The Rising Cost of Regulatory Compliance. Indian MedTech Industry Seeks Government Intervention
The Indian MedTech industry is experiencing rapid growth, fuelled by innovation, technological advancements, and increased demand for high-quality medical devices. However, this growth comes with significant challenges, particularly the rising cost of regulatory compliance required to meet international standards such as the USFDA, EU MDR/IVDR, and UKCA Marking.
In response to the challenges faced by the Indian medical device industry, the Medical Device Manufacturers Association has recently urged the Government to provide subsidies and financial assistance to support innovation and regulatory approvals/certifications such as CE marking and FDA 510k clearance. This appeal underscores the industry's need for governmental support to enhance global competitiveness and reduce the financial burden associated with the compliance and certification process.
Why Government Support is Needed
While India aspires to become a global MedTech hub, manufacturers face significant barriers that hinder their growth and global competitiveness. The high cost of compliance makes it difficult for startups and smaller companies to comply with international standards. Additionally, the complex documentation, clinical investigation and safety test requirements demand outsourcing and additional costs. The lack of subsidies or incentives further adds to the financial burden, leaving Indian manufacturers at a competitive disadvantage compared to their global counterparts.
Regulatory Expert Opinion
Soio George, a USFDA and EU CE Marking expert from I3CGLOBAL, has supported hundreds of domestic and international companies in achieving regulatory compliance and responded to media asks about the Indian MedTech industry's need for government support.
Q: Why is government support crucial for the Indian MedTech industry?
As an expert in the medical device regulatory field, I have witnessed the complexities and financial challenges that manufacturers face in achieving regulatory compliance. The costs associated with medical device CE marking, and FDA approvals are overwhelming, especially for startups and SMEs.
Support by government subsidies, and skilled development programs can play a transformative role in helping manufacturers meet international standards and access global markets.
Additionally, the government should approve the establishment of high-end laboratories specifically for biocompatibility and electrical safety testing. These specialized testing facilities are crucial for ensuring the safety and efficacy of medical devices, especially as the industry moves towards more advanced and complex technologies. By investing in state-of-the-art laboratories, India can reduce its reliance on foreign testing centres, which are often costly and time-consuming, ultimately streamlining the certification process for manufacturers.
Furthermore, medical devices, particularly life-saving innovations, should be exempted from Goods and Services Tax (GST) for their testing and certification process. This exemption would significantly ease the financial burden on manufacturers, especially those developing cutting-edge technologies. It would also encourage innovation by making it more affordable for companies to bring life-saving devices to market. By supporting these initiatives, the government can foster a more robust and competitive MedTech ecosystem, positioning India as a global leader in the field.
With India’s MedTech sector poised for significant global growth, proactive government intervention is crucial in positioning the country as a leading manufacturing hub. As the world increasingly turns to the China Plus One strategy—seeking alternative manufacturing sources to mitigate reliance on China—India has a unique opportunity to capitalize on this shift. By providing strategic support, such as subsidies for innovation, the establishment of high-end testing laboratories, and a simplified regulatory framework, the government can create an environment that attracts global investors and manufacturers.
Furthermore, India's noticeable software medical device sector is playing a pivotal role in this transformation. As a leader in software development, India is uniquely positioned to drive innovations in Software as a Medical Device (SaMD), which is revolutionizing healthcare by enabling more personalized, data-driven treatment options. Government support for this sector—through regulatory clarity and incentives—will encourage further advancements and allow Indian companies to compete in this rapidly growing market.
Q: What role does I3CGLOBAL play in helping manufacturers overcome challenges?
At I3CGLOBAL, we bring decades of regulatory expertise and have successfully assisted over 1,600 medical device companies with USFDA, EU, and ISO 13485 certifications.
We not only guide manufacturers through technical documentation, risk analysis, substantial equivalence determination and clinical evaluations but also serve as a US Agent, EU Representative and UKRP service to ensure seamless compliance with US, UK and EU regulatory authorities.
Our customer-centric approach, combined with dedicated US, European and UK offices, allows us to provide end-to-end regulatory solutions—helping companies reduce compliance risks, accelerate approvals, and enter global markets confidently.
Conclusion
Fostering innovation, ensuring quality, and maintaining regulatory compliance will be the key to India’s success in becoming the preferred destination for medical device manufacturing. With a focus on advanced technologies and life-saving innovations, India can become a global leader in MedTech, meeting the growing demand for high-quality products in highly regulated markets.
The government intervention will enable manufacturers to overcome financial barriers, streamline the US FDA and EU certification process, and ultimately accelerate their entry into the global market. By positioning India as a competitive alternative to China, the government can support the development of a thriving MedTech ecosystem that drives both economic growth and innovation in the healthcare sector.
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