Bolehkah Arahan Penggunaan (IFU) atau Pacakge Insert untuk produk kombinasi siap ubat-gabungan peranti perubatan diterima oleh MDA? | Can Instruction for use (IFU) or Package Insert for the finished drug-medical device combination product be accepted by MDA?
Ya, ianya diterima.
Yes, the IFU and package insert can be accepted for a single-entity combination product.