Consider the following statements regarding the regulatory framework governing single-use medical devices (SUDs) and their reprocessing in India:

Statements

1. Under India's Medical Devices Rules, 2017, the Central Drugs Standard Control Organisation (CDSCO) is the primary regulatory authority for the classification, licensing and post-market surveillance of medical devices, including the determination of single-use versus reusable designations.
2. A single-use device (SUD) labelled by its manufacturer as non-reusable may nonetheless be legally reprocessed and reused in India provided that validated sterilisation protocols, functional testing and patient consent requirements are fulfilled, as these conditions override the original manufacturer's classification.
3. The risks associated with reprocessing single-use medical devices include cross-infection, device malfunction and loss of performance — concerns that inform the rationale for regulatory restrictions on SUD reuse.