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CDSCO bans import of refurbished medical devices in India.

Medical Technology

CDSCO, Ban, Refurbished, Medical Devices

Business Honor
16 January, 2025

CDSCO bans import of refurbished medical devices, sparking industry debate over access in underserved regions.

The new order from the Central Drugs Standard Control Organization (CDSCO) has put a stop on importing used or refurbished medical devices until an adequate policy framework is built into the system. This ban, coming as it did by a letter sent to the Principal Commissioner of Customs on January 10, could be based only on the so-called absence of regulations specifically targeted under the Medical Devices Rules, 2017.

While the move may be welcomed for the most parts by domestic manufacturing units, many argue that, on the grounds of healthcare concerns, the situation could have several knock-on impacts on healthcare operators, especially where access is at its worst, in the undeveloped segments. Industry respondents call for adequate regulatory support enabling the safe deployment and effective service of refurbished apparatuses while fueling the developing medical device marketplace in the home country.

Rajiv Nath, the forum coordinator of the Association of Indian Medical Device Industry (AiMED), welcomed the clarification from CDSCO, stating that it would further enhance self-reliance, innovation, and quality in India's medical technology sector. He added that the ban would also check the entry of unregulated, second-hand medical devices, which pose a threat to patient safety.

The Patient Safety and Access Initiative of India Foundation (PSAIIF) had previously raised concerns about the reliability and safety of refurbished devices through public interest litigation in the Delhi High Court. In response to the CDSCO’s decision, PSAIIF founder Prof. Bejon Kumar Misra called for the recall and destruction of illegally imported devices to ensure patient safety.

On the other hand, this ban is giving multinational companies a lot of headache because MNCs meet their demand largely from refurbished medical devices, mainly in Tier-II, -III, and -IV cities as well as in rural areas, as these have played a critical role in affording healthcare services in those unrepresented regions.

Experts are compelling the government to speed up making regulations on reused medical equipment. Key organizations such as Nathealth and MTaI called upon the need to implement policies expeditiously balancing safety and effectiveness with industrial development, giving the opportunity to operate in this competitive market, domestic and foreign companies alike.