Egypt's position as the second-largest medical device market in the MENA region, combined with its low local production, makes it a highly import-dependent market. Recent regulatory changes to the EDA Egypt medical device registration process, including the participation of foreign manufacturers in public tenders through registration with the Unified Procurement Authority (UPA), have further opened the market to international companies.
This week in medical device regulatory news, the European Commission has updated official guidance on the classification of IVDs under the IVDR; Brazil has opened public consultation on UDI database management and suspended electronic signature requirements; and China revised its regulations on domestic production of imported medical devices.
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