Roll back approval to import used medical devices, med-tech industry urges PM

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Questioning the policy allowing the import of refurbished and pre-owned medical devices into the country, the Association of Indian Medical Devices, the Manufacturers of Imaging, Therapy and Radiology Devices Association, the Association of Diagnostic Manufacturers of India, and key stakeholders from the med-tech industry have appealed to the Prime Minister and the Health Ministry to withdraw this approval. The group said that the policy poses a significant threat to India’s self-reliance in medical device manufacturing.

The opposition comes from the industry after an office memorandums allowing the import of used medical devices was issued by the Ministry of Environment, Forest, and Climate Change, the Directorate General of Health Services, and the Ministry of Health & Family Welfare.

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“This development seems like 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,’’ said a press release issued by the group.

The group added that the memorandum significantly undermines the domestic med-tech sector, which has experienced significant growth and investment in recent years under the ‘Make in India’ initiative.

“Despite India’s ability to manufacture high-quality medical devices, allowing refurbished imports jeopardizes the hard-won progress made in the domestic sector. By favouring imported refurbished and used medical devices, this policy undermines the innovation and investments of Indian entrepreneurs, hindering the growth of a strong and competitive MedTech industry in India,’’ the release said.

It added that there are serious concerns about safety outcomes and the quality of patient care, as refurbished devices may not adhere to the stringent safety protocols required for new devices. This could potentially compromise patient well-being and diminish healthcare delivery. The reliance on refurbished imports not only threatens the industry but causes trauma to startups and MSMEs, leading to the potential shutdown of manufacturing units, it said.