Approval validity & renewal by country

AKBPM cancels a device registration from the National Register: (a) at the request of the certificate holder; (b) ex officio if the manufacturer, the manufacturer's representative or the wholesaler is found to have been registered in breach of the law; (c) by order of the minister if the device is found to present a risk to the health or safety of patients, users or other persons; cancellation is effected within 30 days.

The device registration certificate (classes II and III) is valid for 5 years from the date of issuance.

The homologation decision is renewable on request of the holder and/or operator, after commission opinion; the application with its dossier must be filed at the latest 90 days before the expiry date of the decision (renewal dossier in consolidated two part form per annexe III; ANPP may require the full five part dossier and may initiate quality control or performance expertise).

If the homologated device is not effectively placed on the market or exported within 18 months following notification of the homologation decision, ANPP reserves the right to withdraw the decision.

The device homologation decision is valid for five years from its date of signature (identical for export only decisions).

type: fixed term · description: 5 years; reválida (renewal) application must be filed within the last 90 days of validity

Class I and II reválida applications must be filed within the 90 days before registration expiry.

The import (conformity) certificate loses its force after customs clearance: it authorises a specific import transaction and is not a marketing authorisation. The certificate is issued after the applicant presents the receipt for payment of the state duty, and a paper copy is issued free of charge within at most 2 working days on application by the applicant or a person authorised by it.

ARTG inclusion of a kind of medical device may be cancelled under s 41GL(f) of the Act (or suspended under s 41GA(1)(b)) if the annual charge is not paid within 20 working days of it becoming payable; TGA issues invoices for all non ACE entries each July, so inclusion is retained by paying annual charges rather than by periodic renewal.

TGA Conformity Assessment certificates are issued for a finite period and expire: manufacturers must apply for recertification of a certificate that is about to expire, lodge new applications for substantial changes, and remain subject to TGA surveillance audits while certified.

EU certificates issued by notified bodies are valid for the period they indicate, which may not exceed five years. On application by the manufacturer the validity of the certificate may be extended for further periods, each not exceeding five years, based on a re assessment in accordance with the applicable conformity assessment procedures; any supplement follows the same rules.

A registration certificate issued for a medical device is valid for 5 years. An applicant may apply to the Ministry for re registration at least 7 (seven) working days before the certificate expires; the re registered certificate takes effect on the day following the day the previous certificate lapses.

Resolution No. (69) of 2024 replaced the first two paragraphs of Article (10) of Resolution No. (48) of 2020 so that, except for low risk home use devices, no person may market or advertise a medical device without prior authorisation and payment of the prescribed fees, and the marketing authorisation for devices meeting global quality and safety standards is valid for three years after full payment of the fees. The earlier text set a twelve month term or the expiry of the quality certificate, whichever was earlier.

Establishment licences are valid for 2 years from the date of grant and are renewable; the renewal application must be submitted not more than 90 days before expiry.

Drug (including device) registration remains valid for 5 years and is renewable; the renewal application must be submitted not more than 90 days before expiry; the Marketing Authorization Certificate remains valid as long as the registration is valid.

The national registration certificate is indefinite ('Регистрационное удостоверение является бессрочным'). Reregistration applies only where a certificate issued before 25 July 2022 expires; devices imported or produced while such a certificate was valid may still be sold/used until their shelf life or service life expiry.

EU certificates issued by notified bodies are valid for the period they indicate, which may not exceed five years. On application by the manufacturer the validity of the certificate may be extended for further periods, each not exceeding five years, based on a re assessment in accordance with the applicable conformity assessment procedures; any supplement follows the same rules.

statement: Reinscription follows the same procedure as inscription except for the requirements expressly indicated, and should be filed within the three months before expiry of the Registro Sanitario. A request presented before the five years are completed, and as a tolerance up to a limit of 30 working days after the expiry of the Registro Sanitario, may be treated as a reinscription, the registration remaining valid for manufacture, import, distribution and marketing. Reinscription requests presented up to 30 calendar days after expiry must pay the fee corresponding to an inscription. · article: Numeral 2.3.3(a) and numeral 3.1.7

statement: During the reinscription process the Registro Sanitario continues to be valid for manufacture, import, distribution, marketing and acquisition until the updated Registro Sanitario is issued, provided the application was filed within the window set by numeral 2.3.3(a) of the device manual. · article: Closing paragraph

statement: Within 30 working days from entry of the dossier to the Directorate of Medicines and Health Technology, the original Registro Sanitario certificate is delivered with a validity of 5 years, together with two legalised copies at no cost, which the regent, technical responsible or accredited representative must sign. · article: Numeral 3.1.5

The holder of an entry in the Register is obliged to renew, within 30 days, the validity of certificates and other documents that have an expiry date. A manufacturer or representative submitting a certificate that bears only an issue date must submit a new certificate to the Agency within five years of the date of issue. If the validity of expired documents is not renewed and they are not submitted to the Agency within the prescribed period, the Agency deletes the medical device from the Register by a conclusion.

By the Agency's certificate of entry the applicant acquires the right to place the medical device on the market until the expiry of the certificate. The period of validity of the certificate of entry in the Register of medical devices is five years from the date of issuance.

Registration carries an ongoing annual obligation: MRSA 2013 s.24(4) requires the person who applied for registration to submit information annually in the prescribed manner with a prescribed fee, and BoMRA's retention guideline defines retention as the annual process of maintaining a listed and/or registered medical device on the register by paying the applicable annual fee and submitting any additional product information the Authority prescribes.

A device registration is valid for five years: BoMRA's in force registration guideline (BOMRA/ER/MED/P04/G01 Iss 3.0, s. 4.10) provides that the registration of a medical device shall be valid for five (5) years unless suspended or revoked by BoMRA or terminated by the registrant, and s. 4.14 requires applications for renewal of registration to be made six (6) months before the expiry of the existing registration. The draft Medical Devices Regulations, 2026 (reg. 20) would place the same five year term and six month renewal window on a statutory footing, but the draft is unpublished and not in force.

Applications for renewal of a device registration must be made six months before the expiry of the existing registration, submitting all applicable renewal requirements. If the registration certificate is not renewed after the expiry date it becomes invalid and the marketing authorisation is terminated.

IVD registrations are likewise valid for 10 years counted from publication in the Diário Oficial da União.

If ANVISA has not decided the revalidation petition by the registration expiry date, the registration is automatically revalidated, regardless of a decision.

Registration revalidation must be requested between 12 months (maximum) and 6 months (minimum) before the registration expiry date.

Device registrations are valid for 10 years from the date of publication in the Diário Oficial da União (DOU) and may be successively revalidated for equal periods.

The only validity and renewal rules in Brunei health product law are for medicinal products: the registration period is as specified in the product licence and, where none is specified, the registration is valid until cancelled (s. 11(6) (8)); import, manufacturer's and wholesaler's licences are valid for one year and a clinical trial import licence for up to 3 years (s. 15(4) (5)); licences are non transferable (s. 15(6)). No validity period or renewal applies to a medical device because no device approval exists.

