
Highlights based on presentations given by Industry
Experts
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Compiled by
Mrs. Rama Venugopal,
President,
Consultants Consortium Of Chennai
Day 4 Webinar was created
for Medical Device Industry on Standards,
Certifications and Regulations. The Session was
scheduled on Dec 17th from 4 – 6 pm and was attended
by Med Dev Industry players and various stakeholders
of the industry.
Program started off with
opening remarks by Dr Usha Jain and Shri D L Pandya,
Expo Organisers and thereafter was moderated by Dr
Sanjeev Kumar Gupta and Mrs Rama Venugopal from
Consultants Consortium of Chennai, the Conference
Organisers. |
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Key Note
Address By
Dr.
Ravikant Sharma
Deputy Drug Controller, CDSCO
“Towards a World Class Regime”
Session started off with a key
note speech Dr Ravi Kant Sharma, DDC, CDSCO. |
Dr Sharma briefed the industry
about commitment shown by CDSCO in issuing licenses to
the industry even during covid times in about a week’s
time to all applicants. CDSCO is committee to work
along with the industry to make industry focus on
making India Self Reliant in med dev mfrg space. He
mentioned that CDSCO currently is regulating only 24
categories of medical devices and all med dev come
under Regulation as per the mandate of MoH&FW.
Currently , the Regulator has only called for
Voluntary Registration of all Med Dev in the country
as to understand who is manufacturing what products in
the country ! This is purely a voluntary registration
process before mandatory licensing kick starts.
Industry is currently under transition phase towards a
regulatory regime. Dr Sharma has explained that Class
A and B devices are given a 12 + 18 months timeline
before they come under licensing regime & Class C and
D devices are given a 42 months timeline to be ready
before mandatory licensing starts. He also clarified
that Voluntary Registration doesn’t mean Licensing. He
also explained about need to have Licensing audits for
Class C & D Categories inspite of having ISO
Certificates as this is linked to post market
surveillance requirement. He also asked the mfrers to
apply for license for products notified in Jan 2020
notification so that they can issue the licenses soon.
Rest of the session had series of
speakers covering wide range of topics as follows : |
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Expert
Presentation 2
Mr. Jayanta
Roy Chowdhury
Scientist G & DDG - Standardisation-
Products & Methods, Bureau of Indian Standards.
"Quality & Safety of Medical
Devices & Emerging Focus on Technical Standards" |
Mr Chowdhury has touched upon the
process of standardization of Medical Devices. He
mentioned that BIS has created structure for medical
equipments and hospital planning division council
which comprises of 20 sectional committees (with 650
experts), 3 sub committees, 2 panels. BIS has so far
published 1380 Indian Standards & 465 Standards
harmonized with ISO/IEC. He spoke about the Standards
National Action Plan which was rolled out by BIS based
on the Indian National Strategy for tandardization
initiative launched by Govt of India.
1st step towards the
Standardization kick started with the HITES List of
Commonly procured Medical Devices List from MoH&FW
which had a list of 455 items. BIS has published 282
Standards for devices from this list and work in
progress for about 81 devices, work yet to start for
about 56 high risk devices.
Major ongoing standards
devt exercise is happening currently for IVD devices,
High Risk Devices, Class D Medical Devices, Surgical
Instruments, Cold chain equipment, cyber security of
connected medical devices, biomedical waste
management, telemedicine and telehealth standards.
Niti Aayog entrusted BIS with the task of developed
standards for Priority Assistive Devices. BIS is
taking active part in ISO/IEC International
Standardization Work.
BIS is inviting any
stakeholder to submit proposal for development of
Standards and to comment on the draft standards
published online. It also proposing creation of
Standardization Cells in Industry Associations
for better industry collaborations. |
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Expert
Presentation 3
Mr. Anil Jauhri
Ex CEO – NABCB
Global Limelight on Authentic
Certifications – an outcome of Pandemic Effect |
Med Dev Industry is regulated
across the globe and in India too Med Dev for
healthcare is brought under Regulation. Covid 19 has
exposed that global markets are also flooded with
unauthentic QMS & Product Certificates similar to
Indian experience. Market place needs an assurance
that these certificates are genuine and reliable.
Certification business is voluntary in Indian market
and currently there is no regulation of these bodies
and no single point of control to monitor their market
practices. Anyone can set up a certification body and
there is no legal bar too. Certifications are
generally voluntary in nature and are driven by market
demands, buyers demand etc and not because of
regulatory push alone. ISO 13485 is the globally
recognised Quality Management Systems Std for Med Dev.
Indian MDR has mandated compliance to QMS but not
mandated ISO 13485 in the Rules. However, during the
curent transition phase (towards mandatory
regulation), MDR has asked for compliance to ISO 13485
Std as prerequisite for Voluntary Registration
process. However its only optional. But for the
Certification programs of BIS – ISI Mark or QCI-AIMED
driven ICMED Certifications, all other Certifications
are done by Pvt Bodies in the market place. So a
natural question that arises to our minds is the kind
of certificates issued by these private bodies ! These
fall under 2 categories – Authentic and Unauthentic
Certificates. Mr Jauhri has demonstrated how these
certificates look and how to identify both, by
following simple steps. Accreditation of Certification
Process is the internationally recognised way for
improving the market confidence and hence
IAF has a strong role to play. Authentic
Certificates generally carry IAF logo but not
mandatory though ! Mr Jauri raised a question to the
Regulator and Industry to clarify too – MDR calls for
compliance to QMS spec mentioned in Sch 5 and not
mandated ISO 13485. So what will happen to ISO 13485
Certifications when industry gets into Regulation
mode. This question needs an answer from the Regulator
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