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HSA enhances regulatory legislation to facilitate faster access to medical devices

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:

Credit: Health Sciences Authority

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.

Credit: Health Sciences Authority

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:

Credit: Health Sciences Authority

(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.”

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