Navigating Global Regulatory Challenges in Medical Devices: What India Needs to Accelerate Global Expansion

By- Kaustav Banerjee, CEO, Alkem Medtech

Envision an innovative Indian medical device startup developing a groundbreaking product poised to revolutionize global patient care. For high-risk devices with limited global volume or treatments for rare diseases, scaling beyond the domestic market is crucial to fully realize their potential. However, despite their promise, these startups encounter a labyrinth of regulatory challenges that can stifle their growth aspirations and impede expansion into developed markets. This scenario is all too familiar for many Indian medical device companies striving to penetrate developed markets, even when their solutions address global problems.

Diverse and Stringent Regulatory Requirements

Countries have distinct regulatory frameworks, such as the FDA for the US, MDD/MDR for Europe, TGA for Australia, and PMDA for Japan. Complying with multiple regulatory standards demands significant time, cost, and expertise. To help Indian companies tackle global challenges, harmonizing Indian regulations with international standards is crucial. This alignment will aid Indian companies in meeting international regulatory requirements. Additionally, investing in regulatory intelligence and training is essential to stay updated with evolving global regulations. Since building a robust system can be costly for smaller companies, the Indian government can establish a platform to support startups and other Indian companies with global ambitions.

Lack of Harmonization in Regulatory Pathways

Countries like China, Brazil, and Russia have unique approval pathways not aligned with IMDRF standards. Additional country-specific clinical trials add to regulatory burdens. Working towards compliance with IMDRF guidelines can ease entry into multiple markets. Utilizing programs like MDSAP (Medical Device Single Audit Program) can meet multiple regulatory requirements in one audit, making the process more efficient.

Long and Costly Approval Processes

Clinical evaluations, documentation, and compliance testing (e.g., biocompatibility, sterilization validation) are associated with high costs. Early regulatory engagement and pre-submission meetings with agencies like the FDA and notified bodies can mitigate these costs. Evaluating opportunities to leverage predicate devices can shorten approval timelines. Seeking mutual recognition agreements (MRAs) where applicable (e.g., IMDRF member countries) can also help.

Adapting to the EU MDR/IVDR Regulations

The transition from MDD to MDR has made compliance tougher with more stringent clinical data requirements and post-market surveillance. Smaller manufacturers struggle with high costs and longer certification timelines. Developing robust clinical evaluation reports (CERs) and real-world evidence (RWE) is crucial for MDR compliance.

FDA Approval Challenges for US Market Entry

The US FDA requires strong clinical validation, manufacturing controls, and risk-based classification. The De Novo process is costly and time-consuming for novel devices. Adopting ISO 13485, as it aligns with 21 CFR Part 820 (QSR), can facilitate smoother FDA compliance. Using the Breakthrough Devices Program can expedite approvals for innovative technologies. Engaging with the FDA’s pre-submission process provides guidance on approval pathways.

Global Supply Chain and Post-Market Compliance

Countries demand stringent measures for traceability, cybersecurity, and post-market surveillance (PMS) data, with a risk of recalls due to failures in post-market monitoring. To mitigate these challenges, it is essential to implement UDI (Unique Device Identification) systems in accordance with global norms such as those set by the FDA, EU, and India. Strengthening post-market surveillance can be achieved through the adoption of automated reporting tools, enhancing the ability to track and manage device performance effectively. Additionally, leveraging real-world data (RWD) and AI-driven analytics can provide proactive risk management, identifying potential issues before they escalate into significant problems.

Trade Barriers and Tariff Issues

High import duties on raw materials for medical devices in some countries, coupled with non-tariff barriers such as local testing requirements, significantly increase costs. To mitigate these issues, it is essential to leverage free trade agreements (FTAs) and bilateral trade policies to reduce tariffs. Additionally, manufacturing certain components locally in target markets can help comply with localization policies, thereby reducing costs and facilitating smoother market entry.

Local Testing Facilities as per Global Requirements

Aligning with global standards is crucial. India is working towards harmonizing its quality standards with international norms to position itself as a reliable hub for medical devices. This involves regulatory reliance and convergence with other regulators and adherence to international standards such as those proposed by the American Standard Test Method (ASTM).

Adopting Best Practices from Global Markets

Learning from the best practices of developed and emerging markets can accelerate innovation and regulatory compliance. For instance, Singapore’s consultation services and regulatory reviews during the development phase of a medical device can expedite the approval process. Similarly, Thailand’s third-party review system and resubmission allowances for rejected applications can improve the efficiency of the registration process.

Leveraging Innovation-Friendly IP Laws

Simplifying and streamlining intellectual property (IP) processes can significantly reduce the time and costs associated with obtaining and maintaining patents. MedTech startups should proactively understand and utilize these streamlined IP processes to protect their innovations and encourage further development.

Extending the MedTech Mitra Platform

The MedTech Mitra initiative, a collaboration between CDSCO, ICMR, and GeM, is a powerful platform to support Indian innovations and startups in MedTech. Expanding this support to global markets can help Indian startups become billion-dollar enterprises.

Key Areas of Support

- Create a real time repository of regulatory intelligence and extend training to keep up with evolving global regulations.

- Facilitate clinical evaluation of medical devices as required by EU MDR, US FDA, Japanese MDA, and other developed markets, extending financial support/subsidy.

- Establish local testing facilities in MedTech parks meeting ASTM standards, making India self-reliant in testing medical devices. Alternatively, decentralized testing facilities can be implemented in academic institutions like IIT and IISc.

- Provide IP-related consulting support to Indian startups to build robust IP protection for innovations.

Call to Action

Indian MedTech companies stand at the cusp of global opportunities, but success will require collaboration, innovation, and strategic planning. Stakeholders, including government bodies, industry leaders, and startups, must unite to:

- Advocate for regulatory harmonization and streamlined approval processes.

- Invest in regulatory intelligence, training, and infrastructure.

- Foster partnerships to leverage global best practices and technology.

- Support innovative startups with financial subsidies and consulting services.

By taking these proactive steps, India can accelerate the global expansion of its medical device industry, fostering innovation and growth while ensuring compliance with international standards. Let's work together to unlock the full potential of Indian MedTech on the global stage.

Final Thoughts

Indian medical device companies need proactive regulatory strategies, global compliance frameworks, and strong partnerships to overcome these barriers. Investing in digital health technologies, regulatory automation, and real-world evidence collection will further enhance global competitiveness.