FDA Philippines · structured requirements

🇵🇭 Philippines medical device regulatory data

Explore the medical device requirements currently available for Philippines, 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

Type: Route Dependent
Description: CMDN/CMDR/CPR validity varies by authorization and transition; official materials show 1-, 3- and 5-year patterns rather than one universal term.

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

authorization.lapse

Expired authorization cannot support ordinary marketing; route-specific late treatment must be checked.

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

authorization.renewal

Renewal/revalidation is a separate application; current Class A portal guidance routes renewal separately from initial filing.

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: Ownership and inclusion/deletion/change of trader/importer/distributor are listed variation events.

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

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: Marketing Authorization Holder Or Registrant
Name: Philippine MAH/trader/importer/distributor
Required For Foreign: yes
Registration Relation: Local Licensed Entity Holds Authorization
Importer Relation: May Be Same
Distributor Relation: may_be_same; MAH may be manufacturer/trader/distributor
Combination: allowed

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: Ownership Or Trader Importer Distributor Variation
Fresh Registration: Usually No If Approved Variation
Minimum Handover: termination/deed of assignment
manufacturer agreement with new party
valid LTO
original authorization
labels
complaint/recall records
inventory
Notes: Variation and renewal should not be collapsed into one filing.