http://www.prnewswire.co.

uk/news-releases/research-and-markets---global-in-vitro-
diagnostics-market-2017-2023-roche-diagnostics-siemens-621861143.html

IVD is expected to increase to $76 billion by 2023 and increase

its influence over healthcare spending globally.

https://www.trivitron.com/blog/5-reasons-why-india-will-soon-
become-a-global-leader-in-high-quality-affordable-diagnostic-
solutions/

Number predictions An unimaginable growth is possible

The Indian diagnostics market can be broadly classified into
equipment, reagents, and services. Even though the service sector
is cluttered, major healthcare players in India grouped and clustered
it in tier 1 and tier 2 cities. Lets closely examine the numbers under
the magnifying glass.

The size of the Indian In Vitro Diagnostics (IVD) market

531 Million USD in 2011(Source: McEvoy & Farmer 2011)
900 Million USD by 2016 (Source: Frost and Sullivan)
32 Billion USD by 2022 (Source: Business Insider)

The Diagnostic Services Market is expected to continue its

growth at 27.5% for the next 5 years

Untapped potential eCommerce

Even though the numbers look healthy, the diagnostic industry still
has untapped potential, for instance eCommerce. In India, if the
major eCommerce players adopt the diagnostic market, the industry
can be regulated and soon it will develop an immense potential to
grow further. Factors like the ease of use, convenience, doorstep
delivery, online payment, cash on delivery and other multiple
options will contribute enormously to this growth.

Likewise, if more and more major players adapt to this eCommerce

way of doing business by developing their own eStores, they can
mint revenues easily. Soon, this can be expanded to other
healthcare services like medicines, home care services,
ambulance, etc.

Initiatives by the Government

The Indian government, on its part, is promoting the sector with the
help of positive regulations such as Health bill. This aims to bring
the independent bodies like the Medical Council of India (MCI),
Dental Council of India (DCI), Pharmacy Council of India (PCI) and
the Nursing Council of India (NCI) under one umbrella to function
together for better results

Infrastructure Development
The infrastructure development in the Indian healthcare industry
has been indirectly helping the diagnostics market of India to boom
to some magical figures. With a compound, annual growth rate
(CAGR) of 18.1 percent from 2009 to 2016, IVD has emerged as
one of the most profitable markets in the Indian healthcare industry.
Enhancements in the corporate hospital infrastructure and
installation of automated and semi-automated biochemistry,
immunology, and hematology equipment have enabled the market
to achieve this healthy growth rate.

Even niche sectors like lifestyle and communicable diseases are no

longer restricted to urban areas, as they are now accessible to both
suburban and rural areas. Most of the patients are now even visiting
health centers outside their village for diagnosis and treatment.
These changes such as, higher healthcare spending, better R&D,
rising incidence of diseases due to population are now forcing the
leading healthcare providers to reach out to patients in tier III cities
and rural areas.

Aggregating the fragmented Diagnostic Sector

Even though the leading healthcare providers are expanding their
realm, it will be difficult for the healthcare companies to cater to
them as the IVD market in India is highly unorganized and
fragmented. The major reason for this fragmentation is the
providers inability to go through the low entry barriers. It also gives
room for complete lack of standardization when it comes to labs in
rural India. Stats reveal that only 150-200 laboratories in India have
proper accreditation and their lack of legislation, standardized
procedures and equipment.

To address this demand for quality healthcare, several corporate

laboratories and healthcare providers are stepping up by introducing
cost-effective and convenient patient care packages. Various
schemes like Make in India, relaxations in the manufacturing cost
will now allow the manufacturers to provide the diagnostic solutions
in a much affordable manner.
http://www.medicalbuyer.co.in/index.php/invitro-diagnostics/invitro-
industry/6601-in-vitro-diagnostics-market-to-grow-at-5-5-percent

