Unregulated Import of Refurbished Medical Devices Poses Risks to Patient Safety in India

Sunday, 27 October 2024, 00:00

New Delhi's medical device manufacturers are raising serious alarms regarding the unregulated import of refurbished medical devices. This concern emphasizes potential risks to patient safety, particularly with second-hand equipment like CT scanners and MRI machines. The industry calls for an urgent review of regulatory standards to ensure that patient safety is not compromised amid the push for high-value medical equipment.
Medicaldialogues
Unregulated Import of Refurbished Medical Devices Poses Risks to Patient Safety in India

Overview of Current Concerns

In a recent development, New Delhi's medical device manufacturers highlighted alarming accounts regarding the unregulated import of refurbished medical devices. They stress that the potential risks to patient safety associated with these foreign second-hand equipments such as CT scanners and MRI machines are serious.

Impact on Patient Safety

  • Patient safety has become a pressing issue as unverified devices enter the market.
  • The need for stringent regulatory standards is more critical than ever.
  • High-end medical equipment is being overshadowed by these unsafe imports.

Calls to Action from Industry Leaders

Rajiv Nath of the medical devices industry advocates for the enforcement of the National Medical Devices Policy, 2023, aimed at supporting Make in India initiatives. He argues that unregulated imports conflict directly with the country’s goal of self-reliance in healthcare.

Legal Actions and Responses

  1. The Patient Safety and Access Initiative of India Foundation (PSAIIF) has filed a Public Interest Litigation (PIL).
  2. They seek clarity from the Delhi High Court on the conflicting stances taken by the Ministry of Environment, Forest, and Climate Change and Director General of Health Services.

Conclusion on Regulatory Standards

This situation poses significant risks not only to patient safety but also to the future of India’s burgeoning healthcare technology landscape. It is imperative for all stakeholders to ensure that only compliant and safe medical devices enter the Indian market.


This article was prepared using information from open sources in accordance with the principles of Ethical Policy. The editorial team is not responsible for absolute accuracy, as it relies on data from the sources referenced.


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