standardization and legislation of medical equipment dr. sunil anand md medicine diploma anesthesia...

Standardization and Legislation of Medical Standardization and Legislation of Medical equipmentequipment

Dr. Sunil Anand Dr. Sunil Anand

MD MedicineMD Medicine

Diploma Anesthesia ( UK ) Diploma Anesthesia ( UK )

Medical ConsultantMedical Consultant

Standardization and Legislation of Standardization and Legislation of Medical equipmentMedical equipment


There is, at present no standardization or There is, at present no standardization or effective legislation for Medical equipmenteffective legislation for Medical equipment

The needThe need

Total number of medical devices Total number of medical devices estimated to be 1.5 million different kindsestimated to be 1.5 million different kinds

Value of goods worldwide 260 BILLION Value of goods worldwide 260 BILLION dollarsdollars

Indian market 1.5-2 billion dollarsIndian market 1.5-2 billion dollars80% of the Indian needs met by imports80% of the Indian needs met by importsLocal industry not present in high tech Local industry not present in high tech

devices devices

The need The need

Indian medical equipment industry today is Indian medical equipment industry today is 1.5 Billion US Dollars1.5 Billion US Dollars

Slated to increase by 15-20% per yearSlated to increase by 15-20% per yearWill be 5 Billion US Dollar by the year 2012Will be 5 Billion US Dollar by the year 2012Healthcare facilities are increasing too and will Healthcare facilities are increasing too and will

treating a larger number of patients who need to treating a larger number of patients who need to be protected.be protected.

The needThe need

Today electro medical equipment can be Today electro medical equipment can be imported without any permission, license imported without any permission, license or any restrictionor any restriction

There is no check whether the product has There is no check whether the product has any approvals even in the country of their any approvals even in the country of their origin.origin.

Can be sold freely to any healthcare Can be sold freely to any healthcare facility in Indiafacility in India

The Need The Need

India is a very price conscious market and India is a very price conscious market and attempts are always made to reduce costsattempts are always made to reduce costs

Unscrupulous manufacturers/importers move Unscrupulous manufacturers/importers move equipments into India which are not safe equipments into India which are not safe

Machines are used inappropriately and without Machines are used inappropriately and without proper maintenance , calibration etc .proper maintenance , calibration etc .

The Move ForwardThe Move Forward Internationally there is an initiative to harmonise the Internationally there is an initiative to harmonise the

medical device regulatory scenemedical device regulatory scene

GGlobal lobal HHarmonisation armonisation TTask ask FForce ( GHTF ) orce ( GHTF ) USA, USA, Japan,Japan, Canada, Canada, Australia Australia The EUThe EU Brazil,South Korea,and China – observersBrazil,South Korea,and China – observers

AAsian sian HHarmonisation armonisation WWorking orking PParty ( AHWP ) arty ( AHWP )

The AHWP works with the GHTF to forge a common The AHWP works with the GHTF to forge a common direction for harmonisation in Asia Pacific. direction for harmonisation in Asia Pacific.

The need The need

It is essential for India to have it’s own It is essential for India to have it’s own regulatory system regulatory system

Protect the Indian consumer.Protect the Indian consumer. Prevent India becoming a dumping ground for obsolete Prevent India becoming a dumping ground for obsolete

and poor quality medical productsand poor quality medical products Protect the domestic manufacturerProtect the domestic manufacturer Indians to have a say in world market Indians to have a say in world market

The need The need

India needs to be part of these forums , India needs to be part of these forums , failing which we will be disadvantagedfailing which we will be disadvantaged

At WTO negotiationsAt WTO negotiationsWill not understand fully the benefits of these Will not understand fully the benefits of these

forumsforumsWorse, will not be aware of the drawbacks of the Worse, will not be aware of the drawbacks of the

harmonization in years to comeharmonization in years to come

The Drug and Cosmetic ActThe Drug and Cosmetic Act

Has been in existence for a long time.Has been in existence for a long time.Covers the pharmaceutical and cosmetic Covers the pharmaceutical and cosmetic

productsproductsAdded medical devices as early as 1992 Added medical devices as early as 1992

( Syringes , needles etc)( Syringes , needles etc)10 items added in 2006 eg. Heart valves, 10 items added in 2006 eg. Heart valves,

catheters etc. the import of which is now catheters etc. the import of which is now through registrationthrough registration

The Drug and Cosmetic ActThe Drug and Cosmetic Act

Has relevant standardization and Has relevant standardization and legislation in placelegislation in place

Does not cover equipmentsDoes not cover equipments Is well regulatedIs well regulatedGood infrastructure for implementationGood infrastructure for implementation

International ScenarioInternational Scenario

No standardization of medical equipment No standardization of medical equipment nor any effective legislation in place in nor any effective legislation in place in IndiaIndia

Effective but very bureaucratic in USA Effective but very bureaucratic in USA Effective and less bureaucratic in the EUEffective and less bureaucratic in the EUPresent in Japan, Taiwan Korea, Australia Present in Japan, Taiwan Korea, Australia

etc.etc.All primarily for protection of their domestic All primarily for protection of their domestic

sector (e.g USA FDA )sector (e.g USA FDA )


In the healthcare sector there are many In the healthcare sector there are many stakeholdersstakeholders

DoctorsDoctors

Manufacturing IndustryManufacturing Industry

Hospital facility providersHospital facility providers

Insurance companiesInsurance companies


At present regulation is either self At present regulation is either self regulated by manufacturers regulated by manufacturers

Or indirectly regulated – Xray equipmentOr indirectly regulated – Xray equipment

No Act or legislation to monitor and No Act or legislation to monitor and regulate itregulate it


As no regulatory framework leads even As no regulatory framework leads even the Drug Controller General of India has the Drug Controller General of India has no mandate on regulation. He refers the no mandate on regulation. He refers the issues to ‘others’.issues to ‘others’.