The global in vitro diagnostics market is estimated at USD 60.22 billion in 2016.
This market is expected to grow at a CAGR of 5.5 percent during 2016 to 2021 to
reach USD 78.74 billion by 2021, states Markets and Markets. The growing
acceptance of molecular diagnostics in personalized medicine, increasing
prevalence of lifestyle and chronic diseases, and growth in the number of private
diagnostic centers are key factors driving market growth. Untapped emerging
regions showcase new growth opportunities for this market. However, market
growth is restrained by the lack of reimbursement and increasing healthcare cost.
On the basis of application, the market is segmented into diabetes, infectious
diseases, oncology/cancer, cardiology, HIV/AIDS, autoimmune diseases,
nephrology, drug testing/pharmacogenomics, and other applications. In 2016, the
infectious diseases segment accounted for the largest share of the IVD market.
The large share of this segment is attributed to the rise in the incidences of
various infectious disorders such as tuberculosis (TB), hepatitis, and hospital-
acquired infections which fuel the demand for IVD tests. The oncology/cancer
segment is expected to register the highest CAGR during the forecast period due
to the growing incidences of cancer forms that stimulate the demand for early
detection of the disease.
In 2016, North America accounted for the largest share of the IVD market,
followed by Europe. Factors like easy accessibility to technologically advanced
products and presence of a large number of leading IVD manufacturers in the
region are driving market growth in North America. Similarly, the rising prevalence
of chronic lifestyle and genetic diseases, rising geriatric population, increasing
acceptance of personalized medicine, and growing adoption of technologically
advanced products are driving the growth of the North American IVD market.
The Asia-Pacific region is expected to witness the highest growth in this market
majorly due to improving healthcare infrastructure and growing economies in
China and India. In addition, manufacturers are increasingly focusing on
strengthening their presence in emerging APAC countries.

http://www.developmentnews.in/india-ivd-sector-scaling-next-growth-trajectory/
The invitro diagnostics (IVD) market in India is growing at a phenomenal
pace and the country has the potential to emerge as a global
manufacturing hub in the medical devices space. India is the fourth
largest market for IVD devices in Asia after China, Japan and South
Korea. Demand for personalized medicines, innovations in diagnostic
techniques, increasing preference for point-of-care testing among the
general population, a growing geriatric population base and increase in
disposable incomes is driving the growth of the IVD sector in India.
Increasing proliferation of lifestyle ailments like heart disease and rising
awareness of minimally invasive and non-invasive diagnostic techniques
have emerged as positive triggers for positioning India as a rapidly rising
market for IVD devices. The demand for clinical chemistry products is
anticipated to be vastly bolstered by advances in self-monitoring
methods for diabetes and patient screening techniques along with the
increasing use of point-of-care systems which offer greater diagnostic
accuracy. The molecular diagnostics products market is expanding
rapidly as they possess higher precision and allow for speedy detection
of infectious diseases and genetic disorders at an early stage of
development.
Advances in surgical techniques, emerging trends in emergency
diagnostics and evolutions in patient care systems point to the fact that
hospital laboratories would be the key determinants in deciding the
designing and marketing strategies of IVD makers. Clinical laboratories
will also form an important client base for the countrys IVD sector with
the need for revamped devices and testing capabilities. The rapid growth
in the home healthcare segment is also set to govern the parameters on
which IVD players would position their product portfolios.
Global IVD companies are expanding their operational footprint in India
which presents a growing market for their products like ready-to-use test
kits equipped with features like high specificity and acute diagnostic
analysis. There is a growing need for advanced diagnostic products
which include sequencers and molecular test analyzers for servicing the
rapidly rising rural healthcare sector.
The medical devices industry in India is still in a nascent stage and its
efficacies are largely restrained by a fragmented structure and its import
centric nature. The Indian IVD sector comprises small and medium
players who have a limited R&D budget and whose manufacturing
capabilities are limited to making low-cost high-volume products like
medical disposables. The demand for high-end test kits and tubes is
broadly sourced by imports from global MNCs. There is an urgent need
to broaden the contours of the ambitious Make in India program of the
government of India and make it a commendable tool for bolstering the
manufacturing efficacies of the Indian IVD industry and indigenize its
capabilities.
The Indian government has taken positive steps to boost the capacities
of the domestic IVD sector. The formulation of the Medical Devices Rule
2017, which will come into effect from January 1, 2018, is a key measure
which will direct investment inflows in the sector and reduce the
production cost of devices, whose benefits, in turn, can be passed on to
the end user. The healthcare sector is likely to receive a flurry of
investments with the government considering coming out with a new FDI
policy.
The government needs to provide a level-playing field to domestic IVD
manufacturers vis--vis their global peers by removing the anomalies in
inverted duty structure and reducing the tariff on raw materials. Stake
holders across the healthcare supply chain should be involved in
conceiving policy measures and creating a viable incentive structure that
will increase investment volumes in the sector and promote innovation
and technical advancement. Greenfield manufacturing units and new
age startups should be encouraged to scale their capabilities through
extension of financial incentives in the form of tax holidays. These
measures will ensure that there is a wider outreach of healthcare sector
benefits, especially state-of-the art IVD products, to a larger section of
the population at affordable price points.
Priority should also be placed on creating an industry-friendly regulatory
structure which would be aligned with global regulatory regimes which
would enforce market-compliant business practices for the domestic IVD
industry.
The right mix of pro-industry policy initiatives and investment strategies
can position India as a global IVD manufacturing power and leverage its
latent competencies to scale the next level of growth trajectory.

