The four-step DDF process
Classification → Submission → Evaluation → Approval at DDF, aligned to the ASEAN Medical Device Directive.
Free field guide · PDF
Cambodia Medical Device Registration2026 Field Guide
The four-step DDF process, the flat fee, and the local-filer rule — with the dossier practice you need.
- Flat registration fee
- $100
- Registration timeline
- 12–18 mo
- Certificate validity
- 3 yrs
Sourced from DDF guidance and verified 2026 publications.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — DDF guidance and verified 2026 publications.
The flat fee
400,000 KHR (~100 USD) flat for every class, a 12–18 month clock, and a 3-year certificate that renews by new filing.
The local-filer rule
The license holder may be foreign, but a local licensed pharmaceutical importer with a Cambodian pharmacist must file.
Sources & scope
- andamanmed.com, IVD Registration Services in Cambodia (Sep 2026).
- omcmedical.com, Cambodia Medical Device Registration.
- arqon.com, Medical Device Regulation in Cambodia.
This guide is market-access intelligence, not regulatory or legal advice. DDF timelines, guidance, and review practice change — professional review is required before business use.
Market Access Strategy Session
Cambodia on your roadmap? Start with the full picture.
A Market Access Strategy Session maps your DDF route — local-filer setup, dossier assembly, and quarterly approval-cycle planning.
Professional review is required before business use.
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