Thermometer go to BIS Thermometer go to BIS The Indian manufacturer faces a tough The Indian manufacturer faces a tough

uphill task to import items that are not uphill task to import items that are not certified by a regulatory authority and is certified by a regulatory authority and is forced to get an international certification.forced to get an international certification.


Many committees had been set up and Many committees had been set up and given their opinion and recommendation , given their opinion and recommendation , like the Mahelkar Committee – Central like the Mahelkar Committee – Central Drug Standard Control OrganisationDrug Standard Control Organisation

ICMR & SBMT– IMDRAICMR & SBMT– IMDRAFICCI - MEFFICCI - MEF

All these are now being taken into to form All these are now being taken into to form the Indian Medical Device regulatory Actthe Indian Medical Device regulatory Act


What is the IMRDA ?What is the IMRDA ?

Indian Medical Devices Regulatory Act Indian Medical Devices Regulatory Act come in force December 31, 2009 come in force December 31, 2009

Inputs to be sent to Dr. B Hari Gopal , Inputs to be sent to Dr. B Hari Gopal , Adviser Department of Science and Adviser Department of Science and Technology, New Delhi Technology, New Delhi

IMRDAIMRDA

The composition of the committee is by The composition of the committee is by representation of representation of

Central GovernmentCentral GovernmentEminent JuristEminent JuristTwo eminent medical practitionersTwo eminent medical practitionersTwo eminent medical technologistsTwo eminent medical technologistsSecretary General Quality councilSecretary General Quality councilCEO MRDACEO MRDA

IMRDAIMRDAThe essential elements The essential elements

Absolute safety can not be guaranteedAbsolute safety can not be guaranteed It is a risk management issueIt is a risk management issue It is closely aligned with device It is closely aligned with device

effectivenesseffectivenessMust be considered throughout the life Must be considered throughout the life

span of the devicespan of the deviceRequires shared responsibility of Requires shared responsibility of

stakeholdersstakeholders

IMRDAIMRDAEssential principlesEssential principles

Should not compromise health and safety Should not compromise health and safety Design and manufacture of devices must Design and manufacture of devices must

conform with safety principlesconform with safety principlesLong term safety should be ensuredLong term safety should be ensuredBenefits of the devices must outweigh any Benefits of the devices must outweigh any

side effectsside effectsMedical devices should be useful for the Medical devices should be useful for the

intended purposeintended purpose

IMRDAIMRDAObjectivesObjectives

Provide notification of essential principlesProvide notification of essential principlesProvide for risk based classification of Provide for risk based classification of

devicesdevicesNotify standards and guidelines Notify standards and guidelines Provide mechanism of conformityProvide mechanism of conformityProvide a post market surveillance systemProvide a post market surveillance systemProvide for enforcementProvide for enforcement

IMRDAIMRDAThe regulationThe regulation

Will issue Will issue Principles of safetyPrinciples of safetyDesign and manufacturing requirementsDesign and manufacturing requirementsPerformance evaluationPerformance evaluationDemonstration of device standards , testing and Demonstration of device standards , testing and

compliancecomplianceRegulation of post marketing follow upRegulation of post marketing follow upRegulation of recallsRegulation of recallsLegislate and punishment for non complianceLegislate and punishment for non compliance

IMRDAIMRDAClassificationClassification

Class A– Devices involving low risk levelsClass A– Devices involving low risk levelsClass B– devices involving low to medium Class B– devices involving low to medium

riskriskClass C – Devices involving moderate to Class C – Devices involving moderate to

high riskhigh riskClass D– Devices involving high riskClass D– Devices involving high risk

Regulations will be proportionate to ClassRegulations will be proportionate to Class


Regulations and cost of healthcare are Regulations and cost of healthcare are directly proportionatedirectly proportionate

$ 1000 India$ 1000 India$ 4000 Europe$ 4000 Europe$ 7000 Europe$ 7000 Europe$ 12,000 Japan $ 12,000 Japan

No marks for guessing which is the most No marks for guessing which is the most regulated market in the world !regulated market in the world !

Way forwardWay forward

All stake holders have a role to playAll stake holders have a role to playThe IMRDA is an excellent way forwardThe IMRDA is an excellent way forwardALL Imports should be regulatedALL Imports should be regulatedFDA or CE marked goods should be fast FDA or CE marked goods should be fast

tracked for registrationtracked for registration We should not reinvent the wheel – but We should not reinvent the wheel – but

put in place a regulatory mechanisms put in place a regulatory mechanisms based on established regulations .based on established regulations .


We need not reinvent We need not reinvent the wheel the wheel

We need to find a We need to find a balance of the various balance of the various other regulatory other regulatory mechanisms to make mechanisms to make one for us .one for us .


Thank you Thank you

standardization and legislation of medical equipment dr. sunil anand md medicine diploma anesthesia...

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