Workshop held to advance risk-based medical device regulation

Kathmandu, Bagmati province - The Department of Drug Administration (DDA) under the Ministry of Health and Food Safety (MoHFS), with support from WHO Country Office for Nepal, convened a national workshop on medical device regulation on 6 August. The workshop brought together 39 drug regulators, procurement officials and representatives from hospitals to support the development and implementation of a risk-based regulatory framework for medical devices in Nepal.

Participants discussed key regulatory provisions that need to be  incorporated in the revised Drug Act, including institutional preparedness, regulatory pathways, implementation approaches and workforce capacity. The workshop also provided an opportunity to review WHO guidance and international good practices on medical device regulation, including risk classification, market authorization, quality management systems, vigilance, post-market surveillance and regulatory reliance.

The workshop contributed to deepening the understanding of the regulatory reforms needed for medical devices in Nepal, including reducing the risk of substandard, unsafe, ineffective or poorly maintained products reaching health services, while improving access to quality-assured medical devices across the country.