Government Bans Import of Refurbished Medical Devices
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has issued a directive to halt the import of refurbished medical devices, citing the absence of specific regulations under the Medical Devices Rules, 2017.
The directive, issued through a letter dated January 10, 2025, to the Principal Commissioner of Customs, emphasizes that such devices cannot be imported for sale or distribution due to the lack of licensing provisions.
The CDSCO's move aims to address concerns over the safety and reliability of refurbished medical equipment entering the Indian market without proper certification. "The clarification by the regulator is a welcome move and a huge 'Make in India' investment enabler," Rajiv Nath, forum coordinator of the Association of Indian Medical Device Industry (AiMED), told Economic Times.
The decision also follows growing alarm among industry stakeholders about the potential risks to patient safety. Last year, the Patient Safety and Access Initiative of India Foundation (PSAIIF) filed a public interest litigation in the Delhi High Court, flagging the hazards posed by these devices.
While the domestic medical device industry has praised the move, others have raised concerns about its impact on underserved areas. The Medical Technology Association of India (MTaI) estimates that pre-owned medical equipment accounts for 10% of India's Rs 1,500 crore medical equipment industry, playing a vital role in meeting the demand for affordable healthcare solutions in Tier-II, Tier-III, and rural areas.
“The government has suspended all imports of refurbished medical devices until a policy framework is established,” MTaI said in a statement reviewed by Fortune India. “To avoid disruptions, it is essential to allow imports through necessary approvals in the interim.”
Jitendra Sharma, Managing Director of the Andhra Pradesh MedTech Zone, hailed the decision, describing it as a "true policy intervention that will guard the domestic industry against dumping of equipment with uncertain quality." He further noted that the move would promote patient safety and bolster the local manufacturing sector, as quoted in ET.
The Ministry of Health and Family Welfare is now working on forming a high-level expert committee to create a regulatory framework for refurbished medical devices. In the meantime, all consignments containing such devices currently held at ports will need to be returned, Deputy Drugs Controller (India) Aseem Sahu said at a recent workshop co-hosted by CDSCO and the Confederation of Indian Industry (CII), reports Business Standard.
The import of refurbished devices was previously allowed under the Hazardous and Other Wastes (Management and Transboundary Movement) Second Amendment Rules, 2023, enacted by the Ministry of Environment, Forest and Climate Change (MoEFCC). The rules permitted imports of devices up to five years old, with a list initially comprising 50 high-value medical devices but later trimmed to 38 in October 2024.
Rajiv Nath highlighted that India does not allow the import of pre-owned cars or iPhones and argued for a similar stance on refurbished medical devices. "We welcome multinational corporations to invest in India and manufacture these high-technology devices locally, similar to the automobile and mobile phone sectors. A healthy competition is always welcome," he told ET.
The CDSCO's action reflects a broader push to align with the National Medical Devices Policy, 2023, which envisions India as a global hub for medical device manufacturing. “We hope the policy review will consider this alignment and address patient safety concerns while fostering a robust domestic manufacturing ecosystem,” Nath told Fortune India.
While the industry waits for a regulatory framework, the halt on imports has sparked a debate over the balance between patient safety, domestic manufacturing, and the need to ensure affordable healthcare in underserved regions.