AITI Dealer Type Approval is valid from a minimum of one year up to five years from issuance, and a licence under the Radiation Protection Act remains in force for such period as may be specified in the licence unless earlier suspended or cancelled, with renewal on application to the Authority.

The BDA registration certificate (удостоверение за регистрация/промяна) is issued valid until a change in the device or other changes in the declared data occur — no fixed expiry date and no periodic renewal.

Under Article 7 of Prakas 4206, if a variation affects information printed on the visa registration certificate, a new certificate is issued counted from its own date of issue while retaining the original expiry date, and the original certificate must be returned with the application; variations that do not affect certificate particulars are filed with a copy of the certificate.

The DDF sample letter for renewal of validity of a device/reagent registration ('សំណើសុំបន្តសុពលភាពបញ្ជិកា…លើកទី…') carries a product table with an 'Old License No.' column and lists, in addition to the initial application attachments, the most recent device/reagent registration certificate.

Article 9 of Prakas 1258 fixes the validity of a medical/dental device visa registration certificate at three years counted from the date the certificate number is issued, and requires the company, six months before expiry, to complete and submit the renewal application to the Ministry of Health with the documents set out in Articles 5, 6 and 7.

A Class II IV Medical Device Licence has no fixed expiry: it is maintained through an annual confirmation/licence renewal submitted before November 1 each year, together with the annual right to sell fee.

If the annual confirmation is not filed the Minister may cancel the medical device licence; a licence holder who discontinues sale of the device must notify the Minister within 30 days and the licence is cancelled when the Minister is informed. For MDELs, failing to file the Annual Licence Review before April 1 means the licence is cancelled starting April 1 and licensable activities must stop.

Maintenance is annual on two separate clocks: MDLs are renewed by the annual confirmation before November 1 (s.43 MDR) with the right to sell fee; MDELs are maintained by the Annual Licence Review filed before April 1 each year (s.46.1 MDR) even when nothing has changed, with the MDEL fee payable on invoice.

The device registration authorization is valid for 3 years counted from notification (per Article 7 of the Código Sanitario), and is automatically and successively extended for equal periods unless expressly revoked — i.e., no renewal application is required.

The medical device registration certificate is valid for 5 years. Class I filing has no ordinary 5 year certificate.

Renewal (延续注册) must be applied for with the original registering authority at least 6 months before the certificate expires.

If the authority fails to decide on a timely renewal application within the statutory time limit, the renewal is deemed approved.

Holders must commercialize the product within 36 months from the administrative act (or code) granting the registro or permiso; failure results in automatic cancellation. On justified grounds the titular may notify INVIMA/competent authority within one month of the deadline, and the authority may set a new term once, by reasoned resolution.

type: fixed term · description: 10 years from issuance of the administrative act (Art. 31, Decreto 4725 de 2005)

If the registration or permit expires without a timely renewal request (or the request is abandoned/withdrawn or filed late), the product may not be imported into Colombia or manufactured; INVIMA gives interested parties up to 6 months to dispose of existing stock, after which it orders seizure (decomiso).

Renewal follows the same procedure as issuance for the technical and legal evaluations (quality control analysis and BPM compliance verification may apply); the registration is renewed under the same number followed by 'R' plus a consecutive digit.

years: 10 · startsFrom: administrative act issuance

monthsBeforeExpiry: 3 · lateFilingConsequence: processed as a new application

EMB sanitary registration is valid for five years, without prejudice to the Ministry's cancellation or modification powers under Ley N° 5395 (Ley General de Salud).

Decreto 43789 S establishes renewal of EMB registration by notification for classes 2, 3 and 4 (not available where post registration changes are pending in Regístrelo): the applicant files the form, a sworn declaration of no changes, payment receipt and (for imports) a free sale certificate authenticated and legalized by the Costa Rican consulate in the country of origin; resolution is granted expeditiously upon complete submission and the renewed registration is valid five years from approval; the fee equals the registration fee.

Renewal grants a period equal to the initial registration; before expiry the holder or legal representative must file via Regístrelo: renewal form, current legal representative power (if expired/absent), manufacturing contract (if third party manufacture and expired/absent), sworn declaration that product conditions have not changed, GMP certificate, valid operating permit (national products), free sale certificate (imported products), label (if not in file), radiation authorization where applicable, animal tissue biological safety certificate where applicable, and the Decreto 32780 fee.

The Autorisation de Commercialisation obtained through the conformity assessment is valid for a renewable period of five years. Renewal is a distinct, fee scheduled step: the schedule carries a renewal line at half the base registration fee for each class (25 000 / 125 000 / 250 000 / 500 000 / 1 250 000 CFA francs).

A CE certificate issued by a notified body under MDR/IVDR is valid for the period it indicates, which may not exceed five years; on application by the manufacturer the validity may be extended for further periods each not exceeding five years, based on a re assessment under the applicable conformity assessment procedures. Any supplement to a certificate remains valid as long as the certificate it supplements is valid.

Devices covered by a certificate issued under Directive 90/385/EEC or Directive 93/42/EEC that is valid by virtue of MDR Article 120(2) may still be placed on the market or put into service until 31 December 2027 for all Class III devices and for Class IIb implantable devices (except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors), and until 31 December 2028 for other Class IIb devices, Class IIa devices, and Class I devices placed on the market in sterile condition or with a measuring function. Devices whose Directive conformity assessment did not require a notified body, with a declaration of conformity drawn up before 26 May 2021 and requiring notified body involvement under the MDR, may be placed on the market until 31 December 2028.

Per Article 59 of the Reglamento, the registration of a device may be extended (prórroga) for a five year period from the expiry date of the first registration; the total validity of registration plus prórroga may not exceed ten years, after which a new registration application must be filed. E 84 16 (Resolución CECMED 48/2016, in force 27/07/2016) governs the renewal/modification process; during prórroga the manufacturer must demonstrate continued compliance with the essential requirements and effectiveness in use during the approved validity period.

The prórroga of the Registro Sanitario must be requested by the manufacturer or its representing suministrador during the 90 days before the registration expiry date. If not filed, cancellation takes effect from the expiry date.

The Registro Sanitario is valid for the period stated in the Registration Certificate, not exceeding five years. At the manufacturer's request the registration may be extended (prórroga) for periods not exceeding five years, subject to new evaluation under the renewal regulation (E 84 16). If by the expiry date the manufacturer has not filed the prórroga application, CECMED proceeds to cancel the registration.

Cyprus issues no national approval with a validity period. The certificate that governs a device's conformity — issued by a notified body under Regulation (EU) 2017/745 — is valid for the period it indicates, which may not exceed five years, and on application by the manufacturer its validity may be extended for further periods each not exceeding five years, based on a re assessment under the applicable conformity assessment procedure. The parallel rule for in vitro diagnostic medical devices is Article 51(2) of Regulation (EU) 2017/746.

The extended MDR transitional periods run only for devices covered by a certificate issued under Directive 90/385/EEC or Directive 93/42/EEC, or whose pre 26 May 2021 declaration of conformity did not require a notified body. As at 15 September 2026 the extended dates are 31 December 2027 for all class III devices and for class IIb implantable devices other than certain well established technologies, and 31 December 2028 for other class IIb devices, class IIa devices and class I devices placed on the market sterile or with a measuring function. A US FDA, Japan PMDA, Korea MFDS or China NMPA approval confers no transitional benefit, because it is not a Directive certificate.

