PINDAAN PENDAFTARAN PERANTI PERUBATAN | CHANGE NOTIFICATION OF REGISTERED MEDICAL DEVICE
- Adakah pindaan peranti perubatan bagi semua kelas (A, B, C dan D) perlu dimaklumkan kepada Pihak Berkuasa Peranti Perubatan? | Are amendment of all medical device classes (Class A, B, C and D) required to be notified to Medical Device Authority?
- Apakah maksud pindaan editorial? | What is consider as an editorial change?
- Apakah kategori-kategori pindaan bagi peranti perubatan yang berdaftar? | What are the different categories of changes for medical devices
- Apakah kategori pindaan bagi penambahan, penukaran atau pengurangan pada senarai tapak pengilangan / tapak Pengilangan? | What are the categories of amendments for additions, changes or reductions to the list of manufacturing sites?
- Apakah kategori pindaan bagi maklumat pembuat dan tapak pengilang/ Pengilangan? | What are the categories of changes applied for amendment of manufacturer information and manufacturing site?
- Terdapat keperluan pindaan bagi proses pengilangan melibatkan penukaran peralatan yang digunakan untuk tujuan pemotongan suture. Perubahan peralatan ini telah menyebabkan panjang suture menjadi lebih pendek. Apakah kategori pindaan yang perlu dibuat bagi perubahan pada proses Pengilangan/ pengilangan? | There is an amendment for the manufacturing process involving the change of equipment used for the purpose of cutting sutures. This new equipment has cause change in sutures specification to be a bit shorter. What type category of changes applied for the change of the manufacturing process?
- Apakah kategori pindaan bagi penukaran kaedah pensterilan yang ditukar daripada etilena oksida (EO) kepada sinaran gamma? | Please advise, what is the category of changes applied for changes of the sterilization method from ethylene oxide (EO) to gamma radiation.