The representative of the United States provided the following statement. We had a very quick bilateral with India prior to this STC and there is some information in our background about the specific QCOs in question that we will add to one of the talking points after the meeting. The United States understands that the Ministry of Health and Family Welfare notified the Medical Device Rules (MDR) to the Gazette of India in January 2017 and that MDR entered into force in January 2018. We recognize and share India's goal of ensuring the quality, safety and efficacy of medical devices. Our concern pertains to MDR Rule 7 on Product Standards for Medical Devices, which requires medical devices to conform to standards set by the Bureau of Indian Standards (BIS). According to MDR Rule 7, ISO, IEC, or other pharmacopeial standards may be applied only when a BIS standard is unavailable. India recently restated this requirement in a May 2024 circular on testing and evaluation of medical devices. In addition, we are particularly concerned about the increasing number of mandatory quality control orders and regulatory schemes impacting medical device parts and components, which can create unnecessarily burdensome, costly, and duplicative requirements for trading partners. Would India please explain the rationale behind mandating compliance to domestic standards developed by BIS when relevant international standards exist, as opposed to encouraging voluntary compliance or continuing to recognize international standards? Has India considered how the imposition of its own standards may create a bifurcated system inconsistent with its participation in ISO/IEC committees as well as its stated goals of regulatory convergence and creating its own innovative domestic industry? The United States requests that India amend MDR Rule 7 and consider alternative approaches to compliance that are no more trade restrictive than necessary to meet its legitimate objectives.

In response, the representative of India provided the following statement. India thanks USA for their interest in Medical Devices Rules 2017. The objective of Indian Medical Devices Rules, 2017 is to have specific regulatory requirement for medical devices in respect of its import, manufacture, clinical investigation, sale and distribution in the country by ensuring quality, safety and performance of the medical devices. As far as product standard for medical devices is concerned, under the Rule 7 of the Indian Medical Devices Rules, 2017 the Bureau of Indian Standards (BIS) is made mandatory as they are the National Standards Setting Body responsible for preparation and formulation of standards for medical devices in the country. The BIS is also an active "P" member in the ISO/IEC committees involved in the harmonization of Indian standards in the line of international standards. Most of the ISO/IEC standards are being adopted by the BIS for the medical devices. Further, the scope of the international standards such as ISO/IEC is also incorporated in the said rule if there is no BIS standard available for medical device. Additionally, this is the first time this issue is raised in the TBT Committee meeting. We had a brief discussion with USA on the sidelines of TBT Committee meeting to understand their concern in detail. We had taken note of the concerns of USA and have communicated the same to our regulator. We may share the detailed response in due course.