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ISAF · structured requirements

🇲🇴 Macau medical device regulatory data

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

3 facts1 dimensions2 official sourceslatest verification 2026-08-13

Approval validity & renewal

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

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Authorization duration

authorization.duration
Official document
Type

Route Dependent

Description

Under the regime effective 1 July 2026, Class IIb/III registration is valid 5 years; Class I/IIa are phased filings rather than registrations.

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

Expiry or lapse consequence

authorization.lapse
Official document

Unregistered/unfiled or invalidated devices cannot circulate after applicable transition deadlines.

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

Renewal or maintenance

authorization.renewal
Official document

A dedicated renewal service applies to registrations.

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

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