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India Considering New Device Regulations

Standards and Road Blocks

India will move toward the use of international standard ISO 13485: 2012 quality management systems for medical devices, published by the Bureau of Indian Standards (BIS) as Indian national standard IS 15579: 2005. (Note: BIS has reportedly stated to industry that these standards are identical except for a national foreword and minor editorial changes, e.g., punctuation). Unlike Europe or Global Harmonization Task Force guidance, however, compliance with IS 15579 may be made mandatory. Additionally, a list of EU-harmonized product and process standards and list of BIS standards were exchanged, and industry will provide comments suggesting which out of these should be considered relevant. That being said, Officials in the CDSCO have expressed concerns that ISO 13485 may be insufficiently specific for manufacturers or for external auditors. Industry has sought to explain that this approach is necessary to accommodate the diversity in medical devices, technologies and processes and that more detailed specific guidance is impractical. GHTF guidance documents may be used to supplement the standard.

Like the U.S. and EU systems, quality assurance, risk management and quality management systems will be the responsibility of the manufacturer, who must obtain certification from a notified body for medium and higher risk class devices. The Notified Bodies would also conduct periodic surveillance audits of the manufacturer’s facilities and systems. As I said, the cost of such certification and surveillance will be borne by manufacturers. At this time, however, many in the government feel that India is not fully ready for such a system because it would be viewed as cost-prohibitive by many smaller Indian manufacturers—another mixed message.

Conclusion

The production of low-value medical supplies and disposables is dominated by Indian manufacturers, whereas the highly-critical medical devices are generally imported. In the future, due to the huge market opportunity in India, more and more foreign medical device companies are expected to explore the Indian market for their products.

With an evolving regulatory situation, medical device companies are required to stay up-to-date in order to achieve success in India. The Indian government is working on a comprehensive regulatory framework for the medical device sector. India’s health authorities plan to issue a set of guidelines to define and regulate medical devices as a separate category.

Continued flow of investment dollars by foreign firms has resulted in a steady increase in the market for medical equipment and supplies. The market will continue to grow beyond the boundaries of expectation. It is predicted that India will be the most populous country in the world by 2050, and will make its mark as a growing market, potential partner in manufacturing and Research/Development and as a preferred destination for clinical studies.

 

John Gagliardi has had success over the past 43 years in the Medical Device and Pharmaceutical industries because of his practical approach to process-orientation and business. He has been actively involved in research and development, quality assurance, training, operations, process architecture, FDA inspections and regulatory affairs. John specializes in building systems in a compliant and business-ready manner. John can be reached at This email address is being protected from spambots. You need JavaScript enabled to view it..

MidWest Process Innovation, LLC
www.midwestprocessinnovation.com

 

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