Selepas mencipta akaun MeDC@St, adakah saya perlu memohon lesen establismen, pendaftaran peranti perubatan, atau kedua-duanya? | After creating a MeDC@St account, do I need to apply for an establishment license, medical device registration, or both?

Semua establismen (pengilang, perwakilan yang sah, pengimport, dan pengedar) mesti memohon lesen establismen. Walau bagaimanapun, hanya pengilang dan perwakilan yang sah (AR) perlu memohon pendaftaran peranti perubatan.

Contoh: Jika anda seorang pengedar, anda hanya perlu memohon lesen establismen. Jika anda seorang pengilang, anda memerlukan kedua-dua lesen establismen dan pendaftaran peranti perubatan anda.

All establishments (manufacturers, authorized representatives, importers, and distributors) must apply for an establishment license. However, only manufacturers and authorized representatives (ARs) need to apply for medical device registration.

Example: If you're a distributor, you only need to apply for an establishment license. If you're a manufacturer, you'll need both an establishment license and to register your medical devices.