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Medical Device
Manufacturing : Definition of Medical Device
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Dr G L Jain |
The purpose of this article is to make a health care
manufacturer familiar with the definition of Medical
Devices so as to identify which of his products fall
within the scope of a harmonized definition of the
term medical device. Although in the present
regulatory scenario in India wherein only few devices
have been modified, this definition may not be
applicable to many products especially to those which
are being manufactured for supply within the country.
However, for those who are offering their products
outside the country and those who are concerned about
the forthcoming regulation, it is appropriate to
understand the definition is of significance. The
Global Harmonization Task Force has defined Medical
Devices as follows : |
"Medical
device" means any instrument, apparatus, implement,
machine, appliance, implant, in vitro reagent or
calibrator, software, material or other similar or related
article, intended by the manufacturer to be used, alone or
in combination, for human beings for one or more of the
specific purposes of:
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diagnosis,
prevention, monitoring, treatment or alleviation of
disease
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diagnosis,
monitoring, treatment, alleviation of or compensation for
an injury
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investigation, replacement, modification, or support of
the anatomy or of a physiological process
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supporting
or sustaining life
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control of
conception
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disinfection of medical devices
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providing
information for medical purposes by means of in vitro
examination of specimens derived from the human body and
which does not achieve its primary intended action in or
on the human body by pharmacological, immunological or
metabolic means, but which may be assisted in its function
by such means.
Note:
An accessory is not considered to be a medical device.
However, where an accessory is intended specifically by
its manufacturer to be used together with the 'parent'
medical device to enable the medical device to achieve its
intended purpose, it should be subject to the same
procedures and GHTF guidance documents as apply to the
medical device itself.
Note:
The definition of a device for in vitro examination
includes, for example, reagents, calibrators, sample
collection devices, control materials, and related
instruments or apparatus. The information provided by such
an in vitro diagnostic device may be for diagnostic,
monitoring or compatibility purposes. In some
jurisdictions, reagents and the like may be covered by
separate regulations.
Note:
Products, which are considered to be medical devices
in some jurisdictions but for which there is not yet a
harmonized approach, are:
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aids for
disabled/handicapped people
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devices for
the treatment/diagnosis of diseases and injuries in
animals
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spare parts
for medical devices
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devices
incorporating animal and human tissues which may meet the
requirements of the above definition but be subject to
different controls.
This
definition is going to be accepted by most of the
countries including India. Furthermore, Certain components
such as blood tubing and major diagnostic, x-ray
components are considered by USFDA to be finished devices
because they are accessories to finished devices. The
manufacturer of such accessories is subject to the QS
regulation when the accessory device is labeled and sold
separately from the primary device for a health related
purpose to a hospital, physician, or other user. The same
criteria can be applied for the products manufactured in
India.
If you have questions related to
this subject, please write to Dr G L Jain at
drgljain@medisourceasia.com
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Dr G L Jain A Gold Medalist in M. Sc., Dr.
Jain was inclined towards industry right from the
beginning of his career. He joined Shriram Chemical
Industries, Kota as Foreman & thereafter completed Ph.
D. from I.I.T., New Delhi. Dr. Jain got his training
in the field of Pharmaceutical and Medical Devices
through Technical Courses; visiting Manufacturing
units & Laboratories world-over; Regulatory Agencies
like USFDA; Health & Welfare, Canada; BSI, UK;
National Drugs Control Organization, Finland; WHO,
Geneva; CEN; Brussels. He was with USFDA for two
months for training on various aspects of GMP/PMA/NDA
& Inspection.
Besides 17 years in academic institutions like, IIT
and AIIMS, New Delhi, he has hands-on experience of
working in industries for 9 years.
He is an expert on cGMP. In last 15 years, he has
conducted more than two dozen Training Courses on
Quality Assurance & GMP. Amongst his topics of
interest are Building & Premises; Documentation; Clean
Room Concepts; Microbiology & Industrial
Sterilization; Statistical Sampling, Validation and
Quality Management Systems. He has set-up two Medical
Device Manufacturing Facilities. One of the facilities
is certified for WHO-GMP and is a model manufacturing
facility in the country. He has also set up a
Consultancy Service Provider firm ‘ Centre for Active
Learning, Guidance & Solutions’ at Udaipur, India.
He is well known for his high teaching, management,
planning, organizing & leadership capabilities. He has
been Technical Consultant to many industries. |
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