Roll back nod given to import used medical devices

Sub : Eco

Sec: External Sector

Context:

Key stakeholders from the Indian med-tech industry, including the Association of Indian Medical Devices, the Manufacturers of Imaging, Therapy and Radiology Devices Association, and the Association of Diagnostic Manufacturers of India, have expressed strong opposition to the recent policy allowing the import of refurbished and pre-owned medical devices.

Background:

Recently office memorandums were issued by the Ministry of Environment, Forest, and Climate Change (MoEFCC), the Directorate General of Health Services (DGHS), and the Ministry of Health & Family Welfare (MoHFW).
These memorandums permit the import of refurbished and pre-owned medical devices.
The policy aims to provide cost-effective medical solutions, particularly in underserved regions, by facilitating access to refurbished medical equipment.

Concerns raised:

Threat to Domestic Manufacturing: It is argued that importing used medical devices undermines progress in domestic manufacturing and represents a significant setback to India’s self-sufficiency in the medical device sector.
Patient Safety risks: The group warns that refurbished medical devices may not meet strict quality standards, raising concerns about patient safety and the reliability of healthcare using these imports.
Impact on Innovation and Investment: Stakeholders contend that allowing refurbished imports undermines India’s ability to produce high-quality medical devices, stifles innovation, deters investment, and could hinder the growth of the domestic med-tech industry.