Online registration system for medical devices upgraded by CDSCO

The CDSCO has recently upgraded its online registration system and required all manufacturers of medical devices to re-submit their market standing certificates and non-conviction certificates, expanded to encompass improvements in the areas of the ease of doing business and efficiency in regulatory processes.

The market standing certificate is one which attests that a company has been fully licensed and continuously operating in the Indian market in its medical devices. The non-conviction certificate by the manufacturer or importer attests that he or she has, to date, not been convicted for matters related to product safety, quality, or its performance.

Meanwhile, it has been brought to the attention of the Central Government by the Association of Indian Medical Device Industry (AIMED) to put safeguard duties on 12 crucial categories of medical devices.

The association warned that uncontrolled imports are damaging domestic manufacturers and may worsen with ongoing trade negotiations with the EU and the US, which could further reduce duties on imports. As it was stated by AIMED, there could be under-utilization of capacities, financial losses, and downsizing for Indian manufacturers, and that could be at the same time increasing dependence on foreign suppliers unless intervention is timely.

AIMED mentions alarming imports of syringes and needles, which increased 80 percent, from $61 million to $111 million, because of growths in imports from China (69 percent), USA (91 percent), and Singapore (64 percent).

The association urges the government to act quickly for the sake of the local industry in saving jobs and keeping India self-reliant in healthcare manufacturing. Without action on an immediate basis, AIMED warns, the local industry may be invaded with cheaper imports and become unsustainable in the long run.