The Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health & Family Welfare, has recently clarified that refurbished medical devices and in-vitro diagnostic medical devices cannot be imported into India due to the absence of specific regulatory provisions.

In an official communication to the Principal Commissioner of Customs at IGI Airport, New Delhi, CDSCO emphasized that all medical devices in India are regulated under the Drugs and Cosmetics Act, 1940, and Medical Devices Rules, 2017. However, the existing framework does not include provisions for the regulation of refurbished medical devices, making their import legally unfeasible.

The clarification came in response to queries from customs authorities regarding the import of such devices. The notice, signed by Aseem Sahu, Deputy Drugs Controller (I), states that no license is issued for the import of refurbished medical devices, and therefore, they cannot be brought into the country for sale or distribution under the current Medical Devices Rules.

This move highlights India's stringent approach toward medical device regulation, ensuring that only new, certified devices meeting quality and safety standards enter the market. The restriction could impact the availability of cost-effective refurbished medical equipment, often sought by smaller healthcare providers and institutions.

The decision aligns with India's broader regulatory framework aimed at strengthening patient safety and healthcare standards. However, industry stakeholders may seek amendments to the rules to accommodate refurbished medical devices, provided they meet stringent quality and safety standards.

Dr. Sudhir Srivastava, Past Chair of the Medical Device Committee at PHDCCI, stated, “This decision by CDSCO marks a pivotal step towards reinforcing India’s self-reliance in medical technology. Allowing refurbished medical devices into the country would have jeopardized the quality of healthcare, disincentivized local innovation, and undermined the spirit of the ‘Make in India’ initiative. Indian manufacturers are making significant strides in R&D, delivering cutting-edge solutions tailored to our healthcare needs. By curbing refurbished imports, we not only protect the integrity of our medical ecosystem but also send a strong message to global investors that India is committed to building a robust, indigenous medical device industry. This move safeguards both the future of healthcare innovation in India and the well-being of our patients.”

Gaurav Agarwal, Managing Director, Innvolution Healthcare, said, “We welcome and applaud the clarity provided by the Central Drugs Standard Control Organisation (CDSCO) regarding the prohibition of importing refurbished medical devices under the Medical Devices Rules (MDR) 2017 for sale and distribution in India. This decisive clarification reinforces the regulatory framework designed to ensure the highest standards of patient safety while creating a robust environment for the growth of indigenous manufacturing. By eliminating ambiguity, CDSCO has further strengthened the push towards self-reliance, innovation, and quality in India’s medical technology sector, perfectly aligning with the 'Make in India' and 'Atmanirbhar Bharat' initiatives. Innvolution Healthcare remains committed to supporting these national objectives by delivering cutting-edge, locally manufactured solutions that enhance healthcare delivery and patient outcomes. We look forward to continued collaboration with regulators and stakeholders to advance India's position as a global leader in medical technology.”

Vishwaprasad Alva, Founder and Managing Director, Skanray Technologies, shared, “We don't allow second hand and refurbished cars, textile, printing, metal working machinery, into the country. Used medical equipment import was an error that the government corrected. It's the right move. India being a large nation and a growing market, apart from becoming a dumping ground for old unsafe medical equipment, we would have also become an e-waste destination for the world. The Government seems to be sensitive and serious about world class healthcare and also helping home grown manufacturing and R&D infrastructure.”