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Source:
www.hsa.gov.sg |
HSA INTRODUCES REGULATION OF
MEDICAL DEVICES IN PHASES |
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The Health Sciences Authority (HSA) will be
implementing the regulation of medical devices in phases from 1 Nov
2007. |
Medical devices are the first category of
health products to be regulated under the Health Products Act. |
BACKGROUND |
The Health Products Act, which was passed by
Parliament in February 2007 and assented to by the President on 1 March
2007, enables HSA to implement a risk-based regulatory framework, which
allows for varying degrees of controls to be applied to the different
product categories. |
In respect of medical devices, the range of
products available in Singapore has been growing in diversity and
complexity. At the same time, more lay persons are increasingly using
medical devices. |
With these trends, the risks associated with
medical devices are likely to increase over time and it is therefore
timely to formally regulate medical devices under the Health Products
Act to enhance safeguards for patients and consumers. |
In February 2007, HSA launched an 8-week
public consultation on the proposal to regulate medical devices. HSA
also held extensive briefings and dialogue sessions with the device
industry, healthcare professionals, Consumer Association of Singapore
(CASE) and the Advertising Standards Authority to gather their views.
The feedback received was considered in mapping out the regulatory
framework for medical devices. |
PHASED-APPROACH TO REGULATE MEDICAL
DEVICES |
Medical devices cover a wide range of
products, from syringes to artificial hearts with varying risk
profiles. In formulating the medical device regulations, HSA
applied the concept of risk management to keep the level of
regulation proportional to the degree of risk involved in using a
medical device. |
HSA is adopting a phased approach in
implementing the new regulations to minimise the impact to the
supply of medical devices and to provide sufficient time for the
industry to meet the new standards and requirements. The control
measures will be implemented in three phases, starting from 1
November 2007: |
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Upon completion of the licensing and
registration of all dealers, it will be illegal to manufacture, import or
supply unregistered medium and high-risk devices from 1 October 2009 and
low-risk products from 1 October 2010. |
CALL TO MEDICAL DEVICE DEALERS |
HSA will be conducting further trade
briefings to update medical device dealers on the latest
development. The next briefing will be held on 17 October at HSA
Auditorium, Outram Road. Dealers who wish to attend the briefing
can register by contacting HSA’s Centre for Medical Device
Regulation at Tel: 68663560 or email
HSA_CMDR_Info@hsa.gov.sg.
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HSA also encourages medical device
dealers who have not attended any previous trade briefings on the
regulation of medical devices, to come forward and contact HSA for
information on the impending regulations. |
More..... |
HEALTH SCIENCES AUTHORITY
11 OCTOBER 2007 |
Source:
www.hsa.gov.sg Press Release
11 Oct 2007 |
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