https://www.vccircle.com/medical-devices-sector-needs-incentives-
enhance-innovation/

2016
For example, at present (2016) Indias demand for
IVD (in vitro diagnostics) kits/strips/tubes is largely
met through imports and the quantum of imports is
as high as Rs 2,000 crore and MNCs are the major
suppliers of IVD diagnostics reagents with no
manufacturing presence in India.

http://www.skpgroup.com/data/resource/skp_the_
medical_device_industry_in_india_sep2016_.pdf

The Indian medical device industry is growing at Compounded

Annual Growth Rate (CAGR) of around 15% against the expected
global industry growth of 4-6% and is expected to reach INR 602
billion by 2020. According to a report issued by the HealthCare
Federation of India (NATHEALTH), the Indian medical device industry
would grow faster than the global medical devices industry by 2020.
Sectoral Initiative

Under the Make in India initiative, the government of India

declared medical devices as one of the focus 25 sectors and
cemented its commitment by allowing 100% FDI in the sector
for both green eld and brown eld projects.

A draft amendment, the Drugs and Cosmetics (Amendment) Bill,

2015 had been introduced so that medical devices can be
separated from the ambit of drugs.

To encourage Make in India, it is imperative for the law to facilitate

ease of doing business and ensure the quality and e cacy of
the products manufactured.

Bearing in mind the requirements of the sector and the changes in

the healthcare delivery mechanism in India, the government
withdrew the Bill in a Cabinet meeting in June 20162. The
reason behind the withdrawal of the Bill was that amending the
existing Act would not do justice fully to their objectives.

The MoHFW will frame separate rules for medical devices under
the existing Act and bring out separate legislations for
regulating medical devices, drugs and cosmetics.

The ministry released the draft Medical Device Rules, 2016 on 12

July 20163 and invited feedback from all stakeholders.

The draft Rules comment upon device registration in India, device

de nitions and classi cation, Noti ed Body roles, etc. The draft
rules seem to be in sync with the rules issued by the Global
Harmonization Task Force (GHTF) bringing India on par with the

global standards. For e.g. all devices including in vitro

diagnostics (IVD) will be categorised into four groups:-

low risk - Class A;

low-moderate risk - Class B;

moderate-high risk - Class C;

high risk - Class D

 The rules would apply to all medical devices andIVD devices
currently covered under the countrys Drugs and Cosmetics
Act, 1940, as well as any devices speci ed from time to time by
the central government.

After extensive discussions with all stakeholders,the draft Rules for

regulating medical devices will be noti ed shortly. The
government intends to table these Acts in the winter session of
the parliament and, according to the MoHFW, no new medical
devices would be noti ed till this new Act is passe

The new National Medical Devices (NMD)

policy
. Proposed
. Pricing Policy
The NMD, as stated above, will have an impact on the prices of
all medical devices. It will introduce a separate price control
order speci c to medical devices. In the rst week of March
2016, the DoP formally proposed (to the Health Ministry) to
bring certain Medical Devices under the Drug Price Control
Order5

After a study conducted by Advanced Medical Technology

Association (AvaMed), the central government is considering
bringing certain medical devices like stents under the price
control regime as the reduction in prices by the manufacturers
was not being passed on to the end consumer6.

The DoP issued a proposed draft noti cation to capthe trading

margins on medical devices at 35% in March. To take this step,
the government set up a committee headed by the Joint
Secretary of the DoP which included members from leading
industry bodies, NGOs, NPPA and the Competition Commission
of India. However, this move was not welcomed by the industry
who requested the government to withdraw the noti cation.

