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"Association of
Indian Medical Device Industry (AIMED)" Launched
Announcement of an Umbrella
Association of Indian Medical Device Industry was made
during the first formal meeting held at Indian Habitat
Centre, New Delhi on Dec. 20, 2008.
A Regulatory Review Informal Broad Based Organization as
interphase with AHWP (The Asian Harmonization Working
Party) and GHTF (Global Harmonization Task Force) was also
formed during the meeting.
Approximately 60 representatives from 40 industries -
Orthopedic, Ophthalmic, Syringes, I.V. Cannula, Wound
Dressing, Shunts, Drapes, Electrodes, Gloves, Anesthesia
equipments, Cardiovascular & 4 MNCs were present
additionally the ones from Conformity Assessment Bodies
like BSI, DNV, TUV and Intertek. Another 35 Nos. members
currently have shown their interest in joining the
Association but who could not attend the meeting.
Mr. Rajiv Nath, meeting Coordinator & President of AISNMA
(All India Syringes & Medical Devices Ltd.) welcomed all
participants and briefed the need for such a collaborative
body to work on the lines of EUCOMED or AAMI.
Explaining the background of this development, Mr. Rajiv
Nath, Meeting Coordinator & President of AISNMA (All India
Syringes & Medical Devices Ltd.) mentioned in the minutes
circulated to the members that the Medical Device Industry
is highly upset with the Government and that there is no
administrative Ministry wanting to promote growth of this
sector of the Industry. The Ministry of Science &
Technology and Ministry of Health both want to regulate
without bothering about the growth of industry in this
sector. The industry needs to create a forum to cover
common issues of the stakeholders. He further mentioned
that the need for such a collaborative body is to work on
the lines of EUCOMED or AAMI.
This was initiated on informal suggestions by a few well
meaning individuals to have this Umbrella
Association. The idea is to complement the role of
existing work being done by those focused and well meaning
associations and not displace them. It was felt that while
CII and FICCI were doing similar work and also AMCHAM and
ADVAMED ,the majority of the industries are outside these
4 forums for various reasons. One reason is that these
forums at most times don’t communicate/involve the
majority of the industry falling outside their membership
resulting in growth of fragmented multiple associations.
The Umbrella Association will ensure convergence and a
single platform, when needed, for ensuring overall growth
of Indian Industry. The Umbrella Association in any case
will address the needs of all members of the Medical
Device Industry irrespective of their affiliation or their
company size. It will also help in wider dissemination of
information to each player of the industry. One more
reason was that due to prohibitive membership fees and
annual fees, smaller Companies feel discouraged to join
and feel even if they did that, their voice/grievances are
over looked by large established players and sponsors with
more financial clout driving their company specific
agenda.
The name "Association of Indian Medical Device Industry
(AIMED) was chosen for the Umbrella Association of
Medical Device Industry.
It was decided that the structure would be horizontally
divided into common groupings like "Legal Issues, Tax
Issues, Export Related Issues, Medical Device Regulatory
Issues common to all vertical groups of different families
of product lines with Zonal Representations. The structure
and the secretariats will be formalized at the next
meeting.
"Indian Medial Device Regulatory Review Group (IMDRRG)
was also formed with an view to bring Regulator, Regulated
and CAB to the same forum for informal review of the
Regulations and to keep this review on going and dynamic.
Mr Nath introduced the concept of AHWP, Malaysia and said
that while the AHWP can’t be replicated in its entire
current form but idea is to replicate whatever can be done
for the Indian context. He mentioned that the request
initially came from Senior Officers in the MOH. They could
see conflict of interests and agenda from various groups
and were interested in a more unified and harmonized
approach by the industry. They wanted to see the growth of
Indian Industry.
The idea is not to have an adversary Communication of the
AIMED with the Regulators sitting on opposite side of the
table but based on the idea of the AHWP where all stake
holders - Industry, MOH Regulatory Officers and
representatives of the Conformity Assessment Body sit on
same side of the table and go through the learning and
implementation process together. It was felt that this
will bring around more informal communication and a forum
to appreciate each others opinion or voice opinions, get
better conceptual understanding of the various aspects of
regulation and
strive for harmonization.
While debating the advantages for the forum it was
recommended that representatives from Test Laboratories
and QA System Consultancy Organizations and WHO in
addition to Regulators may be invited to use this forum
for training, discussion and on going regulatory
implementation review to enable education of the industry
and the regulators.
Various subgroups were formed covering Indian medical
device industry sub-groups which included Orthopedic,
Ophthalmic Industries, Diagnostic and Would Care
Industries.
The Orthopedic group would work on a draft proposal to be
sent to the regulators by the AIMED to register all these
industries and thereafter on issuance of guidelines start
the licensing regulation process..
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