For the complete report, get in touch with us at: info@netscribes.com The medical device market is a thriving segment of the healthcare industry in India. Rise in the number of hospitals and increasing requirement of healthcare facilities is creating a need for sophisticated devices and equipments which can provide accurate treatment to individuals. The global market is growing rapidly and India has also joined the bandwagon of being one of the fastest growing countries in this respect. The government is expected to develop a regulatory structure leading to quality products by manufacturers. However, the regulatory structure currently lacks active participation from the government but with the increase in competition in the sector, it is due to follow in a very short period of time. Currently, imports account for a large share of primarily the high-end medical device segment and players are gearing up establishing large manufacturing facilities in India to tap the opportunities. The report begins with an introduction of medical devices in India and their classification based on relative parameters set by the Indian Government. The market overview section provides the market size and growth. It also provides an overview of the segments that are existent in the market along with their market share. The import and the export structure of the medical devices in India are also given. This is followed by an analysis of the drivers fueling growth in the market including increasing hospital infrastructure, increasing healthcare spending, changing demographics and growing target consumer group, increasing lifestyle diseases and therapies and increasing medical tourism in India. The key challenges identified include high dependency on exports and lack of standard regulatory structure. The key trends in the market have also been identified including outsourcing/relocating of manufacturing facilities, increasing joint ventures and tie-ups and various exhibitions and trade fairs. The involvement of government in this industry is also included. It shows the role of various government bodies that are involved in regulating this sector and also involved in the promotion of this sector in India. It also highlights the regulations set in terms of assessment of a medical device manufacturing organization in India along with the procedure involved in registration of an organization and procurement of an import license. The initiatives taken by the government in order to promote the sector by providing tax reliefs and import duty relaxations have also been highlighted. The competitive landscape provides a look into the nature of the market, and the active players in the market. A product portfolio matrix is also given to highlight the dominant player in each segments of the market. Profiles of the major domestic and foreign players have been included. Furthermore, key developments in the market over the last one year have also been highlighted.

1. Medical Devices Market – India
August 2010

2. Executive Summary
Medical devices market in India is pegged at INR XX bn in 20-- and is expected to grow to INR YY
Market bn at the end of 20-- with diagnostic equipments being the leading segment
Growing hospital infrastructure and healthcare spending is fostering the need for high-end
devices for accurate and fast treatment
LE
Drivers: Challenges:
Increasing hospital infrastructure Various summits and seminars
P
Drivers & Increasing healthcare spending Initiatives for consumer awareness
Changing demographics and Growing Target Public private partnerships
Challenges
M
consumer group
A
Increasing lifestyle diseases and therapies
S
Increasing Medical tourism in India
Outsourcing/Relocating of manufacturing facilities
Trends Increasing joint ventures and tie-ups
Various exhibitions and trade fairs
Govt. bodies and associations like A1, A2 and A3 are aiming to provide medical devices in India a
Govt. Bodies, regulatory structure in order to promote indigenous production
Regulations & A2 has laid down registration and license regulations to regularize imports of drugs
Initiatives Govt. has provided tax reliefs, import duty relaxations and has implemented major initiatives to
boost the sector in India
The industry has a huge influx of foreign players who have consolidated their operations in India
either through establishing subsidiaries or tying up with Indian distributors
Competition
Players in India are also increasing their manufacturing capacities and are looking at diversifying
their product quality and portfolio
MEDICAL DEVICES MARKET IN INDIA 2010.PPT 2

3. •Introduction
•Market Overview
•Drivers & Challenges
•Trends
•Government Involvement
Government Bodies
Government Regulations
Government Initiatives
•Competition
•Key Developments
MEDICAL DEVICES MARKET IN INDIA 2010.PPT 3

4. Medical Devices are classified as per the risk level and their
intended use
PLE
•Medical devices under the meaning of Section 3 (b) (iv) of the L refers to:
M
Any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software,
material or other similar or related article which is:
A
– intended by the manufacturer to be used alone or in combination for human beings for one or more specific purposes of diagnosis,
S
prevention, monitoring, treatment or alleviation of disease and,
– which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic
means, but which may be assisted in its intended function by such means
Medical Devices in India are classified as per their risk levels and intended use . They are divided into classes and the classification
is carried out in accordance with Annex IX of Schedule M-III provided by A1
Class A Class B Class C Class D
Low Risk Low-moderate Risk Moderate-high Risk High Risk
• Contains devices like P1, • Contains devices like • Contains devices like • Contains devices like
P2, P3 and P4 PB1, PB2, PB3 and PB4 PC1, PC2, PC3 and PC4 PD1, PD2, PD3 and PD4
• Cannot commence • Can commence clinical • Can commence clinical • Can commence clinical
clinical investigations investigations investigations investigations
immediately after the immediately after the immediately after the immediately after the
date of information and date of information and date of information and date of information and
submission to A2 submission to A2 submission to A3 submission to A4
If a manufacturer desires to reclassify a device to a lower class, it must submit justification to A2 for evaluation that the
movement to the lesser stringent class will assure sufficient safety & effectiveness of the device
MEDICAL DEVICES MARKET IN INDIA 2010.PPT 4

