Kiwa Supports India’s MedTech Ambitions at GRIT Gandhinagar 2026
Kiwa was proud to participate in the GRIT Gandhinagar 2026 conference, “Gujarat to Global: Empowering the MedTech Ecosystem,” held on 23 June 2026 in Gandhinagar, Gujarat, India. The event brought together policymakers, regulatory experts, industry leaders, and medical device manufacturers to discuss how India’s rapidly growing MedTech sector can strengthen its position in global markets.
As India continues to invest in medical device manufacturing through initiatives such as the Medical Device Parks program and the Production Linked Incentive (PLI) scheme, manufacturers are increasingly focusing on international regulatory compliance, quality management, and export readiness. The conference provided a platform to address these opportunities and challenges while fostering collaboration between industry and government stakeholders.
Representing Kiwa, Dr. Sunil Kale, Operations Head of Kiwa’s EU Notified Body activities, contributed as a speaker during the session “Global Submission Strategy: 510(k), De Novo, PMA, EU MDR & EU IVDR — A Decision Framework.” The session explored global regulatory pathways and helped manufacturers better understand how to navigate the requirements of both European and US markets.
During his presentation, Dr. Sunil Kale provided practical guidance on the European Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). He explained the transition from traditional market approval approaches toward a lifecycle-based compliance framework that emphasizes patient safety, regulatory oversight, and continuous post-market monitoring.
The presentation covered key topics including device classification, the role of Notified Bodies, clinical evaluation requirements, technical documentation, quality management systems according to ISO 13485, and post-market surveillance obligations. Attendees also gained insights into conformity assessment routes, common certification challenges, certification timelines, EUDAMED requirements, and important MDR/IVDR transition deadlines.
A central message from Kiwa’s contribution was that successful access to the European market requires early planning, correct device classification, robust clinical evidence, effective quality management systems, and ongoing post-market surveillance. Manufacturers that adopt these practices early are better positioned to achieve and maintain compliance while building trust in their products internationally.
Kiwa remains committed to supporting medical device manufacturers worldwide through certification, regulatory expertise, and quality assurance services. Events such as GRIT Gandhinagar 2026 demonstrate the growing importance of international collaboration in advancing innovation, patient safety, and global market access for the MedTech industry.
Our services for the Medical Industry
Medical devices are a heterogeneous category of products, such as active equipment, implants, reusable instruments, substances and materials, Sw, and more. All of them intended for use on humans and therefore their safety and performance are of vital importance. To be put on the market and traded in EU, medical devices must comply with pertaining European legislations. As Kiwa we can provide complete and reliable information on the appropriate medical devices certification process to undertake, and deliver qualified conformity assessment activities and related services.
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