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Medical Device Industry : Regulatory Reforms
The Medical Device regulatory process is passing through the transition phase
now with few units having already received manufacturing licences but a large
number of units, having already applied , are either awaiting the licence and a
good number still in a state of confusion.
The formation of “ The Indian Medical Devices Regulatory Review Group”, IMDRRG
and lauching of All India Medical Device Manufacturers’ Association, ( AIMED )
is a welcome change in the status quo which was existing since long.
On the part of Medical Device Companies , it will be of great help to the Indian
Medical Device Industry in general and the individual units in particular to be
participative in the process. |
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Mr Rajiv Nath , forum co-ordinator , Association of
Indian Medical Device Industry (AIMED) And Managing Director, Hindustan Syringes
& Medical Devices Limited. in his presentation made during the “Conference On
Indian Medical Devices & Plastics Disposables Industry 2009 “ held in Feb 2009
in Ahmedabad ( abstract reproduced in this issue ), very lucidly , presented
minutest details regarding the developments.
The presentation focused on issues related to Medical Device Regulations :
the previous situation , what it is currently undergoing and what changes are
expected in the future. He also shared his VISION for the future of the Indian
Medical Device Industry .
Sharing his vision for the furure of Indian Industry , Mr Rajiv Nath said that
we must continue to upgrade our manufacturing and testing facilities, management
competencies and also put in place the right quality management systems.
India has already become the top 5 preferred source status for syringes,
needles, IV catheters, contraceptives, blades, gloves, intra ocular lens. For
most of these items anything from 25% up is now India’s supply capability. For
many of these items, we have now become a dominant player or a serious player in
the International market and the manufacturing units are looked at with respect
outside India also.
To the Regulatory Authorities , his message is ,”Please understand the
difference between Pharmaceuticals and Medical Devices”. There are more than
1000 medical devices which are made in the country. Unfortunately whenever they
are brought in to the purview of the regulations, they have been treated as
drugs and pharmaceuticals.
The regulatory framework for the pharmaceuticals industry in India is very good
. His vision is to have something similar for the Medical Devices.
This issue also covers two more important medical device manufacturing issues.
Dr G L Jain has described the “Quality Assurance Concept In Medical Devices”
and Dr Narendra Deshmukh has also discussed the important aspect of
"Safety Assessment of Medical Devices and GLP Compliant Studies”.
Last but not the least, we, very sincerely thank the Indian Medical Device
Industry for their participation in the “Conference On Indian Medical Devices
& Plastics Disposables Industry 2009”. We look forward to your continued
participation in the next Conference which will be held in February 2010.
D.L. Pandya
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