Notified activity data in ISZP are valid for 1 year: the notified person must confirm the correctness of its data within 1 year of notification or of the last confirmation; SÚKL sends a reminder 30 days before the deadline via ISZP. If not confirmed, the data are invalidated and no longer published; on request they can be restored within 6 months of invalidation (restoration fee 1 500 Kč); invalidated data are deleted 3 years after invalidation.

The sponsor must keep the MDR Annex XV documentation (Annex XIV for IVD performance studies) available for the Danish Medicines Agency for at least 10 years after the clinical investigation or performance study ended — or, if the device is subsequently placed on the market, at least 10 years after the last device was placed on the market; for implantable devices the information must be kept for at least 15 years.

The Danish national distributor/specialty retailer registration does not expire, but the annual supervision fee must be paid through and including the calendar year in which the company ceases its registration with the Danish Medicines Agency (unless cessation is notified within the first 3 months of the year).

statement: Under the Ley General de Salud the authorisation for medicines and other sanitary products is temporary; once its term expires it must be revalidated in the form and within the period set by regulation, and the holder must notify its intention to keep the products on the market so that the authorisation does not lapse. · sourceApproval: none · targetJurisdictionId: dominican republic · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: market oversight · localApplicationRequired: Yes · targetDecisionRetained: Yes

statement: Renewal of the sanitary registration of foods, medicines, sanitary products, cosmetics and hygiene products is automatic provided the renewal service fee has been paid and the registration to be renewed is in force. The holder must file the renewal application within the three months before expiry; if the expiry date passes without an application the registration is cancelled with no right to an extension. Applications are filed on the corresponding form with proof of payment, a current GMP certificate where applicable and a current distributor certificate where applicable. · sourceApproval: none · targetJurisdictionId: dominican republic · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: market oversight · localApplicationRequired: Yes · targetDecisionRetained: Yes

The sanitary registration certificate for medical devices is valid for 5 years from grant and renewable for equal periods; the Ley Orgánica de Salud sets a statutory minimum of five years for sanitary registrations/notifications, and the 2026 norm (Art. 17) states the same five year term.

If re registration is not requested within the established window and the registration expires, the product may not be imported, manufactured or marketed in Ecuador and a new inscription process must be started.

Re registration is automatic (no further requirements beyond the request attesting the facts) where the device had no changes in intended use, quality, safety or efficacy during the validity period, was not subject to sanitary alerts or ARCSA suspension, and the request is filed at least 90 days before expiry; otherwise a QMS certificate, a sworn declaration (after alerts/suspension) and documents supporting unapproved modifications must be filed.

Re registration (reinscripción) requests must be filed at least ninety (90) days before the registration expiry date and not more than six (6) months in advance; requests are filed by the holder through the VUE.

After completing the registration file and paying fees, a registration license (registration report) is issued for the medical device valid for 10 years.

Re registration is every 10 years; initial acceptance of the re registration request must be within the first 3 months of the last year of the license validity. The applicant may complete re registration within one year after expiry and trading is permitted during that year; otherwise the request is cancelled, the inspection administration is notified, and renewal requires a new request and fee repayment.

On application, Ravimiamet issues a free sale certificate to a manufacturer or authorised representative registered in Estonia for the export of a medical device. The certificate attests that the registered place of business is in Estonia and that the CE marked device may be marketed in the European Union. It is drawn up in English, issued in one copy on paper, and is valid for two years from issue unless the device's conformity certificate expires sooner.

Devices holding a valid Directive 90/385/EEC or 93/42/EEC certificate may continue to be placed on the market until 31 December 2027 for class III devices and class IIb implantable devices (with listed exceptions), and until 31 December 2028 for other class IIb devices, class IIa devices and class I devices placed on the market sterile or with a measuring function. In Estonia these devices are also subject to the MDR requirements on post market surveillance, market surveillance, vigilance and registration of economic operators and devices.

Marketing authorisations granted by EFDA are valid for five years and must be renewed every five years. The option to apply for re registration opens when three months remain before the certificate expires, and applicants are advised to file at least two months before expiry because re registration assessment may take time. A re registration file requires an application letter, a valid QMS conformance certificate, a valid original free sale or marketing authorisation certificate, a valid manufacturing licence, a declaration of conformity, a GMP certificate if applicable, a letter confirming no change or a summary of changes since the last EFDA approval, and device vigilance and post market surveillance reports for sterile devices, devices with a measuring function and all Class III/C and above devices. If the certificate has already expired, the applicant must file a new registration application with the full requirements and assessment time of a new device.

directive 98 79 EC certificates: Certificates issued from 25 May 2017 still valid on 26 May 2022 remain valid until 31 December 2027 · legacy class D: May be placed on the market until 31 December 2027 · legacy class C: Until 31 December 2028 · legacy class B and sterile class A: Until 31 December 2029

class III and class IIb implantable except listed: May be placed on the market/put into service until 31 December 2027 · other class IIb class IIa class I sterile or measuring: Until 31 December 2028 · legacy class I needing notified body under MDR: Until 31 December 2028

Notified body certificates issued under Annexes IX, X and XI are valid for the period they indicate, which must not exceed five years; on application by the manufacturer, validity may be extended for further periods of up to five years each, based on a re assessment in accordance with the applicable conformity assessment procedures; supplements remain valid as long as the supplemented certificate is valid (Art. 56(2) MDR).

National operator/device registrations have no expiry date: Fimea stores the notified data in its national device register (laiterekisteri) and keeps them for as long as supervision of the devices and operators requires; annual supervision fee liability continues each year until termination of the activity is reported to Fimea or otherwise established (51 § 1 mom).

EU certificates issued by notified bodies are valid for the period they indicate, which may not exceed five years. On application by the manufacturer the validity of the certificate may be extended for further periods, each not exceeding five years, based on a re assessment in accordance with the applicable conformity assessment procedures; any supplement follows the same rules.

Circulation of a registered product on Georgian territory is permissible for 5 years after registration, and after expiry of the registration validity period until expiry of the shelf life of the product. For re registration, registration documents must be submitted not later than two months before expiry of the registration validity period; otherwise the product is registered under the primary registration regime. Where the product was registered through the recognition regime, the Georgian authorisation period follows the foreign authorisation period but is not more than 5 years.

EU certificates issued by notified bodies are valid for the period they indicate, which may not exceed five years. On application by the manufacturer the validity of the certificate may be extended for further periods, each not exceeding five years, based on a re assessment in accordance with the applicable conformity assessment procedures; any supplement follows the same rules.

Applications for renewal of device registration must be made at least 3 months before expiry of the existing registration, with a completed renewal form, samples per the FDA sample schedule, and the fee.

Under Act 851, a licence or permit (including importer/exporter licences) may be renewed for a period of not more than five years, and registration of premises likewise for not more than five years.

On approval, the Authority allocates a registration number to the medical device for a period of not more than five years and issues a certificate of registration.