The industry is of the view that a holistic approachhas to

be taken in this regard so that the costs canbe controlled
appropriately. The Chairman of the Confederation of Indian
Industries (CII) Medical Technology Division, on behalf of the
industry, mentioned that unpredictability in pricing norms and
 talk of bringing medical devices under the Essential
Commodities Act will hamper foreign direct investment (FDI),
Make-in-India and investments in R&D.

ICMED certi cation

Industry experts have recommended the Centreto make the Indian
Certi cation of Medical Devices (ICMED), the countrys rst
indigenously developed quality assurance system for medical
devices mandatory for all medical devices marketed within the
country.

The certi cation scheme being launched has two certi cation
options, ICMED 9000 certi cation (an International Organization
for Standardization (ISO) 9001 plus additional requirements)
for low-risk medical devices and ICMED 13485 (an ISO 13485
plus additional requirements) for medium and higher risk
devices.

This certi cation is a joint initiative of the Association of Indian

Medical Device Industry (AIMED), Quality Council of India (QCI)
and the National Accreditation Board for Certi cation Bodies
(NABCB). NABCB is an accrediting, certifying and inspecting
body andits accreditation programmes are internationally
equivalent, placing it on par with European and American
accreditation bodies. This equivalence would help the
acceptance of an ICMED certi cation in the international
market8.

AIMED, acting on the long standing demand ofthe industry of an

independent but indigenous certi cation, took the initiative and
collaborated with QCI and NABCB to come up with the certi
cation.

Intertek, a leading Total Quality Assurance provider to industries

worldwide, has been approved as Indias rst certi cation body
for the ICMED scheme.9

AIMED strongly advocated the requirement ofICMED certi cation as

the scheme will be able to ll a regulatory vacuum in the quality
certi cation space for medical devices in the country. This will
also enhance the competitiveness and pro tability of the Indian
medical device industry, increase pateint safety and con dence
amongst the buyers.

Electronics Development Fund (EDF)

 The Ministry of Electronics & Information Technology (MEITY)
launched the Electronics Development Fund (EDF)16 in February
2016 which is a structured initiative as a Fund of Funds to
participate in Daughter Funds which in turn will provide risk
capital to companies developing new technologies in the area
of electronics, nano-electronics and Information Technology
(IT).

The supported Daughter Funds will promote innovation, R&D

and product development within the country in the speci ed
elds of electronics, nano- electronics and IT. This R&D in turn is
expected to reduce the dependence on foreign technology for
our medical devices and the funds can also be used to acquire
a company/technology that might be the future of medical
devices.

Transactions

Kedaara Capital buys 13% in Bengaluru- based

surgical equipment-maker Sutures India
Private equity fund Kedaara Capital bought 13% of CX Partners
stake in the Bengaluru-based surgical equipment-maker
Sutures India for INR 4 billion. The key rationale for the
investment was the companys expansion plans into the
international market and expected healthy growth in
revenue.19

The companys equity value is INR 30 billion. Post- investment, the

majority stake of 52% is held by TPG Growth, followed by 30%
by promoters. CX Partners have retained 7% by selling 13% of
their stake to Kedaara Capital.

Trivitron buys 60% stake in Turkish rm for INR

372.3 million
Medical technology rm Trivitron Healthcare has acquired a 60%
stake in Turkish rm Bome Sanayi Urunleri Dis Tic Ltd Sti. The
remaining 40% stake in IVD device manufacturing rm will be
held by the promoters.

Through this acquisition, Trivitron will acquire Bomes expertise in

running low-cost new born screening programmes in public-
private partnerships.
 Trivitron will now have access to produce IVD kits using Finnish and
Turkish techniques in France, Turkey and India.21 US
medical device-maker Alere Inc. sets up INR
1.5 billion manufacturing facility in India
US-based portable molecular diagnostic products rm Alere Inc. has
set up its rst integrated manufacturing facility in Manesar, near
Delhi. The unit will manufacture over 150 million cartridges
which can be used for rapid tests for infectious diseases
including malaria, dengue and HIV. The facility is spread across
180,000 sq. ft., which will generate 300 new jobs.

With this new world class facility, the company believes that they
would be able to provide affordable rapid diagnostics in India
and throughout the Asia-Paci c region.

