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7 September 2026

India Proposes Shared Testing Facilities to Help Medical Devices Meet Global Standards

The facilities would allow Indian equipment to be tested, compared with international benchmarks, certified and demonstrated to buyers. Their commercial value will depend on whether the resulting evidence is accepted by regulators in India and overseas

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Key Details

At the Pharma Machtech and Labnext Expo 2026, Commerce and Industry Minister Piyush Goyal proposed shared facilities to support Indian manufacturers of medical devices, laboratory equipment and related products.

  • Functions: Testing, international benchmarking, certification and demonstrations for prospective customers.

  • Location model: Facilities could be housed in government-supported or university laboratories.

  • Government role: Support the acquisition of advanced technical testing equipment.

  • Intended users: Medical-equipment manufacturers, startups and other firms that may not have their own specialised testing infrastructure.

  • Export link: Help Indian products demonstrate compliance and use the market access created by free trade agreements.

  • Status: This is a ministerial proposal. The release does not announce a scheme, budget, location, product coverage or implementation schedule.

Medical devices in India are regulated by the Central Drugs Standard Control Organisation (CDSCO) under the Drugs and Cosmetics Act, 1940 and the Medical Devices Rules, 2017. Laboratories testing devices for manufacturers can be registered under these rules and require accreditation from the National Accreditation Board for Testing and Calibration Laboratories (NABL) or another notified body.


The Proposal Targets a Specific Barrier to Commercialisation

Developing a medical device is not enough to place it in a hospital or export market. Manufacturers must produce credible evidence that the product meets the required standards for safety, quality and performance.

Shared facilities could give firms access to specialised equipment for generating this evidence. This is particularly relevant for startups and smaller manufacturers for whom maintaining a complete testing facility may be prohibitively expensive.


Testing in India Must Be Accepted Where Products Are Sold

The proposal links testing infrastructure with India’s ambition to export more medical equipment. Free trade agreements may reduce tariffs, but they do not remove the technical and regulatory requirements applied to healthcare products.

The decisive issue is therefore not simply whether a product has been tested in India, but whether the laboratory, testing method and documentation are recognised in the destination market. Internationally accepted accreditation and regulatory cooperation could reduce the need for manufacturers to repeat the same tests abroad.


The Approach Reflects a Wider Laboratory-to-Market Policy Position

The testing proposal complements the government’s call to involve commercial partners from the beginning of publicly supported research, allowing product design and market requirements to shape technologies before development is complete.

It also follows efforts to connect startups and manufacturers with public laboratories offering technologies for licensing and commercial adoption. At the Kolkata RISE Conclave, four laboratories under the Council of Scientific and Industrial Research reported four technology transfers, eight memoranda of understanding and two product launches.

Together, these developments reflect a government position that public laboratories should support a longer commercialisation pathway: industry input during research, technology transfer, product testing and eventual market entry.


Global Partnerships Remain Part of the Medtech Strategy

The address also supported co-design, joint development, licensing and technology transfer with overseas firms and research centres. The proposed direction combines domestic manufacturing with access to international knowledge rather than treating the two as alternatives.

For Indian firms, shared testing facilities could support both pathways: validating products developed domestically and adapting licensed or jointly developed technologies for production in India.


Policy Relevance

Shared testing infrastructure could fill the gap between producing a prototype and establishing that it is ready for regulated healthcare markets. The design of the facilities will determine whether they become useful commercial infrastructure or simply additions to the public laboratory network.

  • Access must extend beyond established companies: Transparent fees, booking rules and technical assistance will shape whether startups and smaller manufacturers can use the facilities.

  • Testing and regulation must remain connected: CDSCO requirements, NABL accreditation and the services offered by the new facilities will need to align. A laboratory test does not by itself replace product approval, quality-control requirements or clinical evidence where these are required.

  • Overseas recognition will determine export value: Facilities should be designed around the standards and documentation required in target markets. Mutual recognition arrangements and regulator-to-regulator cooperation could make Indian test reports more readily usable abroad.

  • Performance should be measured through products, not equipment purchased: Relevant indicators include products tested, approval timelines, repeated overseas tests avoided and devices reaching domestic or export markets.


Relevant Question for Policy Stakeholders: How will the proposed shared facilities be accredited and linked with overseas regulators so that tests completed in India are accepted in major export markets?


Follow the Full Speech Update Here: Commerce Minister’s Address on Medical Technology, Healthcare and Exports

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