The EOF national register operates with renewal (ανανέωση/επαναεγγραφή) applications: no new fee (παράβολο) is due if less than five years (πενταετία) have elapsed since the last registration renewal — i.e. a new fee is expected when renewal occurs at 5 year or longer intervals. Renewal, new and supplementary applications otherwise follow the same procedure and fee schedule.

A device inscription is valid for five years from the date of grant. Renewal must be applied for before expiry. If the renewal documentation is not filed before the expiry date of the initial authorisation, the DRCPFA treats the inscription as cancelled, and the applicant must file a new inscription meeting the full Art. 5 requirements. IVD inscriptions carry the same five year term.

An approval or conditional approval for listing a device is valid for five (5) years.

Renewal applications are not accepted outside the 12 weeks to 1 year window, and if the listing has expired the applicant must submit a NEW application (not a renewal); unnotified or unapproved changes also invalidate the listing immediately.

The LRP must submit the renewal application between 12 weeks and 1 year (inclusive) before expiry of the five year validity; no renewal application is accepted outside this window.

When registered actor data change and the change is reported, the previously issued official certificate (hatósági bizonyítvány) of the EUDAMED Actor registration loses its validity.

A deviation permit (eltérési engedély) from conformity assessment procedures is granted for a defined period only and is valid only on the territory of one country (Hungary).

The register that a distributor must keep current in Iceland is the distributor register kept by Lyfjastofnun under Article 28(3) of Act No. 132/2020, and Article 39(5) of the Act makes distributor registration a head of charge. Section 2 of gjaldskrá No. 1529/2025 (17 December 2025) prices it in two separate lines: 'Skráningargjald' (registration charge) ISK 53,400 and 'Viðhaldsskráning' (maintenance registration) ISK 26,700, under the heading 'Gjald fyrir skráningu í þessa skrá Lyfjastofnunar og viðhald hennar'. The schedule fixes no interval for the maintenance charge and no expiry date for the registration itself. Lyfjastofnun's guidance adds that a distributor registers with the agency as a supervised operator, that the agency invoices the distributor according to the fee schedule, and that the distributor need not wait for the invoice to begin distributing devices — so registration is a precondition of activity, not a time limited permit.

Iceland grants no national approval for a medical device or IVD and Lyfjastofnun keeps no register of individual devices, so there is no Icelandic registration, licence or authorisation with a validity period to renew and no renewing device fee. What carries a validity period is the Union documentation: MDR (EU) 2017/745 and IVDR (EU) 2017/746 have legal force in Iceland under Article 2 of Act No. 132/2020, and Article 56(2) of the MDR (Article 51(2) of the IVDR in identical terms) provides that the certificates issued by notified bodies are valid for the period they indicate, which shall not exceed five years, and that on application by the manufacturer the validity of the certificate may be extended for further periods, each not exceeding five years, based on a re assessment in accordance with the applicable conformity assessment procedures. Operator registration is a separate, non time limited act: manufacturers, authorised representatives and importers register in the electronic system under Chapter III of the Regulations and Lyfjastofnun confirms the registration and issues a unique registration number (Art. 28(1) (2) of the Act); distributors register with Lyfjastofnun under rules the agency sets (Art. 28(3)).

Manufacturing licences (Forms MD 5/MD 6/MD 9/MD 10) remain valid in perpetuity subject to payment of the licence retention fee before completion of every five year period, unless suspended or cancelled; import licences (MD 15) are likewise perpetual unless cancelled or surrendered, with retention fee per overseas site and per licensed device every five years.

If the retention fee is not paid within the permitted late fee period, the licence is deemed to have been cancelled (and a fresh licence is then required).

Retention fee is payable every five years. The late payment grace differs by authorisation type: import licences deposit permitted up to 90 days after the due date with late fee of 2% per mensem (rule 37 proviso); manufacturing licences up to 180 days with late fee of 2% per month (rule 29(2)); Form MD 42 sale registration up to six months with late fee of 2% per month (rule 87C).

If the extension application is filed after the validity has expired, it follows the rules for a new izin edar application; once validity has expired without an approved extension, the device is prohibited from circulation. Products whose izin edar has expired and was not extended must be withdrawn from distribution (recall ground) and are subject to destruction.

Under the electronic integrated licensing regime (PMK 26/2018, in force 12 July 2018), the business licence (Izin Usaha) is valid for as long as the business operator runs its business, while commercial/operational licences are valid 5 years and extendable; branch device distribution licences follow the head office certificate.

The authorization holder must file the extension application at the earliest 9 months before the validity expires (paling cepat 9 bulan sebelum masa berlaku habis). Device izin edar is explicitly excluded from the general 6 months before expiry OSS extension rule of PMK 26/2018 Pasal 87(1) (exemption letter a). Before applying, the holder must have submitted electronic production/distribution reports (e Report); a renewal cannot be processed if reporting was nil for the 2 years preceding expiry.

The device/PKRT izin edar is valid for at most 5 years; where held through a sole/exclusive agency appointment the validity follows the appointment (which must run at least 2 and at most 5 years; if unlimited or over 5 years, the izin edar runs 5 years from the appointment); OEM product izin edar is valid at most 3 years. Validity may be extended if requirements are met.

IRC codes have limited validity and lapse with the underlying authorization: an expired IRC is rejected in the comprehensive code system, expiry of the product's پروانه ساخت ends its IRC, and IRCs of companies that fail to file amendments (اصلاحیه) are expired — reinstated only after filing the amendment and paying the goods registration and source registration fees (هزینه ثبت کالا و ثبت منبع).

The پروانه ساخت is issued for a definite period and is renewed after review of continued production conditions; renewal assessment covers production statistics, complaint and quality problem records and their resolution, discharge of commitments taken at initial issuance or last renewal, validity of the mandatory standard certificate for covered products, and closure of non conformities found in surveillance assessments (ارزیابی‌های مراقبتی).

National device registration carries an annual maintenance fee for all registered economic operators (whether registered via EUDAMED or directly with HPRA), invoiced in quarter 2 of each year; amounts vary by role and organisation size.

Correction with concrete values: a device is registered in the AMAR register for a period not exceeding five years; implants are registered for up to two years; devices registered or permitted for marketing in a recognized state are registered until the expiry of that state's registration/permit, provided the Israeli registration period does not exceed 5 years from the Israeli registration date.

The renewal application must be filed during the 4 months before registration expiry (earlier filing is possible with valid regulatory approvals per the renewal procedure). If a current CE certificate is not yet available at filing, a temporary register registration is set with validity of 6 additional months from the previous registration's expiry. Under the law (sec. 8), a timely filed application deems the registration extended until the Director General's decision.

Administrative extension ended 31.12.2024 covering certificates expiring 1.12.2022 30.12.2024 (due to EU extensions): where a renewal application was filed in Caspit with a submission date before 28.2.2025, the register registration is extended until 30.6.2025 unless cancelled or refused. Excludes Class I devices that must be registered in the declaration track; applies to register certificates only, not import approvals; not applicable where a change procedure applies. Fast track renewals received an updated certificate within 10 working days.

