From Local to Global: Aligning Indian Medical Manufacturing with International Standards
In an exclusive digital dialogue hosted by mojo4industry titled “From Local to Global: Aligning Indian Medical Manufacturing with International Standards,” industry experts gathered to discuss India’s journey towards becoming a global hub for medical device manufacturing. The event focused on the importance of aligning Indian practices with international standards, ensuring both global competitiveness and enhanced patient safety.
WATCH this explosive episode of Digital Dialogue on: From Local to Global: Aligning Indian Medical Manufacturing with International Standards featuring:
• Dr. Jitendra Sharma, Managing Director & Founder CEO, AMTZ
• Rajiv Nath, Managing Director, Hindustan Syringes & Medical Devices Ltd. & Forum Coordinator, AiMeD
• Manoj K Sundaram, Head – Business Development, Carl Zeiss India
Dr. Jitendra Sharma, Managing Director & Founder CEO of Andhra Pradesh MedTech Zone (AMTZ) – which is the world’s largest medical devices research and manufacturing park. He kicked off the session by emphasizing the critical role of AMTZ in bridging the gap between India’s domestic medical device production and international requirements. He outlined how AMTZ, established in 2018, has evolved into a consolidated space for medical device production, providing infrastructure and services like validation centers, testing labs, and logistics facilities. “AMTZ is a unique cluster that integrates all elements needed for medical technology production, ensuring that Indian-made devices meet both national and international standards,” he stated. Dr. Sharma highlighted three key steps to enhance India’s global standing: the need for mutually accepted certification systems, careful consideration of trade agreements, and building a robust pool of qualified auditors to ensure compliance.
Rajiv Nath, Managing Director of Hindustan Syringes & Medical Devices Ltd. and Forum Coordinator of the Association of Indian Medical Device Industry (AiMeD) – an umbrella association of Indian manufacturers covering all types of medical devices including consumables, disposables, equipment, instruments, implants, electronics and diagnostics with over 400 members nationwide. He shared his perspective on India’s role in the global medical device market. Mr. Nath discussed the evolution of regulatory standards and how India’s certification frameworks, like the Indian Certification for Medical Devices (ICMED) and the Zero Defect, Zero Effect (ZED) certification, are positioning Indian manufacturers to meet global demands. He emphasized that quality standards need to go beyond the minimum regulatory requirements and must be demonstrated through third-party audits to build confidence with international buyers. “To truly compete globally, we need to move from quality control to quality assurance and demonstrate our competence through certifications recognized worldwide,” he added.
Manoj K. Sundaram, Head of Business Development at Carl Zeiss India, offered insights into how quality and metrology play a crucial role in medical device manufacturing. Mr. Manoj pointed out that, as India rapidly emerges as a global player in medical device manufacturing, ensuring top-notch quality is more important than ever. “Our focus must be on precision and reliability at every stage of production,” he said. “Quality cannot be an afterthought—it has to be ingrained in the entire manufacturing process, from the initial stages of design to the final product.”
During the discussion, Mr. Manoj also highlighted the importance of aligning Indian certification systems with international norms. “For India to truly establish itself as a global leader in medical device manufacturing, it is crucial to adopt globally recognized certification systems. This will not only enhance the credibility of Indian-made devices but also open up more export opportunities,” he emphasized.
As the medical device sector in India continues to grow, the need for collaboration between industry and regulatory bodies becomes even more important. Mr. Sundaram added, “There has to be a continuous dialogue between manufacturers, industry associations, and government agencies to ensure that the certification and quality systems in place are robust and aligned with global standards.”
Watch this episode now!
