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Quality Certifications In
Medical Device Sector
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Anil Jauhri -
Ex-CEO,
National Accreditation Board for Certification Bodies (NABCB) |
Introduction:
The WTO regime, through the Agreement on Technical
Barriers to Trade commonly called the TBT Agreement,
recognizes that member nations may need to impose
technical regulations, loosely standard enforced by law,
on grounds such as health, safety, environment,
deceptive trade practices and national security. This
would mean that medical devices are readily amenable to
regulations on grounds of patient safety and health.
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Unfortunately, India has not paid due
attention to medical device industry allowing it to remain
unregulated for a long time and its only in last 5 years that
serious action to regulate them has been taken by CDSCO. The
notification of Medical Devices Rules, 2017 was one milestone;
abandoning the approach of notifying individual devices by
notifying a definition of medical devices with effect from 1
Apr 2020 is another significant step forward. The industry
currently is in transition before regulations begin applying
from 1 Oct 2021.
Role Of Certification In Regulation
Certification, whether process, product or
system, is usually a voluntary activity unless notified by the
regulators. Regulations normally rely on inspection, audit
and/or testing activities for checking compliance to laid down
standards.
India is one of the few countries where
concept of mandatory BIS certification has been used in many
products – cement, steel, bottled water are just a few
examples of such an approach which may not be the best
approach as far as regulation of industry is concerned – its
more cumbersome and expensive affecting the competiveness of
Indian industry.
Rightly, the MDR, 2017 does not require
certification although it prescribes compliance to BIS
standards as the first choice. It instead prescribes audit by
the notified bodies for class A and B devices and by the
regulator for class C and D devices with an option that
notified bodies could also be used for class C and D
device industry.
Why Certification
The question then arises that if regulation
does not require certification, what would be its need or
relevance once MDR, 2017 becomes fully applicable by 1 Oct
2023.
The immediate answer is that while
notifying compliance to MDR, 2017 under the new definition of
medical devices, CDSCO has also notified a transitional phase
in which industry has been given time to voluntarily register
and one of the conditions prescribed is that they should have
an ISO 13485 certificate by a certification body accredited by
NABCB, the national accreditation body, or any IAF member
accreditation body like UKAS I UK, or DAKKS in Germany or ANAB/IAS/UAF
in USA.
Therefore all medical device manufacturers
have to initially go for ISO 13485 certification which
otherwise is voluntary.
The next question could be that if MDR,
2017 does not require certification, what would be the value
of such ISO 13485 certification post implementation of MDR,
2017.
The answer is that any manufacturer
certified to ISO 13485 would be allowed a reduction in audit
time for the purpose of audit by the notified body under MDR,
2017 since QMS prescribed under Fifth Schedule of MDR is
broadly aligned with ISO 13485.
Further, since ISO 13485 is an
international standard and is directly or indirectly
referenced in most regulations around the world, certification
to it is an excellent way to demonstrate compliance to it with
an internationally acceptable certificate. Any medical device
manufacturer eyeing the overseas market would be well advised
to continue with ISO 13485 certificate to enhance his
credentials.
Risk of Unauthentic Certificates
The world market is full of private
certification bodies issuing certificates to industry and it
is important to distinguish an authentic certificate from many
unauthentic, fake or even fraudulent certificates going
around. Unfortunately, there is a plethora of unauthentic
certificates in the medical device sector which should get
weeded out with the stipulation of accredited certificate
under IAF system by CDSCO for voluntary registration.
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