The company is also working with state governments and

institutions like the National Aids Control Organisation and
Clinton Foundation.

The new facility is part of the companys Asia-Paci c expansion

plan, as it wants the Indian facility to cater to the growing
demand for rapid diagnostics in the Asia- Paci c region.22

Indian medical device start-ups

It is estimated that India has at least 150 start-ups at several stages

of development with a major focus on ECG and patient monitoring
as point-of-care screening and other diagnostic tools for
haemoglobin, glucose, etc.

Forus Health

Remidio

Sattva Medtech

Pre-screening ophthalmology device

Fundus on Phone and Angio on

Touch diagnostic imaging system retina screening devices

Sattva Medtech

Remidio develops ophthalmic diagnostics technology and has

launched two products i.e. Fundus on Phone and Angio on Touch
diagnostic imaging system. A complete image of the retina requires
a wide- eld imaging camera that costs roughly INR 6.5 million
whereas Remidios Fundus on Phone, priced at INR 180,000, can
connect to a smart phone camera to take pictures of the central part
of the retina. This type

of imaging assists in the early detection of diabetic retinopathy.

Forus Health, Remidio and Sattva Medtech are a few of the start-ups
who have developed revolutionary products which are high-quality
and affordable. Sattva Medtech has developed a small, light and
wearable device to detect fetal distress and notify the doctor

via an SMS in case of emergencies. The price for the device will be
two-thirds the price of similar devices manufactured by Philips and
GE.

High concentration on medical device

segments:
ECGmonitoring
Patientmonitoring
Pointofcarescreeninganddiagnostic tools for
haemoglobin/glucose, etc.

http://www.nishithdesai.com/fileadmin/user_upload/pdfs/Research
%20Papers/The_Indian_Medical_Device_Industry.pdf
The Indian medical device sector is worth approximately USD 5.5
Billion and is growingat 15% CAGR.1 The medical device market is
dominated by imported products, which com- prise of around 75% of
total sales. The domestic companies are largely involved in
manufacturing low-end products for local and as well as inter-
national consumption. Lately, many multina- tional companies have
established local presence by acquiring established domestic
companies or starting a new business.

There are few key factors about operating in India that every serious
player should be aware of. Foreign Direct Investment in medical
device manufacturing sector is now possible without any prior
approval. The Indian legal regime is robust and promotes innovation
and commerce. Being a signatory to the TRIPS Agreement (Trade-
Related Aspects of Intellectual Property Rights), India todays boast
of strong patent, trade mark and copyright protection within its
territory. India has

a competition law regime that ensures a fair playing field to all

interested in Indias domestic market.The Indian Government has
introduced various fiscal measures to promote research,
development, manu- facturing and import of medical devices. There
is no import duty on certain medical equipment. Similarly, a number
of lifesaving medical equipment are exempt from payment of excise
duty. The Indian government has incentivized scientific research and
development by providing weighted deduction.

The regulatory framework in India applicable to medical devices

borrows heavily from the regulatory framework applicable to drugs.
At present, only 15 types of medical devices are regulated
(unfortunately, as drugs). The rest are unregulated. After a lot of
efforts of various stake holders, the government has notified the
Medical Device Rules, 2017, which areto come into effect from the
1st of January, 2018 unless a different date is notified. These rules
will regulate a much larger set of medical devices undera framework
customized for medical devices. This should boost the confidence of
all stakeholders, especially those who have been hesitant to enter
into Indian market because of lack of regulation.

intro

The approximate USD 5.5 Billion worth Indian medical device sector
is Asias fourth largest market, and presents an exciting business
landscape and opportunities for both multi-national and domestic
players
oday, Indias medical device sector is dominated by multi-national
companies, which is evident from the fact thatabout 75% of the
sales are generated by imported medical devices. The domestic
players, on the other hand, were quick to adapt the winds of change
and started to focus on low cost devices. It will come as a surprise to
many that the domestic players in India export more than 60
percent of their output as Indian markets are dominated by such
imported medical devices. Over the years, many multi-nationals
have set up operations in India. However, the natureof majority of
the operations is to only distribute imported devices and provide
support function. Few multi-nationals have started domestic
production too. Some multi-nationals have also entered Indiaby
acquiring domestic manufacturers. For example, in 2008,
Netherland-based Royal Philips Electronics, a leading manufacturer
of General X-Ray acquired Alpha X-Ray Technologies, a leading
manufacturer of cardiovascular X-Ray systems.

