BioSpectrum India Magazine November issue BioSpectrum India Magazine | Page 24

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COVERStory
BioSpectrum
C (moderate high risk) and Class D (high risk). The
manufacturers of medical devices will be required to
meet risk proportionate regulatory requirements that
have been specified in the Rules and are based on best
international practices.
With a view to bring in the highest degree of
professionalism in regulation of medical devices, a
system of ‘Third Party Conformity Assessment and
Certification’ through Notified Bodies is envisaged.
The Notified Bodies will be accredited by the
National Accreditation Board for Certification Bodies
(NABCB). The NABCB will, before accrediting Notified
Bodies, assess their competence in terms of required
human resources and other requirements. These
HIGHLIGHTS OF INDIAN
MEDICAL DEVICES MARKET
 The Indian medical device market has grown
from $2.0 billion (Rs 13,130 crore) in 2009 to
$3.9 billion (Rs 25,269 crore) in 2015 at a CAGR
of 15.8%
 The Indian medical device market contributes
to 4% of the Indian healthcare market which is
pegged at $96.7 billion (Rs 6.29 crore) in 2015
 The medical device market in India can be
segregated into seven distinct categories.
 Diagnostic imaging is the largest segment within
Indian medical device market at $1.18 billion
(Rs 7650 crore) in 2015.
 The other categories comprising of patient
monitors, ECG machines, Defibillators, etc. was
estimated at $0.94 billion (Rs 5,922 crore) in
2015
 Similarly the IV diagnostics market constituted
of $0.39 billion (Rs 2550 crore) in 2015
 Orthopedics and Prosthetics and Consumables
were pegged at $0.90 billion (Rs 5,850 crore) in
2015
 Dental Products and Patient Aids were pegged
at $0.47 billion (Rs 2,961 crore) in 2015
 The import of medical devices has grown from
$2.46 billion (Rs 15,990 crore) in FY 12 to $2.87
billion ( Rs 18,665 crore) in FY 16
 The export of medical devices has grown from
$0.78 billion (Rs 5,070 crore) in FY 12 to $0.98
billion (Rs 6,370 crore) in FY 16
 The total import of medical devices is more
than 75 per cent of total medical devices sales in
India. However, it is estimated that import trade
will fall with increasing number of international
and Indian manufacturer setting up medical
device manufacturing units in India.
Source: Andhra Pradesh Medtech Zone Ltd (AMTZ)
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November 2017
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www.biospectrumindia.com
Bodies will undertake verification and assessment
of Quality Management System of Medical Device
Manufacturers of Class A and Class B category and
may, on as required basis, be called upon to render
assistance for regulation of Class C and D medical
devices also.
The Rules also seek to evolve a culture of self-
compliance by manufacturers of medical devices and,
accordingly, the manufacturing licences for Class A
medical devices will be granted without prior audit of
manufacturing site. The manufacturer will, in such a
case, be required to do self-certification of compliance
with the requirements and based on such certification,
the licence will be issued. However, post approval audit
of manufacturing site will be carried out by the Notified
Bodies to check conformance with Quality Management
System. Manufacture of Class A and Class B medical
devices will be licenced by State Licensing Authorities
concerned after Quality Management System audit by
an accredited Notified Body. For all manufacturing
sites, Quality Management System will need to be
aligned with ISO 13485. Manufacture of Class C and
Class D medical devices will be regulated by the Central
Licensing Authority and, where required, assistance of
experts or notified bodies will be taken. Import of all
medical devices will continue to be regulated by