The LAR-first rule
The local partner holds the Establishment Licence (importer/distributor, 2–4 months, warehouse inspection) before any device registration starts.
Free field guide · PDF
Pakistan DRAP Medical Device Registration2026 Field Guide
The LAR-first rule, the abridged lane, and the 21-day reform target — with the conformity-assessment picture.
- Reform target
- 21 days
- Establishment licence
- 2–4 mo
- Registration validity
- 5 yrs
Sourced from DRAP 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 — DRAP guidance and verified 2026 publications.
Abridged vs. standard
Abridged pathway with US FDA / EU / Canada / TGA / PMDA approvals — standard review is long and may demand clinical trials.
The 21-day reform target
DRAP's 2026 reform target: 21-day registration — plus the $3B import market reality and the National Medical Device Policy 2026.
Sources & scope
- meddeviceguide.com, Pakistan DRAP registered medical devices teardown & 2025 ramp.
- imrozepakistan.com, SSF calls for local medical device manufacturing (2026).
- massdevice.com (Emergo Group), Pakistani medical device and IVD registration rules.
- ahwp.info, Medical Device Rules 2017 enforcement timeline context.
This guide is market-access intelligence, not regulatory or legal advice. DRAP reform timelines, fees, and review practice change — professional review is required before business use.
Market Access Strategy Session
Pakistan on your roadmap? Start with the full picture.
A Market Access Strategy Session maps your DRAP route — LAR and establishment licensing, pathway selection, and reform-target sequencing.
Professional review is required before business use.
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