Distributors registered in the national database must confirm the accuracy of the data communicated to the Ministry of Health within one year of first conferring the information, and subsequently every two years.

Product approvals (承認) and certifications (認証) have no statutory expiry under the PMD Act; the recurring 5 year obligations are the MAH license (Order Art. 36), manufacturer registration (Order Art. 37 7), foreign manufacturer registration (Order Art. 37 13), and QMS conformity survey interval (Order Arts. 37 21/39).

Foreign manufacturer registration (and likewise domestic manufacturer registration, Order Art. 37 7) runs on a 5 year validity cycle; QMS survey periods under the RCAB route are likewise 5 years (Order Art. 39).

Registered medical supplies, sterilants and disinfectants are subject to renewal of registration (تجديد التسجيل); renewal applications are handled by the Registration Section of the Medical Devices and Supplies Directorate.

For medical devices an indefinite (бессрочное) registration certificate is issued, per para 6 of the EAEU Agreement on common principles of circulation of medical devices; the EAEU certificate likewise is issued indefinitely and acts on the territory of one or more member states.

A certificate of registration is valid for 5 years from the date of issue (rule 10(1), L.N. 100 of 2022; also section 2.12 of the registration guideline). In an emergency situation or in the public interest, PPB can at its discretion issue a certificate of registration valid for 2 years.

Renewal of registration is applied for using Form 4 (First Schedule) and must comply with the prescribed guideline for re registration and renewal; if a renewal application is filed before expiry, the certificate remains in force until the Board makes a decision on the application.

All medical devices and IVDs must be annually retained in the PPB database to maintain market authorization status in Kenya; the retention procedure should be done three months before the end of the year, submission opens 60 days before the retention due date, and an annual retention fee is payable via the PPB online portal. Failure to pay may lead to suspension and cancellation of the registration.

statement: The agency examines the applications of manufacturers, packers and distributors and enters the information in the LATMED database within 10 days of receipt. If the persons registered under paragraphs 4, 28 and 29 do not cover the agency's costs for the vigilance system within the deadline set by the agency, the agency removes the information about that person from the LATMED database. · sourceApproval: · targetJurisdictionId: · edgeType: · marketAccessStrength: · regulatoryLayer: · localApplicationRequired: No · targetDecisionRetained: Yes

statement: Certificates issued by notified bodies under Annexes IX, X and XI of Regulation (EU) 2017/745 are valid for the period they indicate, which must not exceed five years. On application by the manufacturer the validity may be extended for further periods, each not exceeding five years, on the basis of a re assessment under the applicable conformity assessment procedures. · sourceApproval: · targetJurisdictionId: · edgeType: · marketAccessStrength: · regulatoryLayer: · localApplicationRequired: No · targetDecisionRetained: No

The Ministry of Public Health issues the registration certificate on the basis of the opinion of the health technology unit; it is valid for five years and renewable on request of the beneficiary. Renewal dossiers are processed alongside registration, modification and withdrawal dossiers by the health technology unit.

EU certificates issued by notified bodies are valid for the period they indicate, which may not exceed five years. On application by the manufacturer the validity of the certificate may be extended for further periods, each not exceeding five years, based on a re assessment in accordance with the applicable conformity assessment procedures; any supplement follows the same rules.

A free sale certificate is valid for as long as the documents proving the device's conformity with Regulation (EU) 2017/745 or the IVD rules are valid, or is valid indefinitely if the validity period of the conformity documents is not specified; the issue/refusal decision is notified in writing within 20 working days (Art. 59 3(4)).

VASPVT cancels the validity of a device registration where: the registered person requests it; the registered legal person is liquidated or the natural person deceased; or other grounds listed in Art. 59 1(12) apply.

VASPVT suspends the validity of a device registration for a period of 90 days from adoption of the decision, on the grounds listed in Art. 59 1(8) (e.g. the registered person's request, or no confirmation of ongoing market subject status within 90 days of a supervision query).

It is prohibited to place medical devices on the market during the period of suspension of their registration.

EU certificates issued by notified bodies are valid for the period they indicate, which may not exceed five years. On application by the manufacturer the validity of the certificate may be extended for further periods, each not exceeding five years, based on a re assessment in accordance with the applicable conformity assessment procedures; any supplement follows the same rules.

Medical device registration is valid for 5 years and renewable for equal periods.

If the holder does not apply for renewal, or renewal is refused, the registration lapses at the end of its validity period. ISAF may suspend a registration for non compliance, and the holder must correct the causing irregularities within an ISAF specified period.

Registration renewal must be applied for between 180 and 90 days before expiry; the renewal dossier is a compliance declaration (continued legitimacy, continued conformity, unchanged approved label/IFU), the overseas marketing authorization document (except designated regions), and an adverse event monitoring report.

On cancellation of a registration the Authority notifies the registration holder in writing, who may submit a written show cause within ninety days from receipt of the notification.

A registered medical device is kept in the Register for five years from the date of registration unless the registration is cancelled earlier; fees are on a per application basis for the 5 year validity period.

The re registration function in MeDC@St 2.0+ opens exactly one year before the current registration certificate expires; the system automatically deactivates certificates upon expiry and does not allow any re registration submission after expiry (including unsubmitted drafts), after which a new registration application subject to the full conformity assessment process is required.

The substantive term of a device's approval is the CE certificate: a notified body certificate is valid for the period it indicates, which may not exceed five years, and may be extended for further periods of up to five years each on re assessment. Directive era certificates are governed by the transitional regime as amended by Regulation (EU) 2023/607: certificates issued under Directive 90/385/EEC or 93/42/EEC from 25 May 2017 that were still valid on 26 May 2021 remain valid until 31 December 2027 for class III devices and class IIb implantable devices, and until 31 December 2028 for other class IIb devices, class IIa devices and class I devices placed on the market sterile or with a measuring function. As at 15 September 2026 the extended dates are still in the future and no further extension has been adopted.

The Maltese national registrations do not lapse on a fixed term but renew annually against a fee: the distributor/importer organisation registration, the Medical Device Registered Person registration, and the device notification are each renewable annually. The annual invoice for organisation registration, MDRP and notified body registrations is issued pro rata to December of the year of approval and then annually for January to December; the device notification annual fee is invoiced for the product year, running from the month of approval. Annual fees are payable in full with no pro rata adjustment on withdrawal, and the operator must notify the Authority before the year end to avoid being invoiced for the following year.

type: fixed term · description: Initial sanitary registration is valid 5 years and may be extended (prórroga) upon request for 10 year periods per LGS Art. 376 (paragraph introduced by the reforms of DOF 10 05 2023, current text DOF 15 01 2026); the RIS separately requires later prórroga filings every five years (Art. 190 Bis 7, DOF 31 05 2021).

Renewal is by prórroga filed 150 natural days before expiry (first prórroga; later prórrogas every five years, same 150 day lead time). The acknowledgment receipt for later prórroga applications itself extends the registration, keeping the same alphanumeric key. If the application is not filed within the window, the registration loses validity and a NEW registration must be requested.

