ABOUT THE STANDARDS ALLIANCE PHASE 2 (SA2)
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.
Medical device regulatory agencies that forgo relying on the regulations and standards of the global community must use their limited public health resources to develop agency and country-unique technical regulations. The Advanced Medical Technology Association (AdvaMed) estimates that the lack of global medical device regulatory convergence costs public health systems and the medical technology industry $4 billion per year, the majority of which occurs in developing countries.
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.