The sector is at present growing at around 15% Compound Annual

Growth Rate (CAGR) fora plethora of reasons. A significant
percentage of purchasers of medical devices are private medical
institutions and hospitals. Due to increased competition in Tier I
cities, private enterprises have started to focus on Tier II and Tier III
cities, a market which is until now untapped in India. As private
enterprises expand in lesser explored markets,

the demand for medical devices will expand proportionally. Other

reasons for strong growth prospects of the industry are:

Economic growth leading to higher disposable incomes

Increased Public Spending in Healthcare Increased Penetration of

Health Insurance Improving Medical infrastructure Increasing
affordability due to growing income Increasing number of ailments
Increasing demand due to Medical tourism

The sector is also witnessing strong Foreign Direct Investments

(FDI) inflows, which reflects the confidence of global players in the
Indian market. As per official data, the medical and surgical
equipment sector received a total of INR 8344 Crore (approx. USD
1452 Million) between 2000 and 20162. In 2013 alone, the FDI inflow
was almost INR 920 Crore (approx. USD 138 Million). In 2015, this
number jumped to a new high of INR 1019 Crore (approx. USD 153
Million).3

The major players in Indian market are(in no particular order):

Hindustan Syringes & Medical Devices, Opto Circuits (India), Wipro
GE Healthcare, 3 M, India Medtronic, Johnson& Johnson, Becton
Dickinson, Abbott Vascular, Bausch & Lomb, Baxter, Zimmer India,
Edwards Life Sciences, St. Jude Medical (now a part of Abbott),
Stryker, Baxter, Boston Scientific, BPL Healthcare India, Sushrut
Surgicals, Trivitron Diagnostics, Accurex Biomedical, Biopore
Surgicals, Endomed Technologies, HD Medical Services (India),
Eastern Medikit, Harsoria health care, Nidhi Meditech System, Philips
Medical, Wipro Technologies, HCL Technologies and Texas
Instruments.

Part II

Parameters for classification for in vitro diagnostic medical devices

1.Basic principles for classification of in vitro diagnostic medical

devices:

a. Application of the classification provisions shall be governed by

the intended purpose of the devices.

b. Ift hedeviceisintendedtobeusedin combination with another

device, the classification rules shall apply separately to

each of the devices. Accessories are classified in their own right

separately from the device with which they are used.

c. Software,whichdrivesadeviceorinfluences the use of a device, falls

automatically in the same class.

d. Standalone software, which are not incorporated into the medical

device itself and provide an analysis based on the results from
the analyser, shall be classified in to the same category that of
the in vitro diagnostic medical device where it controls or
 influences the intended output of a separate in vitro diagnostic
medical device.

e. Subject to the clause (c) and (d), software that is not incorporated
in an in vitro diagnostic medical device, shall be classified
usingthe classification provisions as specified in paragraph 2.

f. Calibrators intended to be used with a reagent should be treated in

the same class as the in vitro diagnostic medical device
reagent.

g. If several rules apply to the same device, based on the

performance specified for the device by the manufacturer, the
stringent rules resulting in the higher classification shall apply.

2. Theparametersforclassificationofinvitro diagnostic medical

devices as follows:-

i. Invitrodiagnosticmedicaldevicesfor detecting transmissible agents,

etc.:

a. An in vitro diagnostic medical device shall be assigned to Class D,

if it is intended to be used for detecting the presence of, or exposure
to, a transmissible agent that,-

1.is in any blood, blood component, blood derivative, cell, tissue or

organ, in order to assess the suitability of the blood, blood
component, blood derivative, cell, tissue or organ, as the case may
be, for transfusion or transplantation; or

The Indian Medical Device Industry

Regulatory, Legal and Tax Overview

2. causes a life-threatening disease with a high risk of propagation.

b. An in vitro diagnostic medical device shall be

assignedtoClassC,ifitisintendedforusein,-
Nishith Desai Associates 2017

45

1.

2.

3.
4.

5.