5. India's medical device market is currently the T largest
market in Asia and ranks among the world’s top P
Market Overview Market Size and Growth
• Good healthcare infrastructure, population rise and
INR bn
growing economy are fueling growth in the medical
equipment market 100 a% YY
• There are some 700 medical devices makers in India 80
LE
Most of them make low-value products such as needles, XX
60
syringes, catheters, blood collection tubes, medical
40
P
electronics and implants
High-end specialist products are catered by foreign firms 20
AM
• India requires major foreign participation, especially
in high-tech devices that account for roughly 45-55%
S
of the entire market
Currently, most of the reputed Indian healthcare institutes
use foreign medical equipments for the purpose of
0
2009
Segmentation of Market
2010e
surgery, diagnosis of cancer and imaging s5% Segment 1
• Currently, according to the new guidance, all s4% Segment 2
medical devices sold in India must carry the ICAC s1% Segment 3
mark (Indian Conformity Assessment Certificate) to Segment 4
indicate their conformity with the provisions of this Segment 5
schedule to enable them to move freely within the s3%
country
s2%
Source:
MEDICAL DEVICES MARKET IN INDIA 2010.PPT 5

6. Drivers & Challenges – Summary
Drivers
Increasing hospital infrastructure
Challenges
Increasing healthcare spending High dependency on exports
Changing demographics and Growing
Target consumer group Lack of standard regulatory structure
Increasing lifestyle diseases and
therapies
Increasing Medical tourism in India
MEDICAL DEVICES MARKET IN INDIA 2010.PPT 6

7. Trends – Summary
Outsourcing/Relocating of
manufacturing facilities
Key
Trends
Various exhibitions and Increasing joint ventures
trade fairs and tie-ups
MEDICAL DEVICES MARKET IN INDIA 2010.PPT 7

8. •Introduction
•Market Overview
•Drivers & Challenges
•Trends
•Government Involvement
Government Bodies
Government Regulations
Government Initiatives
•Competition
•Key Developments
MEDICAL DEVICES MARKET IN INDIA 2010.PPT 8

9. The efforts of A2 have provided areas of improvement in
medical devices sector of India
A2 A3
Serves as the main regulatory body for
• It is the authority regulating medical devices in India medical devices that will classify medical
devices, and any manufacturer seeking a
LE
under A1
less stringent classification must justify it to
• It lays down rules, standards and approves import and the A2
P
manufacturing of T1, T2, T3 and T4
• Establishes standards and regulations for R1, R2, R3, R4, R5, R6
M
and R7
Act and Regulatory status of A2
A
• Companies must register all their products with the A2
S
before its products can be introduced into the Indian
market
• It issued a Gazette Notification S.O. 14-- (20--) that
declared L categories of sterile devices to be considered
A4
Regulates the import, manufacture, sale,
as drugs under Section 3 (b) (iv) of the Q Act distribution of X medical devices classified
• In late 20--, A3 (DCGI) prepared an expanded list of as drugs and also provides licenses which
are compulsory for the importers and
medical devices which require registration manufacturers to deal in the said devices
• The list now includes over X medical devices
• Currently working on a road map to include current
A2 has also adopted and recognized BIS YY or its
status review as well as guiding principles of medical
revisions & ISO KK in respect of the specifications
devices and a regulatory process implementation phases to be followed for quality in order for the
to make it an all inclusive process manufacturer to demonstrate conformity with the
relevant regulatory requirements
Source:
MEDICAL DEVICES MARKET IN INDIA 2010.PPT 9

10. Segmentation of Players (1/2)
Electronic
Diagnostic Surgical Imaging
Players treatment Others
Equipment Equipment Devices
Devices
Domestic Players
Player 1
Player 2
Player 3
Player 4
Player 5
Player 6
Player 7
Player 8
Player 9
Player 10
Player 11
Player 12
Player 13
Player 14
Player 15
Source:
MEDICAL DEVICES MARKET IN INDIA 2010.PPT 10

11. Major Domestic Players (1/12)
Company Snapshot: Company 1
Corporate Information Financial Performance
Revenue
Headquarters XX Revenue Profit
INR mn Profit / Loss INR mn
Founded 19-- 600 R1
R4
40
R2 R3
30
400
Products Product 1, Product 2 and Product 3 20
200
10
Key People NA 0 0
2005-06 2006-07 2007-08 2008-09
Business Highlights
• It provides products and services in information technology and healthcare sectors in India
PLE
• Its healthcare division provides medical equipments to critical care, trauma, and operation theatre areas in the
hospitals; develops specialty critical care/trauma care ambulances; manufactures and supplies of mobile medical
units for diagnostics; and undertakes turnkey projects for providing customized solutions for construction of modular
• Operates as a subsidiary of Company K
S M
operation theatres, surgical pendants, and intensive care units
A
• Its customer base includes major corporates, defense establishments, software technology parks, MNC's and Super-
specialty hospitals
Source:
MEDICAL DEVICES MARKET IN INDIA 2010.PPT 11

12. Thank you for the attention
The Medical Devices Market report is part of Research on India’s Healthcare Industry Series.
For more detailed information or customized research requirements please contact:
Gagan Uppal Gaurav Kumar
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