Transcript Standardization and Legislation of Medical equipment

Standardization and Legislation of Medical
equipment
Dr. Sunil Anand
MD Medicine
Diploma Anesthesia ( UK )
Medical Consultant
Standardization and Legislation of
Medical equipment
Standardization and Legislation of
Medical equipment
Standardization and Legislation of
Medical equipment
There is, at present no standardization or
effective legislation for Medical equipment
The need
Total number of medical devices estimated
to be 1.5 million different kinds
 Value of goods worldwide 260 BILLION
dollars
 Indian market 1.5-2 billion dollars
 80% of the Indian needs met by imports
 Local industry not present in high tech
devices
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The need
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Indian medical equipment industry today is
1.5 Billion US Dollars
 Slated
to increase by 15-20% per year
 Will be 5 Billion US Dollar by the year 2012
 Healthcare facilities are increasing too and will
treating a larger number of patients who need to
be protected.
The need
Today electro medical equipment can be
imported without any permission, license
or any restriction
 There is no check whether the product has
any approvals even in the country of their
origin.
 Can be sold freely to any healthcare
facility in India
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The Need

India is a very price conscious market and
attempts are always made to reduce costs
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Unscrupulous manufacturers/importers move
equipments into India which are not safe
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Machines are used inappropriately and without
proper maintenance , calibration etc .
The Move Forward
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Internationally there is an initiative to harmonise the
medical device regulatory scene
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Global Harmonisation Task Force ( GHTF )
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USA,
Japan,
Canada,
Australia
The EU
Brazil,South Korea,and China – observers
Asian Harmonisation Working Party ( AHWP )
The AHWP works with the GHTF to forge a common
direction for harmonisation in Asia Pacific.
The need
It is essential for India to have it’s own
regulatory system
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Protect the Indian consumer.
Prevent India becoming a dumping ground for obsolete
and poor quality medical products
Protect the domestic manufacturer
Indians to have a say in world market
The need
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India needs to be part of these forums ,
failing which we will be disadvantaged
 At
WTO negotiations
 Will not understand fully the benefits of these
forums
 Worse, will not be aware of the drawbacks of the
harmonization in years to come
The Drug and Cosmetic Act
Has been in existence for a long time.
 Covers the pharmaceutical and cosmetic
products
 Added medical devices as early as 1992 (
Syringes , needles etc)
 10 items added in 2006 eg. Heart valves,
catheters etc. the import of which is now
through registration
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The Drug and Cosmetic Act
Has relevant standardization and
legislation in place
 Does not cover equipments
 Is well regulated
 Good infrastructure for implementation
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International Scenario
No standardization of medical equipment
nor any effective legislation in place in
India
 Effective but very bureaucratic in USA
 Effective and less bureaucratic in the EU
 Present in Japan, Taiwan Korea, Australia
etc.
 All primarily for protection of their domestic
sector (e.g USA FDA )
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Standardization and Legislation of
Medical equipment
In the healthcare sector there are many
stakeholders
Doctors
Manufacturing Industry
Hospital facility providers
Insurance companies
Standardization and Legislation of
Medical equipment
Standardization and Legislation of
Medical equipment
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At present regulation is either self
regulated by manufacturers
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Or indirectly regulated – Xray equipment
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No Act or legislation to monitor and
regulate it
Standardization and Legislation of
Medical equipment
As no regulatory framework leads even
the Drug Controller General of India has
no mandate on regulation. He refers the
issues to ‘others’.
 Thermometer go to BIS
 The Indian manufacturer faces a tough
uphill task to import items that are not
certified by a regulatory authority and is
forced to get an international certification.
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Standardization and Legislation of
Medical equipment
Many committees had been set up and
given their opinion and recommendation ,
like the Mahelkar Committee – Central
Drug Standard Control Organisation
 ICMR & SBMT– IMDRA
 FICCI - MEF
All these are now being taken into to form
the Indian Medical Device regulatory Act
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Standardization and Legislation of
Medical equipment
What is the IMRDA ?
Indian Medical Devices Regulatory Act come
in force December 31, 2009
Inputs to be sent to Dr. B Hari Gopal ,
Adviser Department of Science and
Technology, New Delhi
IMRDA
The composition of the committee is by
representation of
Central Government
Eminent Jurist
Two eminent medical practitioners
Two eminent medical technologists
Secretary General Quality council
CEO MRDA
IMRDA
The essential elements
Absolute safety can not be guaranteed
 It is a risk management issue
 It is closely aligned with device
effectiveness
 Must be considered throughout the life
span of the device
 Requires shared responsibility of
stakeholders
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IMRDA
Essential principles
Should not compromise health and safety
 Design and manufacture of devices must
conform with safety principles
 Long term safety should be ensured
 Benefits of the devices must outweigh any
side effects
 Medical devices should be useful for the
intended purpose
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IMRDA
Objectives
Provide notification of essential principles
 Provide for risk based classification of
devices
 Notify standards and guidelines
 Provide mechanism of conformity
 Provide a post market surveillance system
 Provide for enforcement
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IMRDA
The regulation
Will issue
 Principles
of safety
 Design and manufacturing requirements
 Performance evaluation
 Demonstration of device standards , testing and
compliance
 Regulation of post marketing follow up
 Regulation of recalls
 Legislate and punishment for non compliance
IMRDA
Classification
Class A– Devices involving low risk levels
 Class B– devices involving low to medium
risk
 Class C – Devices involving moderate to
high risk
 Class D– Devices involving high risk
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Regulations will be proportionate to Class
Standardization and Legislation of
Medical equipment
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Regulations and cost of healthcare are
directly proportionate
$
1000 India
 $ 4000 Europe
 $ 7000 Europe
 $ 12,000 Japan
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No marks for guessing which is the most
regulated market in the world !
Way forward
All stake holders have a role to play
 The IMRDA is an excellent way forward
 ALL Imports should be regulated
 FDA or CE marked goods should be fast
tracked for registration
 We should not reinvent the wheel – but
put in place a regulatory mechanisms
based on established regulations .
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Standardization and Legislation of
Medical equipment
We need not reinvent
the wheel
We need to find a
balance of the various
other regulatory
mechanisms to make
one for us .
Standardization and Legislation of
Medical equipment
Standardization and Legislation of
Medical equipment
Standardization and Legislation of
Medical equipment
Thank you