The Ministry of Food and Drug Safety (MFDS) of the Republic of Korea proposes amendments to the following provisions of the Enforcement Rule of the Digital Medical Products Act. – Notification and notification of change of digital medical or health support devices – Standards and procedures for performance certification of digital medical or health support devices – Standard and procedures for designating performance inspection agencies – Formulation and implementation of distribution management plans for digital medical or health support devices – Issuance of Order and publication regarding recall, exchange, destruction, or suspension of distribution of digital medical or health support devices.
South Korea – Proposed Amendments to the «Enforcement Rule of the Digital Medical Products Act»
