MoEFCC accused of National Medical Devices Policy violations by Industry Associations

The PHD Chamber of Commerce and Industry (PHDCCI) and the Association of Indian Medical Devices (AiMed), in alliance with the Manufacturers of Imaging, Therapy and Radiology Devices Association (MITRA), the Association of Diagnostic Manufacturers of India (ADMI), and key stakeholders from the MedTech industry, recently held a press meet at PHD House to discuss serious concerns regarding recent Office Memorandums 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, despite similar devices being manufactured in India. Industry leaders believe this poses a significant threat to India’s self-reliance in medical device manufacturing, undermining the nation’s efforts under the Prime Minister's vision of 'Make in India' and 'Aatmanirbhar Bharat' initiatives.

This development is seen as a major setback for domestic manufacturing capabilities and India’s push toward self-sufficiency. Additionally, concerns have been raised about potential risks to patient safety, as refurbished devices may not meet the rigorous quality standards of newly manufactured equipment, further intensifying the issue.  

Refurbished devices, which undergo repairs and cosmetic updates, cannot replicate the functionality and reliability of new equipment. New medical devices maintain optimal performance throughout their lifecycle, typically lasting around ten years, while refurbished options may show diminished functionality due to prior use.

Additionally, refurbished devices often lack the latest technological advancements and come with lower warranties, inadequate service support, and higher failure rates, all of which can impact the quality of treatment and surgical outcomes.

In light of these issues, industry leaders collectively urged the Prime Minister to address the current challenges and order an immediate ban on the import of refurbished devices that are manufactured locally. They emphasised the importance of aligning policies with national manufacturing initiatives to support domestic manufacturers and reduce reliance on imports. Furthermore, they called for enhanced post-market surveillance to monitor the safety and effectiveness of all medical devices used in India, ensuring that patient safety remains a top priority.