DTAB Proposes Clearer Regulatory Definition for IVD Medical Devices

The Drugs Technical Advisory Board (DTAB) has recommended an amendment to India’s Medical Devices Rules, 2017, to introduce a clearer and more comprehensive definition of in vitro diagnostic (IVD) medical devices.

The recommendation was considered during the board’s 94th meeting held on August 27, 2026. At present, the Medical Devices Rules refer to substances used for in vitro diagnosis as IVD medical devices, but do not provide a detailed definition covering the wider range of products used in modern diagnostic testing.

Under the proposed amendment, the definition would encompass products such as diagnostic kits, reagents, calibrators, control materials and specimen receptacles. It would also cover software, instruments, analysers, systems and other related articles that manufacturers intend to use, either individually or together, for examining specimens obtained from humans or animals.

The proposed wording identifies several purposes for which such devices may be used, including diagnosis, screening, monitoring, prediction, prognosis, determination of physiological status and assessment of compatibility. The move is intended to bring greater clarity to the regulatory treatment of IVD products in India.

DTAB noted that separate definitions for medical devices and IVD medical devices are already established internationally. Aligning India's terminology with global regulatory frameworks could provide greater consistency in how these products are classified and regulated.

The proposal had also been examined by the Medical Device Technical Advisory Group during a meeting in May 2026. The latest recommendation is therefore part of a wider effort to refine the regulatory framework governing medical devices in the country.

The board also recommended amendments concerning information required for testing medical devices at Medical Device Testing Laboratories, indicating broader regulatory changes under consideration for India's medical-device sector.

30-09-2026