Bolehkah laporan analisis risiko yang mengambil kira produk kombinasi siap ubat-peranti perubatan diterima oleh MDA? | Can a risk analysis report that accounts for the finished drug-medical device combination product be accepted by MDA?

Ya, ianya diterima.

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

Yes, the report can be accepted for a single-entity combination product.

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