Apakah proses untuk memohon Akses Khas untuk peranti perubatan di Malaysia? | What is the process for applying for a Special Access for a medical device in Malaysia?

Untuk memohon Akses Khas bagi peranti perubatan di Malaysia, anda perlu mengikut keperluan seperti yang dinyatakan di Bahagian Special Access Medical Device. Disini disediakan garis panduan, borang yang diperlukan dan maklumat yang membantu anda membuat permohonan.

Pautan : https://portal.mda.gov.my/index.php/industry/exemption/special-access-medical-device

Untuk pertanyaan lanjut, sila hubungi 
BAHAGIAN KAWALAN PRA PASARAN (BKPP)
03 - 8230 0376

To apply for a Special Access for a medical device in Malaysia, you need to follow requirements as in the Special Access Medical Section. This section provides comprehensive guidelines, necessary forms, and regulatory information to help you navigate the Special Access process.

Link : https://portal.mda.gov.my/index.php/industry/exemption/special-access-medical-device

For further inquiries, please contact
PRE-MARKET CONTROL DIVISION (BKPP)
03 - 8230 0376