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General |
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Classification of medical devices |
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Control on use of selected medical devices |
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General |
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What is a medical device? |
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Medical devices range from sophisticated equipment such as cardiac
pacemakers used by health care professionals to simple products
such as bandages and thermometers bought over the counter by the
public.
In essence, a medical device refers to any instrument, apparatus,
appliance, material or other article, excluding drugs, used for
human beings for diagnosis, prevention, treatment, monitoring of
diseases or injuries; or for rehabilitation purposes; or for the
purposes of investigation, replacement or modification of body structure
or function. In addition, it includes devices used for examination
of human specimens.
An accessory to a medical device is subject to the same regulations
that apply to the medical device itself. However, devices designed
for the treatment or diagnosis of diseases and injuries in animals
are outside the scope of the proposed regulatory framework.
Please refer here
for a full definition of medical device as adopted from the Global
Harmonization Task Force (GHTF).
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What is the existing legislative
control of medical devices? |
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Currently, there is no specific legislation to regulate the importation
or sale of medical devices in Hong Kong except those containing
pharmaceutical products or emitting ionizing radiation.
The Consumer Goods Safety Ordinance (Cap.456) provides protection
against the supply, manufacture or import of unsafe products, including
some medical devices that can be regarded as consumer goods, unless
otherwise specified in the Schedule. The Electrical Products (Safety)
Regulation (Cap.406G) provides protection against the supply of
unsafe electrical products including medical devices designed for
household use except those products specified otherwise.
The statutory regulation of certain health care professionals,
whereby the practitioners are required to ensure the safe and appropriate
treatment for patients, also provides incidental control on the
use of medical devices.
The Undesirable Medical Advertisements Ordinance (Cap.231) prohibits
advertisements related to the curative or preventive effects of
products on diseases listed in the Ordinance.
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Why do we need to regulate medical
devices? |
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Following are the major problems identified at present -
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No pre-market control to assess the safety, efficacy and quality
of medical devices to safeguard public health;
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No specific control on the use of selected medical devices
by non-medical professionals to ensure the safety of consumers;
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No formal adverse incident reporting and proactive surveillance
systems;
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Inadequate product information for the public and operators
to make informed choices on the safe use of medical devices.
In view of the above, there is a need to develop an appropriate
regulatory system to control the supply and use of medical devices
in Hong Kong.
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Does regulation limit the choice of medical
devices available in the market?
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We should strike a balance between providing consumers with sufficient
choice and offering the community medical devices that perform safely,
efficaciously and as intended. The Government is aware of the potential
cost implication to the trade and users of medical devices. Therefore,
we propose a cost-effective, risk-based regulatory approach with
reference to harmonized international standards recommended by the
relevant international authority - Global Harmonization Task Force
(GHTF) on medical devices. The degree of control will be relative
to the level of risk associated with a device.
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What is the progress so far?
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To raise public awareness on the safe use of medical devices and
enable traders to familiarize themselves with the future mandatory
requirements, the Government has launched a Medical Device Administrative
Control System (MDACS) on 26 November 2004. The first phase of MDACS
starts with voluntary listing of Class IV (High Risk) Medical Devices.The
second phase of MDACS, which includes voluntary listing of Class
II & Class III (Medium Risk) Medical Devices,
has been launched on 14 November 2005. The list of medical devices will be posted on our website as reference for the public in due course.
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Do overseas countries have regulation on medical
devices?
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Many regions and countries like the European Union, USA, Australia,
Canada, and Japan already have their own systems for the control
of medical devices. Asia-Pacific countries such as the Mainland
China, Philippines, Indonesia, South Korea and Thailand also operate
their own systems to regulate medical devices. Singapore will soon
implement her own mandatory control on medical devices.
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What is the Global Harmonization
Task Force (GHTF)? |
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GHTF is a voluntary
consortium with representatives from the trade and regulatory authorities
from USA, Canada, Australia, Japan and the European Union formed
in 1992 to harmonize the standards and principles of regulating
medical devices.
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Classification of medical devices |
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How many classes of medical
devices are there? |
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Adopting from the Principles of Medical Devices Classification
proposed by the GHTF, medical devices are grouped into four (4)
classes according to the risk level associated with their intended
use. Class IV Medical Devices bear the highest risk whereas Class
I Devices bear the lowest risk. Please refer to the principles
and rules
of classification for details. Some general examples
of classified devices can also be found in our website (please
note that the listed examples are for the purpose of illustration
only. The classification of a particular medical device depends
on its actual design, intended use, and other factors described
in the following question).
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What are the principles in classifying medical
devices?
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Medical devices are classified according to the risk level associated
with their intended use. In general, the risk level depends on the
design of a medical device as well as its intended use. The actual
classification of each device also depends on one or several of
the following factors, such as the duration of device in contact
with the body, the degree of invasiveness, whether the device delivers
medicines or energy to the patient, whether they are intended to
have a biological effect on the patient and local versus systematic
effects (e.g. conventional versus absorbable sutures). These factors
may, alone or in combination, affect device classification. For
details, please refer to rules
of classification.
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What is the purpose of separating medical
devices into different classes?
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Safety can only be considered in relative terms. All medical devices
carry a certain degree of risk that could cause problems in specific
circumstances. The level of regulatory control should take into
account the risks and benefits associated with use of the medical
device. To avoid unnecessary burden on trade and provide local consumers
with access to medical devices of latest technology, the rules of
classification separate medical devices into different classes and
subject them to different level of regulatory control.
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How can I know the class of
a particular medical device? |
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The class of a particular medical device is important only for
the purpose of regulatory control, such as a decision on whether
pre-market approval and/or proactive post-market surveillance are
required. As classification of a particular medical device depends
on the risk associated with its intended purpose, the manufacturer
is in the best position to follow the rules
of classification and provide this information. Some general
examples of
classified devices can also be found in our website.
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Control on use of selected medical devices |
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What is the proposed control on
use of medical devices? |
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The proposed regulation emphasizes that some medical devices should
only be operated by properly trained personnel. It aims at preventing
harms or complications arising from improper use of the selected
medical devices by unqualified personnel. Based on public concern
and risk assessment, only laser and Intense Pulsed Light equipments
are initially selected for regulation on their possession and operation.
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What is the impact of the proposed
regulation on registered health care professionals? |
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Registered healthcare professionals using those selected devices
will continue to be regulated by their own professional bodies.
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