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

2. Deskripsi dan fitur Alkes / Description and Fiture of medical device
3. Tujuan Penggunaan / Intended Use
4. Indikasi / Indication
5. Petunjuk Penggunaan / Direction for use
6. Material / Composition
7. 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) *