The registration procedure applies uniformly whether the device is registered for the first time or re filed following the expiry of an earlier registration; AMDM does not operate a distinct administrative "re registration" procedure. On expiry of the validity period of an existing registration the applicant files a new application, indicating the device's previous registration number to ensure traceability in the RSDM. The same rule applies to a device whose identification number has been deleted from the register. Where non conformities are found between the information entered in the RSDM and the documentation filed at registration, consisting of omissions or spelling or transcription errors, rectification is made exclusively on the basis of the documents that underlay the original registration.

Registration in the RSDM is valid for 5 years from the date it is effected. For the non CE route the registration is valid for a period of 5 years from the date of issue of the Order, on condition that no incidents occur during the registration period. The registration certificate for a non CE device is the Agency's registration order.

Laboratory diagnostic devices are registered, extended and certified for a period of five years. The registrant must submit a request to extend the period two months before the registration's validity expires, together with the complete registration documents and a statement of the quantity of stock remaining on the market. A device differing from the registered or listed model is treated as invalid. Renewal documents include the post market surveillance report.

statement: The registration decision's validity period cannot be longer than 60 days after the expiry of the conformity document. For Class I devices (other than Class Is and Class Im) and for in vitro diagnostic "other" devices marketed on the manufacturer's own declaration of conformity, the registration decision is issued for five years. A device for which no extension application has been filed may remain on the market at most 90 days after the registration decision expires, and during that period import of the device is prohibited. · validityRule: ≤ 60 days beyond the conformity document; 5 years for Class I / IVD other · renewalRequired: Yes

The device registration certificate is valid for a renewable period of five years, under conditions fixed by order of the Minister of Health. For used or refurbished devices, validity is limited to the remaining service life of the device. Where the certificate is updated after notification of changes to its particulars or to the dossier, or where the registration holder changes, it is valid only for the remaining term of the registration in progress.

A renewal application must carry, for all risk classes and all devices, administrative items (application in triplicate, copy of the fee receipt, fiche signalétique in triplicate with an electronic copy, copy of the previous registration certificate, and a sworn declaration by the registration holder that the product has undergone no change — with any change stated and justified; plus, for imported and semi finished imported devices, the manufacturer's or agent's attestation evidencing the link to the applicant) and technical items, of which the first is a materiovigilance review covering the last five years issued by the manufacturing establishment, together with the draft labelling and, where applicable, the draft instructions for use.

Medical device import registration certificates are subject to validity extension (renewal, သက်တမ်းတိုး); DFDA publishes half yearly lists of renewed certificates (e.g. July December 2025 list published 2 February 2026).

EU certificates issued by notified bodies are valid for the period they indicate, which may not exceed five years. On application by the manufacturer the validity of the certificate may be extended for further periods, each not exceeding five years, based on a re assessment in accordance with the applicable conformity assessment procedures; any supplement follows the same rules.

WAND entries carry no expiry date: the Medicines (Database of Medical Devices) Regulations 2003 (regs 1 15) contain no renewal, re notification or retention event; the only continuing duty is to correct information within 10 working days under reg 8, and Medsafe confirms there are no on going fees.

A successful device registration is issued a Certificate of Registration with a validity period of five (5) years; the certificate should be renewed upon expiration, and product licenses are renewed every five years.

A renewal application can be initiated six (6) months before the current registration certificate expires; each device, IVD and related product requires its own renewal application.

Any product with an expired registration license is considered an unregistered product; a late renewal of registration license/listing certificate carries an additional charge.

Renewal of a device registration must be applied for at the latest 90 days before the registration expires. The renewal documentation consists of the updated administrative data together with the manufacturer's declaration of conformity, the EC certificate, the EN ISO 13485 certificate, the free sale certificate and the insurance policy.

The registration of a device that holds an EC certificate is valid for as long as the EC certificate or the manufacturer's EC declaration of conformity is valid. For devices without an EC certificate the registration is time limited by class: three years for class I, class II a and IVDs including self testing, two years for class II b and List B IVDs, and one year for class III, active implantable devices and List A IVDs.

EU certificates issued by notified bodies are valid for the period they indicate, which may not exceed five years. On application by the manufacturer the validity of the certificate may be extended for further periods, each not exceeding five years, based on a re assessment in accordance with the applicable conformity assessment procedures; any supplement follows the same rules.

A 'Re registration of Medical Device' service exists (60 working days, same class based fees 100/200, commercial agency certificate required) to re register a device; the registration certificate validity period for devices is not stated in GD3/GD5 or the service pages.

The manufacturer registration fee is posted as 500 (non local manufacturer, five years) and 1,500 (local manufacturer, 3 years) on the registration service page, indicating the registration periods; a re registration service exists with the same fees.

Certificates of enlistment or registration are valid for five years from the date of issue unless earlier suspended or cancelled; the condition is printed on the Form 8 certificate format.

Under rule 16(5), a renewal application made after expiry but within one year attracts an additional fee equal to the applicable renewal fee for each month; after one year the enlistment or registration ceases to exist and the application is treated as a fresh application for grant of enlistment or registration.

Under rule 16(1), an application for renewal of a device's enlistment or registration, for local manufacture or import, must be made sixty days before expiry on Form 6 or Form 6A, Form 7 or Form 7A, accompanied by the application fee specified in rule 63.

Pending draft decree: Certificado de Registro Sanitario valid five years from issuance, renewable for five years on application up to 120 working days before expiry (Arts. 62 63); class A inscription certificate five years (Art. 59); Licencia de Operación two years, renewal 60 working days before expiry (Arts. 28 29); Certificado de Criterio Técnico five years (Art. 161). If DNDM causes renewal delay, an extension document is issued (Art. 147).

Renewal of sanitary registration certificates and of class I notifications is processed through simplified automatic renewal procedures; the holder files a BPF/GMP document issued by the competent authority or an ISO 13485 / CE / UL / FDA / TUV / MDSAP or equivalent certificate, together with a sworn declaration about modifications.

The validity period of both the Notificación Sanitaria Obligatoria and the Certificado de Registro Sanitario for medical devices is ten years, and they may be renewed successively for periods of equal duration.

The sanitary registration of an in vitro diagnostic product is valid for five years from issue and may be renewed for an equal period.

The product holder must file the renewal application within the 120 business days preceding the expiry date; otherwise the procedure is refused and the applicant must start a new product registration procedure.

The Registro Sanitario of devices within the Reglamento's scope is valid for five (5) years from the date of grant and is renewable ('El registro sanitario es temporal y renovable cada cinco años', Ley 29459 Art. 8); TUPA procedures likewise state authorization for 'cinco (05) años contados desde la fecha de su otorgamiento'.

The reinscripción application may be submitted from one year before expiry of the Registro Sanitario (Reglamento Art. 7; Ley 29459 Art. 11 likewise addresses timely reinscripción).

CMDN issued for Class B, C and D medical devices under FC 2021 002 are valid for two (2) years; the company must apply for a CMDR three (3) months prior to CMDN expiration.

CMDN and CMDR are valid for five (5) years and renewed every five (5) years after initial approval (AO 2018 0002 Sec. V(4)); 2025 Citizen's Charter confirms 5 year validity for CMDN initial, CMDR Class B initial and renewals. Exception: transition CMDNs for Class B/C/D under FC 2021 002 were valid two (2) years.

