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Expert
Presentation 4
Shri Rajiv Nath
Managing Director, Hindustan Syringes & Medical
Devices Ltd & Forum Co-ordinator - AiMeD
Indian Certification For Medical Devices : ICMED
Certification |
Mr Rajiv Nath highlighted the need
to have smooth and well defined regulatory pathway for
the industry to have smooth transition. Well defined
and implemented regulatory framework will enable the
ease of doing business for the industry too. Industry
will attract fresh investments into the sector only if
there is a well defined and clear regulatory
framework. Lack of well defined regulatory environment
is the reason why med dev industry did not attract
investments into this segment over the last 10-20
years. Mr Rajiv Nath has recalled how the regulatory
framework in the country has evolved since 1989 and
how the changes were taking place in regulatory space.
He highlighted the need to encourage Make in India and
not to discourage investments in this sector and this
is possible to have more clarity and well defined
regulatory structure. Med Dev Industry has welcomed
the Regulations and always is of the opinion that well
defined regulatory mechanism will attract investments
into this sector. He touched upon the need to separate
laws for Drugs , Devices and Cosmetics to bring more
clarity while addressing patient safety issues. He
touched upon the need to share the work load betn
Central Govt, State Govts and the Conformity
Assessment bodies to have an effective implementation
roadmap. He emphasised upon the need to create
laboratory infrastructure in the country to test all
med dev in the country. All these have to be on place
before the regulations get rolled out. Mr Nath
highlighted about the ICMED Certification, an Indian
Certification Standard created in alignment with
International Standards requirements, 5 years ago by
involving multiple stakeholders including MoH&FW.
ICMED Certification was designed as a Voluntary
Standard and mfrers implementing ICMED Certification
meets compliance to MDR 2017 automatically and many
more patient safety standards and other elements as
well. Mr Nath concluded his speech with a wish list
from the industry which includes bringing all mfrers
and importers under registration mechanism by CDSCO;
compliance to ISO/IS13485 Certification by industry
and importers in next 2 years time; to incentivise
QCI’S Voluntary ICMED Certification; Build competence
of Auditors, Med Dev officers & Mfrers; create testing
infrastructure with more NABL Accredited labs;
expedite adaption of ISO Stds as BIS Stds; creating
separate law for Medical Devices. |
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Expert
Presentation 5
Dr Sanjeev Kumar Gupta
Managing Consultant, InTrust Consulting
Indian Medical Device Rules – Transition Period
and Industry Preparedness |
Dr Gupta started off his speech by
highlighting the need for med dev industry to prepare
for the transition to regulatory regime and why
industry should be prepared to spend both time and
money on this exercise. He cited how challenging this
exercise would be for MSME businesses to meet the QMS
& Regulatory Spec but why its inevitable as the mfrers
have responsibility to produce both Quality and Safe
products. He stressed upon the need for the top mgmt
to keep aside good budgets for MDR & QMS
implementation as budgeting is also an important
exercise for the industry to have an effective roadmap
towards implementation. As a Regulatory Planner and
Consultant, he has listed out the regulatory
compliance roadmap for various segments of industry.
He has listed out the key challenges in implementing
the regulatory reqts in terms of infrastructure, QMS
implementation and upskilling of human resources. He
has also listed out the challenges in implementing Sch
4 requirements on MDR which calls for Technical
Documentation. He has concluded his speech by sharing
some tips to the industry on execution roadmap and
do’s and don’t’s suggestions too! |
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Expert
Presentation 6
Mr M G Sathyendra
Founder & CEO, Q Mart Global
Global Medical Device Regulations |
Safety matters and why Regulations
in Med Dev space aim at addressing the same. He cited
how regulations help to arrest the import of sub
standard products into the country , which otherwise
may put patients lives to greater risk. He touched
upon the various stages of govt regulations that
industry is subject too. He touched upon the common
framework for regulations .He shared the regulatory
systems in GFTF Countries and the role of IMDRF
(International Med Dev Regulatory Framework). He
discussed about the Med Dev classification and how it
differs in global environment. He discussed about key
regulatory requirements in key global markets . He
also touched upon the role of Standards in the global
regulatory regime and finally concluded the session by
sharing the list of indispensable standards applicable
for med dev industry across the globe. |
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Conclusion And Vote Of
Thanks
Mrs Rama Venugopal
President, Consultants Consortium Of Chennai
Mrs Rama Venugopal,
President, Consultants Consortium of Chennai has
concluded the session with a vote of thanks by
thanking all partners and sponsors for the session. |
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