TINDAKAN PEMBETULAN DI LAPANGAN | FIELD CORRECTIVE ACTION (FCA)
- Apakah itu tindakan pembetulan di lapangan (FCA)? | What is Field Corrective Action (FCA)?
- Siapakah yang perlu membuat notifikasi tindakan pembetulan di lapangan kepada MDA? | Who is responsible for notifying MDA on FCA?
- Adakah pengedar dan pengimport perlu membuat notifikasi tindakan pembetulan di lapangan? | Do distributors and importers have to make a notification on field corrective action?
- Bagaimanakah cara untuk establismen membuat notifikasi tindakan pembetulan di lapangan kepada MDA? | How can an establishment notify the MDA on Field Corrective Action?
- Adakah MDA akan melakukan pemeriksaan terhadap tindakan pembetulan di lapangan yang dijalankan oleh establismen? | Will MDA conduct inspections on the corrective actions carried out by the establishment?
- Adakah establismen perlu melaporkan tindakan pembetulan di lapangan mengikut setiap peranti perubatan yang terlibat? | Does the establishment need to report the corrective actions in the field for each involved medical device?
- Bagaimanakah cara untuk menambah sebarang maklumat baru di dalam laporan tindakan pembetulan di lapangan yang telah dibuat melalui MeDCReSt? | Can establishment upload new information which is to be added to the FCA report that has already been made through MeDCReSt?
- Adakah Notis Keselamatan di Lapangan (Field Safety Notice {FSN}) perlu disebarkan kepada semua pengguna yang terlibat? | Does the Field Safety Notice (FSN) need to be distributed to all affected users?
- Peranti perubatan saya berdaftar tetapi tiada dalam pasaran Malaysia. Adakah saya perlu membuat notifikasi FCA? | My medical device is registered but not available in the Malaysian market. Do I need to make an FCA notification?
- Jika FCA tersebut melibatkan sebarang pengubahsuaian peranti perubatan termasuk kemas kini label/IFU, apakah yang perlu dilakukan oleh establismen? | If the FCA involves any modification of the medical device, including updating the label/IFU, what does the establishment need to do?
- Bolehkah establismen memohon pelanjutan masa bagi menyelesaikan laporan tindakan pembetulan di lapangan? | Can the establishment request an extension of time to complete the field corrective action?
- Apakah langkah yang diperlukan untuk menutup tindakan pembetulan di lapangan? | What are the steps required to close the field corrective action?