ADUAN PRESTASI DAN KESELAMATAN PERANTI PERUBATAN | MEDICAL DEVICE PERFORMANCE AND SAFETY COMPLAINTS
- Adakah pengguna perlu membuat aduan kepada MDA sekiranya didapati peranti perubatan mempunyai masalah keselamatan dan prestasi? | Should users report to the MDA if a medical device is found to have safety and performance issues?
- Saya tidak mendapat sebarang maklum balas aduan/kemalangan yang melibatkan peranti perubatan dari pembekal/syarikat. Siapakah yang saya perlu hubungi di MDA? | I have not received any feedback on complaints/accidents involving medical devices from the supplier/company. Who should I contact at MDA?
- Apakah cara untuk pengguna membuat aduan? | What are the ways for users to make a complaint?
- Apakah contoh aduan yang boleh dibuat? | What are some examples of complaints that can be made?
- Adakah peranti perubatan tiruan dikawal oleh MDA? | Are counterfeit medical devices regulated by the MDA?
- Apakah tindakan yang perlu diambil oleh establismen apabila menerima aduan? | What actions should establishments take when they receive a complaint?
- Adakah establismen perlu menyimpan rekod aduan yang diterima? | Does the establishment need to keep records of the complaints received?
- Adakah menjadi satu kesalahan jika establismen tiada rekod pengendalian aduan? | Is it an offense if the establishment does not have complaint handling records?