DTAB Proposes Wider Exemption For Home-Use Medical Devices

The sale of several commonly used medical devices used at home and in first-aid kits, such as pulse oximeters, blood pressure monitors and thermometers could soon become simpler.

The Drugs Technical Advisory Board (DTAB) has made such a proposal, recommending widening the exemptions from sale-licence requirements under the Medical Devices Rules, 2017.

The proposed changes cover a range of products used at home and in first-aid kits, including pulse oximeters, blood pressure monitors, thermometers, urine pregnancy test kits and glucometers. The Board has also recommended exemptions for small quantities of medical devices brought to exhibitions for display and demonstration.

The recommendations were made at the 94th meeting of DTAB held recently and are aimed, among other things, at easing regulatory requirements for products that are generally used directly by consumers or for limited, non-commercial purposes.

At present, the Eighth Schedule of the Medical Devices Rules specifies certain categories of devices that are exempt from provisions of Chapter XI, which deals with requirements including a sale licence.

The existing exemption includes certain medicated dressings and bandages used for first aid, provided they have been manufactured by licensed manufacturers. DTAB has now recommended expanding this entry to cover a broader range of first-aid and self-testing devices.

The proposed list includes first-aid kits containing items such as bandages, cotton gauze, resuscitation masks, adhesive tape and thermometers. It also includes absorbent cotton wool, bandages, absorbent gauze and adhesive plaster.

The distinction is significant because these are devices increasingly used outside hospitals and clinics. Requiring a sale licence for every such product can add regulatory layers to their distribution even when they are being supplied for routine consumer use.

However, the recommendation does not mean that such devices would be outside the regulatory framework altogether. The exemptions would operate subject to conditions prescribed under the rules.

The DTAB has also recommended easing requirements for imported first-aid kits meant for the captive use of industries that are not healthcare providers.

This could cover sectors such as automobile companies and the hospitality industry, where first-aid kits may be maintained for employees, visitors or workplace emergencies but are not intended for commercial sale.

The Board considered representations seeking exemption from both the import-licence requirement under Chapter V and the sale-licence requirement under Chapter XI of the Medical Devices Rules.

“DTAB opined that, in order to ease the process of import of these first aid kits from the point of view of Ease of Doing Business, such kits may be exempted from the requirements of Chapter V of the Medical Devices Rules, 2017, which require them to be covered by a license for import, as well as the requirements of Chapter XI of these Rules, which require them to be covered by a sale license....,” the Board said in the minutes of its meeting.

There are, however, safeguards attached to the proposed exemption.

The imported first-aid kits should have at least 60% residual shelf life at the time of import and must comply with applicable standards. The kits would also be meant strictly for captive consumption and cannot be resold or distributed.

The proposals had earlier been deliberated by the Medical Device Technical Advisory Group (MDTAG) at its meeting on May 14, 2026.

The Eighth Schedule is important because it specifies categories of medical devices that are exempt from certain provisions of the Medical Devices Rules, 2017.

The schedule also provides exemptions for certain devices supplied by government or local-body hospitals and dispensaries, as well as mechanical contraceptives, subject to specified conditions.

Another existing provision allows small quantities of medical devices donated to charitable hospitals for treating patients free of cost to be imported without an import licence, provided the Central Licensing Authority issues a No Objection Certificate.

The latest DTAB recommendations therefore represent an expansion of an existing exemption framework rather than a move to remove medical devices from regulation.

For consumers, the practical significance could be greater availability of commonly used home-testing and first-aid products without unnecessary regulatory hurdles. For businesses, particularly those importing first-aid kits solely for workplace use, the proposed changes could reduce compliance requirements.