2018, the regulations for the following devices will be enhanced as follows:
Class A sterile medical devices, such as sterile examination gloves and sterile intravenous sets, will not need to be registered with HSA. Previously, these devices were subjected to registration to ensure that they comply with the requisite standards on sterility. To ensure safety and facilitate post-market surveillance and monitoring, importers/manufacturers will be required to list all their Class A medical devices on the public online Class A database with HSA.
The current expedited Class B registration route, which currently takes 60 days for the product registration, will be subsumed under the immediate registration route if they meet the following criteria of: (1) no safety issues associated with the device globally, (2) two independent regulatory agencies’ approval, or (3) one reference agency’s approval plus three years of marketing history. With this, 75% of Class B applications, will be granted immediate market access.
Class B and C standalone mobile medical applications that are approved by at least one reference regulatory agency without safety issues globally will be eligible for immediate market access under the immediate registration route. These applications include standalone application for calculation of insulin dosage, or live monitoring of ECG for cardiac patients.
Clarifying regulatory controls
Through this regulatory enhancement exercise, HSA is also clarifying existing controls by specifying in the legislation that:
(1) Telehealth devices intended by its manufacturer for medical purpose will be regulated as MDs. Those intended by the manufacturer solely for well-being or lifestyle purpose, such as smart watch to track heart rate and heart rate measuring devices in smart phones for fitness purposes, and not intended for medical purpose will not be subjected to regulatory controls. However, a clarification statement has to be included on their labels and advertisements that these products are not meant for medical purpose.
(2) High risk devices used for modification of appearance or the anatomy are subjected to regulatory controls. To provide clearer guidance to industry players, HSA has developed a Positive List to help industry players identify if their products are regulated. These products are implants, injectable dermal or mucous membrane fillers, and invasive devices for fat removal or fat degradation purposes.
(3) For more complex MDs that require users to have the relevant skills and knowledge to use them safely and effectively, HSA will require manufacturers to provide training for the users of these devices. Example of such devices are implantable devices where physicians need to undergo training on implantation technique before using the device on the patients.
Moving forward, HSA will continue to strengthen post-market surveillance, which include checks and monitoring of product compliance in the market, as well as close monitoring of overseas alerts and local safety signals. These activities will enable HSA to detect safety signals from the market early and investigate adverse events promptly, safeguarding public health and safety.
Mr Eugene Yoo, Chairman of the Medical Technology Industry Group of the Singapore Manufacturing Federation shares, “HSA continues to be a leading innovative regulator and advancing with the changing healthcare landscape. By putting patients’ health and safety as its core mission, the amendments to the medical device regulations will provide clarity and simplify the work flow for the industry. This will certainly accelerate patients’ access to innovative therapy and technologies; further enhancing the health and wellness of the Singapore population.”