Ficci Seeks Government Nod to Resume Import of Pre-Owned Medical Equipment
The Federation of Indian Chambers of Commerce and Industry (Ficci) has appealed to the government to restart the import of pre-owned and refurbished high-end medical equipment. This vital supply chain for cost-effective healthcare has been disrupted since August 15, 2024, due to updated registration requirements introduced by the Central Drugs Standard Control Organization (CDSCO).
Why the Imports Were Halted
Previously, importing refurbished medical devices was facilitated through a No Objection Certificate (NOC) from the Ministry of Environment, Forests & Climate Change. However, under the updated regulations, the Medical Device Rules (MDR) 2017 now mandate CDSCO registration for all imports, including pre-owned medical equipment.
CDSCO clarified that the current Medical Device Rules lack provisions for registering refurbished equipment. Consequently, the processing of previously submitted applications has come to a standstill, leaving healthcare providers without access to these cost-effective solutions.
Impact on the Healthcare Industry
The halt in imports has significantly affected healthcare providers, particularly in accessing affordable, high-value medical devices. These devices are crucial for diagnostic and therapeutic procedures across India’s medical facilities.
Ficci emphasized that restarting the import of refurbished equipment could help bridge gaps in affordability and accessibility, benefiting patients and hospitals alike.
Ficci’s Representation to the Government
In its appeal to the Ministry of Health, Ficci has requested:
- Immediate Revision of Rules: Introduce provisions in the Medical Device Rules to accommodate refurbished equipment.
- Interim Measures: Allow the import of pre-owned devices under the previous NOC system until updated rules are implemented.
This move, Ficci argues, will ensure continuity in healthcare services while aligning with the broader goal of cost-effective medical care.
What’s Next?
The government’s decision on Ficci’s representation will have far-reaching implications for the healthcare sector. With rising costs of medical equipment and increasing demand for affordable healthcare solutions, reintroducing pre-owned equipment imports could provide immediate relief to healthcare providers.
Conclusion
The suspension of refurbished medical equipment imports has highlighted the urgent need for regulatory updates. By revisiting and revising the Medical Device Rules, the government has the opportunity to support cost-effective healthcare solutions while maintaining safety and compliance.
Healthcare providers and industry stakeholders await a swift resolution to this pressing issue.
