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.
Untuk pertanyaan lanjut, sila hubungi
BAHAGIAN KAWALAN PRA PASARAN (BKPP)
03 - 8230 0376
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.
For further inquiries, please contact
PRE-MARKET CONTROL DIVISION (BKPP)
03 - 8230 0376