DRAP · structured requirements

🇵🇰 Pakistan medical device regulatory data

Explore the medical device requirements currently available for Pakistan, organized by topic and linked to official sources.

7 facts3 dimensions2 official sourceslatest verification 2026-08-13

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

authorization.duration

Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.

authorization.lapse

After the late period, the application is treated as fresh.

Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.

authorization.renewal

Apply before expiry; a late window up to 1 year may be available with monthly fee under the rules.

Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

change.available-outcomes

Outcomes: Prior Approval Amendment Or Variation
New Registration Or New Application
Description: Changed device may not be marketed until required MDB approval.

Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.

change.new-application-triggers

changes not approvable within the existing registration or after late-renewal period

Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

market-entry.local-role

Archetype: Licensed Importer As Applicant
Name: Pakistan licensed medical-device importer
Required For Foreign: yes
Registration Relation: Applies For Imported Device Registration After Establishment Licence
Importer Relation: same
Distributor Relation: May Be Same Or Downstream
Combination: Allowed Subject To Licence

Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.

market-entry.representative-change

Path Code: Prior Approval Change Or Fresh Application
Fresh Registration: Route Dependent
Minimum Handover: manufacturer authorization
establishment licence
registration file
import records
complaints/vigilance/recalls
label updates
Notes: No separate EU-style AR archetype was verified; model the importer/applicant explicitly.