Kiwa Launches Kiwa India Medical to Provide Medical Device Certification Services
Kiwa has launched Kiwa India Medical, a specialized business entity aimed at offering medical device certification and regulatory assurance services across India. Operating through KGI Certification Pvt. Ltd., a Kiwa Group company, the new business combines international medical device certification networks with local operational expertise. The initiative is designed to assist Indian manufacturers in demonstrating compliance with relevant regulatory criteria, improving quality management, and expanding into international healthcare markets.
What Happened
Kiwa announced the establishment of Kiwa India Medical to address the growing operational and regulatory requirements of the Indian medical technology sector. The business operates via KGI Certification Pvt. Ltd. and offers independent certification alongside conformity assessment services for medical devices and quality management systems.
According to the company, manufacturers in the medical device sector frequently encounter operational hurdles such as extended certification timelines, rapidly shifting regulatory requirements, and restricted visibility during assessment processes. Kiwa India Medical aims to resolve these issues by delivering clear communication, structured evaluation steps, predictable timelines, and technical assessment services to support manufacturers in gaining global market access.
Key Highlights
- Corporate Entity: Kiwa India Medical operates through KGI Certification Pvt. Ltd., which is part of the Kiwa Group.
- Core Services: The business delivers independent certification and conformity assessment services for medical devices and quality management systems.
- Leadership Expertise: The leadership team includes Joher Jerwalla as Head of Medical Device Business, Vishal Bhat as Head of Business Development, and Dr. Sunil Kale as Head of Operations.
- Strategic Objectives: The venture focuses on tackling key industry challenges, including prolonged certification cycles, limited visibility into assessment progress, and changing regulatory standards.
- Market Focus: The entity combines Kiwa’s global regulatory and technical network with local knowledge to assist Indian manufacturers in reaching global markets.
Why This Matters
India’s medical device industry is expanding rapidly, driving increased demand for competent and predictable certification partners. Access to global markets requires compliance with strict international regulatory and quality standards, making transparent conformity assessment vital for domestic manufacturers.
Commenting on the expansion, Ad Besemer, Executive Vice President at Kiwa, stated that the launch marks an important milestone in the company’s global growth strategy and reinforces its commitment to India’s healthcare market. Besemer highlighted India’s key role in the future of medical device innovation and manufacturing, noting that the investment will help organizations reach quality, compliance, and market access objectives.
Joher Jerwalla, Head of Medical Device Business, emphasized that the medical device sector requires certification partners that blend technical competence with responsiveness and customer focus. Jerwalla noted that the organization is dedicated to maintaining high standards of quality, integrity, and patient safety while providing clear communication and predictable processes.
What to Watch Next
Following the launch, Kiwa India Medical intends to establish long-term partnerships with Indian medical device manufacturers. The leadership team—comprising experienced professionals in certification, testing, clinical practice, and device development—will lead operational efforts to streamline certification pathways and help Indian medical technology firms meet global regulatory expectations.
Frequently Asked Questions
What is Kiwa India Medical?
Kiwa India Medical is a business entity launched by Kiwa, operating through KGI Certification Pvt. Ltd., dedicated to delivering medical device certification and regulatory assurance services in India.
Who leads Kiwa India Medical?
The leadership team includes Joher Jerwalla (Head of Medical Device Business), who has over forty years of professional experience including over thirty years in certification; Vishal Bhat (Head of Business Development), who brings thirty years of experience in testing, inspection, and certification; and Dr. Sunil Kale (Head of Operations), a medical doctor with a Master’s degree from IIT Kharagpur and sixteen years of clinical and device development experience.
What specific services does Kiwa India Medical offer?
The company provides independent certification and conformity assessment services for both medical devices and quality management systems to help manufacturers comply with applicable regulatory requirements.
Source: Based on reporting by Medical Buyer.