Approval validity & renewal by country

type: not verified · description: The current official service set confirms registration, amendment and cancellation, but an exact current product registration term was not verified in this round.

type: fixed term · description: 5 years

type: route dependent · description: EAEU common marketing authorization is indefinite; legacy/national transition records may follow separate rules.

years: 10 · startsFrom: official gazette publication

type: route dependent · description: Class I/II notification is generally indefinite; Class III/IV registration is valid 10 years.

Expired registration cannot support new lawful placement; use the current renewal/new registration rule.

Class III/IV renewal is filed from 12 to 6 months before expiry; notification devices remain subject to ongoing compliance.

type: indefinite with annual retention · description: A Class II IV Medical Device Licence is maintained through annual licence review/fees rather than a multi year expiry certificate; MDEL is a separate annual establishment clock.

Failure to complete required annual review/payment can cancel the licence.

Annual MDL and MDEL maintenance as applicable.

type: route dependent · description: Class I filing has no ordinary five year certificate; Class II/III registration certificate is valid 5 years.

Late/non compliant renewal conditions can require a new application or end marketing authorization.

Class II/III renewal is filed 6 months before expiry.

years: 10 · startsFrom: administrative act issuance

monthsBeforeExpiry: 3

type: fixed term · description: 10 years

Expired registration does not authorize continued new placement.

Renewal follows the required legal and technical procedure before expiry.

type: fixed term · description: 5 years

type: fixed term · description: Five year cycle under the current sanitary registration framework; verify product specific exceptions.

If not re registered in time, the product cannot be imported/manufactured/marketed and a new registration process is required.

type: not verified · description: Registration is required; exact current universal term was not confirmed from the 2026 official guideline.

type: fixed term voluntary listing · description: MDACS device listing is voluntary and valid 5 years.

Late renewal may not be processed and the device may be delisted.

LRP submits renewal at least 12 weeks and not more than 1 year before expiry.

type: indefinite with retention · description: Import/manufacture licences remain valid perpetually unless suspended/cancelled, subject to retention fee every 5 years.

Failure beyond the permitted period can result in deemed cancellation and need for a fresh licence.

Pay retention fee every 5 years; a late period up to 90 days may apply with fee.

Expired authorization generally requires a new application.

Apply from 6 months before expiry.

type: route dependent · description: AMAR approvals have explicit expiry dates and are renewed; duration can track the underlying reference approval and route rather than one universal term.

Expired approval cannot support ordinary continued marketing absent an official extension.

Renew before expiry with current foreign regulatory evidence and importer/manufacturer declarations.

type: route dependent · description: Product approval/certification is not generally a simple five year renewal; foreign manufacturer registration and QMS conformity have separate 5 year maintenance cycles.

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.

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

A dedicated renewal service applies to registrations.

type: fixed term · description: 5 years

After expiry, a new registration application is required.

type: fixed term · description: Initial registration is valid 5 years; the current first extension service states a 10 year extension output, which should be retained as a route specific current service rule.

File the applicable prórroga before expiry with current evidence.

type: fixed term · description: 5 years

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

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

type: fixed term · description: 5 years

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.

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

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

type: route dependent · description: EAEU common authorization is indefinite; current Russian national registration is generally maintained without periodic renewal, with exceptions/transitional certificates handled separately.

type: fixed term · description: MDMA is valid for up to 3 years.

Expired MDMA cannot support ordinary placement.

type: fixed term · description: Registration has a defined expiry/extension cycle; exact current term should be rechecked against implementing rules before publication.

Extension service exists; file before expiry.

type: indefinite with annual retention · description: Registered Class B/C/D devices remain on the Singapore Medical Device Register subject to annual retention and ongoing compliance.

Non retention or cancellation ends active registration/listing.

Pay annual retention; dealer licences have separate annual renewal.

type: establishment licence only or transitional · description: Current broad control is establishment licensing rather than a universal mature product registration certificate; establishment licences are valid 5 years.

After expiry, a new licence is required and trading must stop.

Apply for establishment licence renewal at least 90 days before expiry.

type: fixed term · description: 5 years for covered medical device permits/certifications/notifications, except stated exemptions.

Failure to renew causes the authorization to lapse.

Apply 270 180 days before expiry with safety/effectiveness and production/import history.

type: route dependent · description: No generic Swiss product licence expiry for ordinary CE conforming devices; conformity assessment certificate validity and legacy transitions apply separately.

type: fixed term · description: Medical device licence generally follows a 5 year term; QMS compliance letter is a separate 3 year clock.

Expired licence cannot support ordinary marketing and may require a new application.

Apply for licence extension within 6 months before expiry.

type: route dependent · description: Full registration is valid 5 years; notification is valid 3 years.

daysBeforeExpiry: 90 · direction: no earlier than

years: 5

type: fixed term · description: Medical device licences/detailed listing/listing authorizations renew for another 5 years.

After the permitted late period, renewal is unavailable and a new process is required.

Apply no more than 90 days before expiry.

type: fixed term · description: 5 years

Expired authorization cannot support ordinary import/marketing.

Renewal grants another 5 years; use the dedicated service while authorization is active/eligible.

type: route dependent · description: No generic UK product registration expiry; market access follows the accepted conformity route while MHRA registration is maintained and annual fees/review requirements are met.

Invalid conformity evidence or inactive/cancelled MHRA registration prevents lawful placement.

The old renewal transaction was removed; review data frequently and pay annual registration fees under the current scheme.

type: indefinite with annual establishment maintenance · description: 510(k), De Novo and PMA are not ordinary annually renewed product authorizations; establishments register and list annually and PMA supplements/annual reports apply as relevant.

Failure to maintain establishment registration/listing or required PMA obligations disrupts lawful marketing, but this is not a simple product certificate expiry.

Annual establishment registration/listing update; product specific continuing obligations.

type: indefinite with ongoing compliance · description: Medical device circulation numbers issued under the current framework are indefinite.