Syarat Pembuatan Izin Edar AKL :
1. Akun OSS
2. IPAK (Izin Distribusi)
3. Letter of Authorization
4. Certificate of Free Sales
5. ISO 13485 & CE Certificate
6. Quality Qontrol Pass
7. Manual Instruction
8. Declaration of Conformity
9. Component (Elektromedik)
10. Production Process
11. IEC 60601-1 (Elektromedik)
12. Brochure / Catalogue
13. Production Code Description
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