Renewal of CMDR/CMDN is accepted within ninety (90) calendar days prior to the expiry date; late filing incurs the corresponding penalty; a renewal application filed more than one hundred twenty (120) calendar days after expiration is not accepted and is treated as an initial application, and distribution and sale must automatically stop until the new certificate is approved.

Renewal and variation are separate application types from initial filings: under FC 2025 007 the Circular covers only initial CMDN applications, with renewal and variation submitted to the FDAC email channel; the 2025 Citizen's Charter defines separate renewal and variation services with their own fees and timelines.

EU certificates issued by notified bodies are valid for the period they indicate, which may not exceed five years. On application by the manufacturer the validity of the certificate may be extended for further periods, each not exceeding five years, based on a re assessment in accordance with the applicable conformity assessment procedures; any supplement follows the same rules.

Notified bodies must apply to INFARMED for revaluation of their designation at least one year before the end of each five year period counted from certification or recertification.

Technical documentation must be kept for 10 years after the start of use of the device and remain available for inspection; for implantable devices the period is 15 years.

Custom made registration certificates issued under the old Ordin 1009/2016 regime remain valid for 24 months from publication of the EU notice that EUDAMED has reached full functionality (MDR art. 34(3)).

The renewed aviz de funcționare is issued on the last day of validity of the permit held (or the last working day before it, if that day is not a working day).

National registration certificates (RU) are issued for an unlimited term with no periodic renewal; an RU for a series (batch) of a device under Government Decree No. 430 of 03.04.2020 is issued with validity limited to 01.01.2028, and the series/batch procedure itself is limited to 01.01.2028.

Holders of deficit list RUs issued under Government Decree No. 552 of 01.04.2022 must undergo re registration within a period not exceeding 150 working days to obtain an unlimited term registration certificate.

A certificate of full registration is valid for five years from issuance and may thereafter be renewed, subject to payment of prescribed annual retention fees. A certificate of notification is valid for three years. A certificate of conditional registration is valid for the period specified in the certificate, which may not exceed three years. Retention on the register is annual: an application for retention must be submitted one month before the due date, and the device is removed from the register if the application and fee are not effected. An application for renewal must be made at least 90 calendar days before expiry, with a grace period extending to 90 days after the expiry date; failure to renew within the grace period means the application is treated as new.

The MDMA certificate is valid for a term of up to three (3) years from its date of issue.

The MDMA certificate must be renewed before its expiration date, with updated documents submitted through the electronic system; a renewal request can be submitted from 90 days before the expiry date. An expired MDMA cannot support ordinary placement on the market or import clearance.

The device marketing authorisation for classes B, C and D is valid for five years, renewable. A renewal application for a device marketing authorisation must be filed 120 days before its expiry date at the ARP. Separately, an establishment agreement is granted for five years, renewable, and its holder must submit a complete renewal application six months before the agreement expires. The two clocks differ and run on different instruments.

A registration decision is issued for a validity period ending 60 days after the expiry date of the certificate of conformity. For Class I devices (other than Is and Im classes; bylaw also excludes Ir) and other in vitro diagnostic devices (IVD class A) placed on the market on the manufacturer's Declaration of Conformity, the registration decision is granted for five years from issuance. Devices may remain on the market at most 90 days after the registration decision expires; import is not possible for a device whose registration expired without a timely renewal request.

The manufacturer or authorised representative must file the renewal request at least 30 days before expiry of the registration decision; ALIMS decides within 15 days based on the valid conformity document and prescribed documentation. Renewal may include amendments at the applicant's request. If no renewal request is filed, ALIMS removes the device from the Register without a removal decision; the AR whose mandate ended must file removal from the Register of Manufacturers without delay. The device must be placed on the market within 12 months of the renewal decision.

Device registration remains in force indefinitely so long as the registrant continues to pay the prescribed annual retention fee within the prescribed time and the registration is not suspended or cancelled under s 37(1).

Registration is cancelled if the retention fee is not paid within the prescribed time, which is 60 days after the anniversary of the date of registration (reg 26A, for the purposes of s 37(2)).

Annual retention fees: Class B S$39, Class C S$67, Class D S$134 (including Class D with registrable drug), payable before the retention deadline; dealer's licences are renewed annually (importer/wholesaler/manufacturer S$1,110; amendment S$168).

A distributor registration with ŠÚKL is valid for 5 years; after expiry the registration ends and the entity is removed from the public list of registered distributors. Continuing requires a new registration and a new fee.

The interim national device registration under Art. 45 has no validity period and no renewal; the obligation is considered fulfilled once JAZMP announces on its website that the relevant EUDAMED modules (device registration, UDI database, notified body/certificate system) are available and the corresponding EU requirements are met; operator registrations under Arts. 15 18 instead require annual data confirmation.

A licence issued under regulation 5 (medical device establishment licence) is valid for a period of five (5) years from the date of issue.

If the licence expires, the applicant is prohibited from trading; late renewal submissions are refused and a new application is required.

An application for renewal of an establishment licence must contain the required information, be accompanied by the prescribed fee, and be made at least 90 days before expiry of the existing licence; SAHPRA states renewal applications submitted less than 90 days prior to expiry will not be accepted and a new application is then required.

type: fixed term · description: Manufacturing approval, certification or notification (제조허가등) is valid for 5 years from the date the approval/certification was granted or the notification was accepted.

The holder must renew the approval/certification/notification with the MFDS Commissioner before the 5 year validity ends; on renewal the validity is newly granted for 5 years and the permit certificate keeps its effect.

Renewal applications are filed 270 to 180 days before the expiry date (per e Medis official guidance; the Act itself only requires renewal before expiry and delegates procedure to the Prime Ministerial Decree).

Operating licences have a validity period not exceeding five years, renewable on request after verification of compliance; any modification of the conditions under which the licence was granted requires prior authorization by the granting body (AEMPS).

Economic operators must annually update their communication to the Registro de comercialización stating the products they continue to commercialize; failure to update causes removal (baja) of the products and of the operator from the Register. The IVD registro has the same annual update rule (RD 942/2025 art. 15.5).

Registration is renewed by re registration (RR) dossiers: NMRA publishes a Re Registration Dossier Accepting Checklist (Annex 2) and requires the previous registration certificate in RR dossiers; required acceptance documents are listed in the 30 June 2023 notice.

Full registration of devices is valid for five (5) years as specified in the certificate; renewal of registration is to be done every five years.

Provisional registration may be granted for one year for e.g. new devices, new specifications, new manufacturers, agency transfers, suspended products, or applications lacking required documentation; the 2021 exemption notice also granted one year provisional (IVDs approved by WHO or reference authorities) and one year conditional provisional registrations (COVID 19 essential devices) with performance evaluation pending.

After deregistration, the manufacturer or authorised representative remains responsible for keeping product documentation for ten years (fifteen years for manufacturers of implantable devices).

