Apakah proses untuk memasukkan Surat Kuasa (LOA) tambahan kepada permohonan lesen sedia ada? | What is the process for including an additional Letter of Authorization (LOA) to an existing license?

Establismen mesti membuat “Amendment Minor” dalam sistem Medcast 2.0 dan melampirkan LOA baharu, serta sijil QMS dan laporan audit yang dikemas kini (jika berkenaan).

Contoh: Pengimport sedia ada mendapat kebenaran untuk mengimport peranti dari AR baharu. Mereka perlu menghantar dokumen yang diperlukan termasuk kebenaran baharu kepada lesen mereka.

The establishment must Make an application for an amendment to the minor application in the Medcast 2.0 system and attach together the new LOA, and an updated QMS certificate and audit report (if applicable).

Example: An existing importer obtains authorization to import devices from a new AR . They would need to submit the documents required including the new authorization to their license.