Noida's Medical Device Park to Feature USFDA-ASCA Certified Testing Facilities
The Yamuna Expressway Industrial Development Authority has forged a strategic partnership with Ahmedabad-based Accuprec Research Labs to establish ASCA-certified testing laboratories at the upcoming medical device park in Sector 28. This collaboration marks a significant advancement in India's medical technology infrastructure, aiming to create a globally recognized testing ecosystem.
Understanding the ASCA Program and Its Global Implications
The ASCA (Accreditation Scheme for Conformity Assessment) program, administered by the United States Food and Drug Administration (USFDA), authorizes testing laboratories to conduct conformity assessments for medical devices according to specified international standards. This initiative, which was discussed at the WHX Dubai summit, seeks to develop testing infrastructure that aligns with USFDA-recognized standards, thereby facilitating smoother international market access for Indian medical device manufacturers.
Collaborative Efforts and Technical Assessments
The partnership commenced with an initial meeting between Dr. Manish Rachchh, Director of Accuprec Research Labs, and a delegation from the Yamuna Expressway Authority. Following this, a comprehensive technical team from Accuprec conducted an on-site visit to evaluate the existing infrastructure and facilities at the medical device park location.
The site inspection was led by Shailendra Kumar Bhatia, Additional Chief Executive Officer of the Authority, alongside Praveen Kumar Mittal, Executive Director of the Export Promotion Council, and officials from the project department. During the visit, consultants from Ernst & Young delivered a detailed presentation outlining the planned common scientific facilities and the proposed equipment installations for the medical devices park.
The technical team meticulously examined the integration of laboratory requirements with utilities and engineering systems, ensuring that the facilities would meet stringent regulatory standards.
Investment Structure and Strategic Benefits
Accuprec Research Labs has proposed a two-phase investment structure for this ambitious project:
- Phase One: Upgrading and operating the existing common scientific facilities to comply with ASCA requirements and other regulatory standards.
- Phase Two: Developing additional testing modules to cover medical device segments not currently addressed by the existing infrastructure.
According to officials, the establishment of ASCA-certified testing facilities within the park will provide manufacturers operating in the zone with the unprecedented advantage of conducting product testing at the same location. This integration is expected to significantly reduce time-to-market and enhance competitiveness in the global medical device industry.
Timeline and Next Steps
Authorities have established a strict timeline of one month for Accuprec Research Labs to submit a comprehensive technical feasibility report. This document will detail the implementation strategy, technical specifications, and regulatory compliance measures necessary for establishing the ASCA-certified laboratories.
This development represents a crucial step forward in positioning Noida's medical device park as a hub for world-class medical technology manufacturing and testing, potentially attracting significant domestic and international investment in the healthcare sector.
