Apakah pengujian yang diperlukan bagi produk pelitup muka untuk tujuan perubatan / surgikal? | What are the type of testing required for medical or surgical face mask?

Pengujian yang diperlukan bagi peranti perubatan pelitup muka jenis perubatan / surgikal telah diperincikan dalam dokumen panduan Medical Face Mask and Respirator (MDA/GD/0033) yang boleh dimuat turun melalui pautan berikut: https://portal.mda.gov.my/index.php/documents/guidance-documents/2608-medical-face-mask-and-respirator-third-edition

Carian manual: portal MDA > Industry > Medical Device Registration Information > Guidance Document > Pre-market Medical Device Registration > Medical Device Specific Requirements

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

Testing required for medical device or surgical face mask can be referred to the guidance document Medical Face Mask and Respirator ( MDA/GD/0033) at the provided link below:https://portal.mda.gov.my/index.php/documents/guidance-documents/2608-medical-face-mask-and-respirator-third-edition

Manual searching: portal MDA > Industry > Medical Device Registration Information > Guidance Document > Pre-market Medical Device Registration > Medical Device Specific Requirements

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