Siapa yang perlu mendapatkan lesen establismen? | Who needs to obtain an establishment license?

Mana-mana individu atau syarikat yang mengeluarkan, mengimport, mengeksport, atau mengedarkan peranti perubatan di Malaysia perlu mendapatkan lesen establismen. Ini termasuk:

• Pengilang
• Perwakilan yang sah (AR)
• Pengimport
• Pengedar

Contoh: Syarikat MalayMed Innovations Sdn Bhd mengeluarkan sarung tangan pembedahan di Malaysia. Mereka perlu memohon lesen establismen bagi peranan pengilang.

Any person or company that manufactures, imports, exports, or distributes medical devices in Malaysia needs to obtain an establishment license. This includes:

• Manufacturers
• Authorized Representatives (AR)
• Importers
• Distributors

Example: Company MalayMed Innovations Sdn Bhd manufactures surgical gloves in Malaysia. They would need to apply for a manufacturer's establishment license.