Bolehkah sesebuah establismen mempunyai/menjalankan pelbagai peranan? | Can an establishment have multiple roles?
Ya, sesebuah establismen boleh mempunyai pelbagai peranan, tetapi setiap peranan memerlukan lesen yang berasingan.
Contoh: Asiacare Medical Solutions Sdn Bhd mengilangkan beberapa peranti perubatan dan juga mengimport/mengedarkan yang lain. Mereka memerlukan ketiga-tiga lesen pengilang dan 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.
Yes, an establishment can have multiple roles, but each role requires a separate license.
Example: Asiacare Medical Solutions Sdn Bhd manufactures some medical devices and also imports/distributes others. They would need manufacturer's license and 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.