ASCA Lab at UP Medical Devices Park
The Uttar Pradesh government is planning to establish a US FDA-accredited medical device testing laboratory to strengthen India’s growing medical device and pharmaceutical manufacturing ecosystem and support global exports.
The proposed facility will be set up under the Accreditation Scheme for Conformity Assessment (ASCA) at the upcoming UP Medical Devices Park, YEIDA, through a public–private partnership (PPP) model. The initiative aims to position Uttar Pradesh as a key regulatory and testing hub in the region.
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Enabling US Market Access
ASCA is a US FDA framework that verifies medical devices against globally accepted safety and quality standards. ASCA certification is critical for exporting medical devices to the US market. The lab will offer end-to-end testing, validation, and certification, reducing dependence on overseas testing facilities.
Bridging a Critical Gap in India
Globally, there are around 160 ASCA-accredited labs, mainly in the US and Canada, with limited presence in Europe and Asia. India currently has none, making this initiative strategically important for domestic manufacturers.
Boost for MSMEs and Exports
Once operational, the lab is expected to serve Indian and South-East Asian manufacturers, helping reduce compliance costs, shorten development timelines, and enable faster global market access—especially for MSMEs.
Discussions are ongoing to finalize the project framework, with tender-related processes expected to begin soon. The facility is expected to elevate quality benchmarks and enhance Uttar Pradesh’s role in the global medical device value chain.
Role of Operon Strategist
Operon Strategist supports medical device manufacturers in aligning products, testing strategies, and documentation with US FDA ASCA requirements for faster approvals. We help reduce regulatory risk and accelerate US market access through end-to-end FDA compliance expertise.
- Guide manufacturers on ASCA readiness and regulatory impact.
- Support US FDA submissions using ASCA-aligned test data.
- Align QMS, design controls, and risk management with FDA expectations.
- Help reduce testing costs and timelines, especially for MSMEs.
- Enable faster US market access and global exports through strategic regulatory planning.
