Informasi dari USAID

COVID-19 Medical Device Regulatory Convergence Project (MDRC)

 

Amidst the COVID-19 pandemic, nations have scrambled to increase production and access to medical devices to prevent and treat the virus, such as rapid diagnostic test kits, ventilators, and personal protective equipment (PPE). However, countries cannot safely deploy these products without a strong medical device regulatory framework and knowledge of emergency use authorization (EUA) procedures and rules.

The Standards Alliance Phase 2 COVID-19 Medical Device Regulatory Convergence Project (MDRC) increases the transparency and predictability of partner governments’ regulatory ecosystems for medical devices, aligning them with international standards, and improving their overall National Quality Infrastructure.

For further information related to the project, please access the following link  USAID MDRC Fact Sheet

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