Adakah lesen berasingan diperlukan untuk mengeksport peranti perubatan? | Is a separate license required for importing medical devices?

Ya, di bawah rangka kerja lesen tunggal, establismen dikehendaki mendapatkan lesen berasingan untuk setiap peranan yang mereka ingin jalankan.

Contoh: Pengedar peranti perubatan dalam negeri hanya memerlukan lesen pengedar. sekiranya mereka ingin melaksanakan aktiviti pengimportan peranti perbuatan, mereka perlu mendapatkan lesen establishmen untuk peranan pengimport.

Yes, under the single license framework, establishments are required to obtain separate licenses for each of the roles that they intend to conduct.

Example: A distributor of medical devices domestically would only need a distributor license. If they are conducting importation activities then they will need to obtain the import the license.