Senin, 28 Januari 2013

Registration Requirements for registrating non electromedic medical device (According to the Registration website) :


Form A
  1. Formulir Permohonan / Application form
  2. IPAK (Ijin Penyalur Alat Kesehatan) / Medical Device Distribution License
  3. LOA / Letter of Appointment : legalized
  4. CFS / Certificate of Free Sale : legalized
  5. ISO 13485
  6. Pernyataan merk dan surat pernyataan bersedia melepas keagenan / Statement of Brand and Statement letter to willingly give in the distributor rights if there are other party more eligible.
 Form B
  1. Uraian Alat / Description of device:
-      Cara Penggunaan / Direction of Use
-      Indikasi / Indication
-      Brosur / Brochure
-      Material Produk / Product Material
-      Kadaluwarsa / Expiry date
  1. Deskripsi dan fitur Alkes / Description and Fiture of medical device
  2. Tujuan Penggunaan / Intended Use
  3. Indikasi / Indication
  4. Petunjuk Penggunaan / Direction for use
  5. Material / Composition
  6. Proses Produksi / Manufacturing procedure or Flow chart
 Formulir C
  1. Karakteristik dan Spek Kinerja Teknis Alat / Characteristic and Specification of Finished Good
  2. Spek Bahan Baku / Specification of Raw Material
  3. Hasil Uji Analisis Alkes / COA of Finished product
Formulir D
  1. Contoh Penandaan / Leaflet
  2. Kode Produksi dan Arti / Production code and meaning
  3. Penandaan pada Alat / Labelling
  4. Manual Instruction (Inggris & Indonesia) *


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