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