Adakah peruncit perlu mendapatkan lesen establismen? | Do retailers need to obtain an establishment license?

Secara umumnya, peruncit tidak perlu mendapatkan lesen establismen. Walau bagaimanapun, jika peruncit terlibat dalam aktiviti pengeluaran, pengimportan, pengeksportan, atau pengedaran, mereka perlu mendapatkan lesen yang bersesuaian.

Contoh: Johor Pharmacy, sebuah farmasi yang hanya menjual peranti perubatan kepada pengguna akhir tidak memerlukan lesen. Namun, jika mereka mula mengimport/mengedarkan peranti dari pengilang luar negara, mereka perlu mendapatkan lesen pengimport/pengedar.

Selain itu, jika mereka dilantik sebagai perwakilan yang sah untuk peranti perubatan yang mereka peroleh dari pengilang asing, maka mereka juga perlu mendapatkan lesen perwakilan yang sah.

 

Generally, retailers do not need to obtain an establishment license. However, if a retailer engages in manufacturing, importing, exporting, or distribution activities, they will need to obtain the corresponding license.

Example: Johor Pharmacy, a pharmacy store that only sells medical devices to end-users doesn't need a license. However, if they start importing/distributing devices from overseas manufacturers, they would need to obtain an importer/distributor license.

On top of that, if they are being appointed as the authorized representative for medical devices that they obtain from foreign manufacturer, then they should obtain an authorized representative license as well.