Apakah dokumen rujukan untuk pelabelan peranti perubatan Kelas A, B, C dan D? | What is the reference document for labelling requirement for Class A, B, C and D?

Dokumen panduan bagi rujukan keperluan pelabelan untuk peranti perubatan Kelas A, B, C dan D adalah Requirements of Labelling for Medical Devices (MDA/GD/0026). Keperluan pelabelan ini adalah terpakai untuk semua kelas peranti perubatan.

Alamat laman sesawang: https://portal.mda.gov.my/index.php/documents/guidance-documents/2297-guidance-document-labelling-requirements-for-medical-device-6th-edition-final

Carian manual: portal MDA > Industry > Medical Device Registration Information > Guidance Document > Pre-market Medical Device Registration > Pre-market Medical Device Registration (General Medical Device)

Guidance document for labelling requirement is referred to the Requirements of Labelling for Medical Devices (MDA/GD/0026). This labelling requirement is applied to all classes of medical device.

Website link: https://portal.mda.gov.my/index.php/documents/guidance-documents/2297-guidance-document-labelling-requirements-for-medical-device-6th-edition-final

Manual search: portal MDA > Industry > Medical Device Registration Information > Guidance Document > Pre-market Medical Device Registration > Pre-market Medical Device Registration (General Medical Device)