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Standardization and Legislation of Medical equipment

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Title: Standardization and Legislation of Medical equipment Author: Helenka Anand Last modified by: Helenka Anand Created Date: 4/30/2008 7:50:03 AM – PowerPoint PPT presentation

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Title: Standardization and Legislation of Medical equipment


1
Standardization and Legislation of Medical
equipment
  • Dr. Sunil Anand
  • MD Medicine
  • Diploma Anesthesia ( UK )
  • Medical Consultant

2
Standardization and Legislation of Medical
equipment
3
Standardization and Legislation of Medical
equipment
4
Standardization and Legislation of Medical
equipment
  • There is, at present no standardization or
    effective legislation for Medical equipment

5
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

6
The need
  • 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.

7
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

8
The Need
  • India is a very price conscious market and
    attempts are always made to reduce costs
  • Unscrupulous manufacturers/importers move
    equipments into India which are not safe
  • Machines are used inappropriately and without
    proper maintenance , calibration etc .

9
The Move Forward
  • Internationally there is an initiative to
    harmonise the medical device regulatory scene
  • Global Harmonisation Task Force ( GHTF )
  • 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.

10
The need
  • It is essential for India to have its own
    regulatory system
  • 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

11
The need
  • 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

12
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

13
The Drug and Cosmetic Act
  • Has relevant standardization and legislation in
    place
  • Does not cover equipments
  • Is well regulated
  • Good infrastructure for implementation

14
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 )

15
Standardization and Legislation of Medical
equipment
  • In the healthcare sector there are many
    stakeholders
  • Doctors
  • Manufacturing Industry
  • Hospital facility providers
  • Insurance companies

16
Standardization and Legislation of Medical
equipment
17
Standardization and Legislation of Medical
equipment
  • At present regulation is either self regulated by
    manufacturers
  • Or indirectly regulated Xray equipment
  • No Act or legislation to monitor and regulate it

18
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.

19
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

20
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

21
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

22
IMRDAThe 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

23
IMRDAEssential 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

24
IMRDAObjectives
  • 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

25
IMRDAThe 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

26
IMRDAClassification
  • 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
  • Regulations will be proportionate to Class

27
Standardization and Legislation of Medical
equipment
  • Regulations and cost of healthcare are directly
    proportionate
  • 1000 India
  • 4000 Europe
  • 7000 Europe
  • 12,000 Japan
  • No marks for guessing which is the most regulated
    market in the world !

28
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 .

29
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 .

30
Standardization and Legislation of Medical
equipment
31
Standardization and Legislation of Medical
equipment
32
Standardization and Legislation of Medical
equipment
  • Thank you
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