6.

detecting the presence of, or exposure to, a sexually transmitted

agent;

detecting the presence in cerebrospinal fluid or blood of an

infectious agent with a risk of limited propagation (for example,
Cryptococcus neoformans or Neisseria meningitidis);

detecting the presence of an infectious agent, where there is a

significant risk that an erro- neous result will cause death or severe
disa- bility to the individual or foetus being tested (for example, a
diagnostic assay for Chlamydia pneumoniae, Cytomegalovirus or
Methicillin-re- sistant Staphylococcus aureus);

pre-natal screening of women in order to determine their immune

status towards transmissible agents such as immune status tests for
Rubella or Toxoplasmosis;

determining infective disease status or immune status, where there

is a risk that an erroneous result will lead to a patient man- agement
decision resulting in an imminent life-threatening situation for the
patient being tested (for example, Cytomegalovirus, Enter- ovirus or
Herpes simplex virus in transplant patients);

screening for disease stages, for the selection of patients for

selective therapy and management, or in the diagnosis of cancer;

ii. In vitro diagnostic medical devices for self- testing:

a. Subjecttoclause(b),aninvitrodiagnostic medical device shall be

assigned to Class C, if it is intended to be used for self-testing.

b. An in vitro diagnostic medical device referred to in clause (a) shall

be assigned to Class B, if it is intended to be used to obtain,-
1.

2.

test results that are not for the determination of a medically-critical

status; or

preliminary test results which require confirmation by appropriate

laboratory tests.
 human genetic testing, such as the testing for cystic fibrosis or
1.
Huntingtons disease;

2.monitoring levels of medicinal products, substances or biological

components, where there is a risk that an erroneous result will lead
to a patient management decision resultingin an immediate life-
threatening situation for the patient being tested (for example,
cardiac markers, cyclosporin or prothrombin time testing);

3.management of patients suffering from a life-threatening

infectious disease such as viral load of Human immunodeficiency
virus or Hepatitis C virus, or genotyping and sub-typing Hepatitis C
virus or Human immunodeficiency virus);or

4.screening for congenital disorders in the foetus such as Downs

syndrome or spina bifida.

vi. In vitro diagnostic medical devices for blood grouping or tissue

typing:

a. Subjecttoclause(b),aninvitrodiagnosticmedi- cal device shall be

assigned to Class C,if it is intended to be used for blood grouping or
tissue typing to ensure the immunological com- patibility of any
blood, blood component, blood derivative, cell, tissue or organ that
is intended for transfusion or transplantation, as the case may be.

b. An in vitro diagnostic medical device referred to in clause (a) shall

be assigned to Class D, ifit is intended to be used for blood grouping
or tissue typing according to the ABO system, the, the Duffy system,
the Kell system, the Kidd system, the rhesus system (for example,
HLA, Anti-Duffy, Anti-Kidd).

iii. In vitro diagnostic medical devices for near- patient testing:

An in vitro diagnostic medical device shall be assigned to Class C, if

it is to be used for near- patient testing in a blood gas analysis or a
blood glucose determination.

Illustration: Anticoagulant monitoring, diabetes management, and

testing for C-reactive protein and Helicobacter pylori.

iv.In vitro diagnostic medical devices used in in vitro diagnostic

procedures:

An in vitro diagnostic medical device shall be assigned to Class A:

1. if it is a reagent or an article which possesses any specific

characteristic that is intended by
 itsproductownertomakeitsuitableforanin vitro diagnostic
procedure related to a specific examination;
2. an instrument intended specifically to be used for an in vitro
diagnostic procedure; or
3. a specimen receptacle.

v. Other in vitro diagnostic medical devices:

a. An in vitro diagnostic medical device shall be assigned to Class B,

if sub-paragraphs(i) to (v) of paragraph 2 do not apply to it; or

b. Itisasubstanceordeviceusedforthe assessment of the performance

of an analytical procedure or a part thereof, without a quantitative or
qualitative assigned value.

Make an glossary

http://www.raps.org/Regulatory-Focus/News/2017/02/23/26946/Final-
Versions-of-EU-MDR-IVD-Released-Voting-Begins-Next-Month/

https://www.infosys.com/consulting/insights/Documents/indian-
medical-device-industry.pdf

http://data.consilium.europa.eu/doc/document/ST-10729-2016-
INIT/en/pdf

http://www.marketwired.com/press-release/eu-ivd-regulation-top-
five-changes-medical-device-manufacturers-consider-new-webinar-
2215276.htm