Standardization and Legislation of Medical equipment

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

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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 it’s 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

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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 .

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32. Standardization and Legislation of Medical equipment Thank you