Noida: Yamuna Expressway Industrial Development Authority has partnered withAhmedabad-based Accuprec Research Labs to set up ASCA-certified testing laboratories at the medical device park coming up in Sector 28.The ASCA programme of the United States Food and Drug Administration (USFDA) allows testing laboratories to conduct conformity assessments for medical devices under specified standards. The plan, discussed at the WHX Dubai summit, aims to build a globally accepted testing infrastructure aligned with USFDA-recognised standards An initial meeting was held between the director of Accuprec, Dr Manish Rachchh and a delegation of the Authority. Subsequently, a technical team from Accuprec visited the area to review infrastructure and facilities.The visit was led by the additional chief executive officer of the Authority, Shailendra Kumar Bhatia, along with the executive director of the Export Promotion Council, Praveen Kumar Mittal and officials from the project department. Consultants from Ernst & Young gave a presentation on the common scientific facilities planned at the medical devices park and the equipment proposed to be installed. The team also conducted a site inspection of the facilities to examine the integration of laboratory requirements with utilities and engineering systems.According to officials, Accuprec has proposed a two-part investment structure. The first involves upgrading and operating the existing common scientific facilities to align with ASCA requirements and other regulatory standards. The second entails the development of additional testing modules for segments not covered under the current infrastructure.Bhatia said the inclusion of ASCA-certified testing facilities within the park would enable manufacturers operating in the zone to undertake product testing at the same location. Officials have set a timeline of one month for submission of a technical feasibility report by Accuprec.
