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TÜV SÜD becomes first certification body in India to be accredited by NABCB for certifying medical devices organizations
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Our Bureau, Mumbai
March 11 , 2017
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Globally acclaimed German safety and quality expert, TÜV SÜD, received
accreditation from National Accreditation Board for Certifying Bodies
(NABCB) to grant certifications for ISO 13485, ICMED 9000 and ICMED
13485. NABCB is a part of Quality Council of India (QCI). TÜV SÜD is the
first and only independent certification body till date in India to be
accredited by NABCB to issue these certifications.
ISO 13485
specifies requirements for a quality management system that can benefit
an organization right from design to practical usage of medical devices
and related services. ICMED 9000 certification comprises of ISO 9001
plus additional requirements, whereas, ICMED 13485 includes ISO 13485
plus additional requirements. These certifications are covered under the
ICMED (Indian Certification for Medical Devices) Scheme, which was
introduced by the Quality Council of India with an aim to bring down
cost and turnaround.
TÜV SÜD will also offer the unique MDSAP
(Medical Device Single Audit Programme). The programme aims to help
manufacturers get their devices into multiple global markets through a
single audit.
Commenting on the accreditation, Suresh Kumar, Vice
President, Product Services TÜV SÜD South Asia said, “It is an honour
for us to be the first certification body in India accredited by the
NABCB to issue ISO 13485 and ICMED certifications. Global quality
regulations for medical devices are among the most stringent as they
safeguard patient interests. The ICMED Standard that TÜV SÜD offers is
poised to build credibility of the manufacturers, secure user confidence
that will subsequently uphold brand reputation. With our MDSAP
services, we aim to provide manufacturers credibility, motivate them to
increase their export footprint, empower them to gain easy access to
exports and align with the government’s ‘Make in India’ programme.”
In
one of the most significant policy shifts this year, the government
decided to move the medical device industry out of the pharmaceutical
sector which has lent easy accessibility to important medical devices.
These quality standards will help identify and eliminate trading of
substandard quality of devices, thereby protecting patients from
imminent harm. Industry reports suggest that India contributes just over
1.3% to the USD 335 billion global medical devices market. Only 5% of
the 750 medical device manufacturing firms in India have established
significant presence in export markets.
TÜV SÜD’s ISO 13485;
ICMED13485 & ICMED 9000 program adheres to guidelines as per ISO
17021: 2011 and ISO 17065: 2012 for certification bodies providing audit
and certification of management systems.
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