Medical device makers claim import of refurbished devices can harm industry
Medical device manufacturers in India have raised significant concerns regarding the importation of refurbished high-end medical equipment, such as CT scanners, MRI machines, and robotic surgical systems. Industry leaders argue that allowing these imports could undermine the domestic medical device sector, which is still developing, and pose risks to patient safety.
Industry Concerns:
- Impact on Domestic Manufacturing: The Association of Indian Medical Device Industry (AiMeD) asserts that permitting the import of pre-owned medical equipment threatens investments made under initiatives like ‘Make in India’ and ‘Aatmanirbhar Bharat’ (Self-Reliant India). They warn that such policies could turn these investments into non-performing assets, thereby hindering the growth of the domestic medical device industry.
- Patient Safety Risks: AiMeD highlights that imported refurbished devices are often inaccurately labeled, which can compromise patient safety. The lack of clear refurbishment guidelines in India allows for the importation of substandard equipment, increasing the risk of equipment failure and potential harm to patients.
- Economic Implications: Industry representatives note that hospitals and diagnostic centers charge patients the same fees regardless of whether they use new or refurbished equipment. This practice means that no cost benefits are passed on to patients, while outdated technology continues to be employed, potentially affecting the quality of healthcare services.
Regulatory Developments:
The Ministry of Environment, Forest, and Climate Change (MoEFCC) issued an Office Memorandum allowing the import of pre-owned medical equipment into India. Industry associations argue that this move undermines the National Medical Devices Policy 2023, which aims to promote domestic manufacturing and self-reliance in the medical device sector.
Industry Response:
In response to the MoEFCC’s decision, industry bodies such as AiMeD, the PHD Chamber of Commerce and Industry (PHDCCI), and the Manufacturers of Imaging, Therapy, and Radiology Devices Association (MITRA) have sought the intervention of Prime Minister Narendra Modi. They urge a ban on the import of refurbished medical devices that are already manufactured domestically, emphasizing the need to protect local manufacturers and ensure patient safety.
Global Perspective:
The global market for refurbished medical devices is projected to grow significantly, from USD 12.1 billion in 2020 to USD 21.2 billion by 2025, with an average annual growth rate of 11.8%. This growth is driven by factors such as the increasing privatization of healthcare and the need for cost-effective medical equipment. However, the importation of refurbished devices poses challenges, including quality assurance, performance reliability, and regulatory compliance.