The Läkemedelsverket registration confirmation has no final validity date; confirmations are issued on registration, change registration and deregistration and are not re issued annually. The registration stands as long as the activity continues (annual fee payable); deregistration (or Eudamed inactivation) ends the right to make products available on the market.

type: route dependent · description: No Swiss product licence expiry exists for ordinary CE conforming devices (there is no national authorisation procedure); the time limited instrument is the conformity assessment certificate issued by a designated body: maximum 5 years validity, extendable on application by up to 5 years per re assessment, repeatedly (Art. 26 MedDO; identical rule for IVDs in Art. 22 IvDO); legacy devices continue under the Art. 100/101 MedDO and Art. 81/82 IvDO transition deadlines instead of a renewal mechanism.

Class I filers whose filing has been complete for one year must perform an annual declaration (年度申報) each October in the filing system, confirming the filed particulars and paying the annual fee, to maintain the filing.

The manufacture/import licence is valid for a maximum of five years from the issuance date. To continue, an extension must be approved before expiry; each extension may not exceed five years.

If the extension is not applied for before expiry, a fresh registration under Articles 5 and 6 of the licence regulation is required and a new licence number is issued on approval; for Class II/III devices re applied within six months after expiry a simplified document set (business permit, original licence, approved labels, free sale certificate, QMS evidence etc.) is accepted.

Extension applications must be submitted within six months before the licence expiry date, with the prescribed documents and fee (official processing limit: 60 calendar days, or 180 days where safety monitoring or post market study reports must accompany the extension).

The distribution permit is valid for three years. Extension is applied for between 12 and 6 months before expiry, each extension capped at three years, following the same application/inspection procedure. Name or address changes must be filed within 30 days of the change (original expiry not extended); changes to operations or storage sites go through the full inspection procedure again. Where a timely extension is undecided at expiry for reasons not attributable to the distributor, the permit stays effective until the decision date.

Registration of a medical device is valid for five (5) years and notification approval for three (3) years, unless suspended or revoked by TMDA or terminated by the registrant.

Continued validity of registration is subject to payment of annual retention fees as prescribed in the current Fees and Charges Regulations in force.

Applications for renewal of registration must be made at least 90 days before expiry of the existing registration, with a summary of all changes (approved and pending), specifications with batch certificates of analysis, label artwork and IFU, post marketing surveillance reports and two samples from the same batch.

The registrant may terminate marketing authorization of a device by giving TMDA 60 days written notice and reasons; TMDA may for stated reasons suspend or revoke the registration or amend its conditions.

type: fixed term · description: Notification receipts (ใบรับจดแจ้ง) are valid for 5 years from the date shown on the receipt; renewal extends validity for a further 5 years (renewal FAQ).

Renewal applications are not accepted once more than one month has passed since expiry; within one month after expiry the holder may still apply for renewal together with a waiver request showing cause, paying the renewal fee.

Renewal applications are filed no more than 90 days before expiry; after the one month post expiry window a new process is required.

daysBeforeExpiry: 90 · direction: no earlier than

years: 5

No AMC validity period is published for medical devices. The instrument's logic is a rolling two year evidentiary window rather than a stated expiry: products that obtained an AMC after 'avis' or after 'analyse' during the previous two years qualify for the systematic administrative AMC, and to obtain the administrative AMC the importer must attach the AMCs obtained during the previous two years. The only twelve month validity located in an ANMPS device related note attaches to a customs State monopoly derogation for reclassified hyaluronic acid products, not to an AMC.

Certificates issued by notified bodies remain valid for the period specified in the certificate, not exceeding 5 years, and may be extended at the manufacturer's application for additional periods not exceeding 5 years each.

Under S.I. 2014 No. 29 the term of a device registration is finite. The Authority issues a certificate of registration for a first registration which is valid for five years; the holder must pay an annual retention fee prescribed by the Authority for maintaining the registered product on the Register; and a certificate for renewal of registration is valid for one year from the date of issue. A renewal application must be submitted to the Authority at least 90 days before the expiry of the registration, in writing, and must be accompanied by a consolidated report of the changes made with respect to the registered product during the validity of its registration whether or not those changes were reported to the Authority, a report of additional adverse drug reactions detected during the lifetime of the registered product, five samples of the packaging in the form in which it is to be marketed, and the prescribed fee. The certificate must be kept at the premises of the holder.

Decisions of designated bodies under Annexes 3, 4, 6 and 7 of TR 753 (and TR 754) are valid for five years and may be extended for subsequent five year periods at the applicant's request within a period agreed in the contract.

A responsible person is excluded from the Register on grounds including expiry of the declaration/certificate of conformity, cessation of activity, non conforming devices, unreliable information, termination of the representative mandate, or written request.

Conditional marketing approval normally lasts one year, renewable for similar periods while its reasons continue. Renewal must be requested 90 days before expiry; activity cannot continue after expiry until renewal. EDE may grant a shorter term. If the reasons cease and the holder wishes to continue circulation, an ordinary marketing approval application is required.

type: fixed term · description: 5 years

The Marketing Rights holder may not continue the activity permitted by the marketing approval after expiry until renewal, unless EDE allows continued activities for some medical products where necessary.

Renewal grants a further five years (renewed certificate valid five years from the committee's approval date); the renewal request must be submitted 90 days before expiry; the EDE device renewal service completes in 15 working days.

There is no fixed duration product registration expiry: market access continues while the accepted conformity route remains valid (UKCA certificate, or CE certificate within the 2028/2030 transition) and the MHRA registration is maintained through the annual fee regime (GBP 300 per year per Level 2 GMDN Category for 1 April 2026 to 31 March 2027).

The former one off registration/renewal model has been replaced by an annual fee regime: the annual registration fee is GBP 300 per GMDN category (1 April 2026 to 31 March 2027), the payment deadline has been extended to 31 July 2026, and accounts that have not paid the annual fee remain active during this extended period.

510(k) clearances, De Novo grants, and PMA approvals are not annually renewed product authorizations: continuing lawful marketing is maintained through annual establishment registration and listing (21 CFR 807.22) and, for PMA holders, periodic reports under 21 CFR 814.84 plus supplements under 21 CFR 814.39 when changes occur.

There is no product certificate expiry for clearances/approvals; what lapses is establishment registration registration must be submitted each year between October 1 and December 31 (even with no changes) to remain active, and failure to maintain registration/listing or required PMA obligations disrupts lawful marketing.

Establishments subject to 21 CFR Part 807 renew registration and listing for each fiscal year during October 1 December 31 (21 CFR 807.22); PMA holders additionally file periodic reports and supplements as applicable.

Registration (registro) of a medical product is valid for 5 years.

Renewal must be requested before the Departamento de Tecnología Médica of the MSP in advance of expiry; if observations are raised there are 90 days to cure them, after which the renewal is deemed denied and the file archived. The registration certificate enables commercialisation of the products during its validity period.

Devices manufactured while the certificate was valid may undergo quality control, be imported and sold for 180 calendar days after the certificate expires, and used until their shelf life expires; the same 180 day rule applies after changes and after extension.

The device registration certificate is issued for a validity of five years. Under PF 137, registration certificates previously issued for an indefinite term are also capped at five years from the decree's entry into force.

The certificate validity extension application must be filed within nine months before expiry and is processed under the registration procedure; where no quality related changes were made, laboratory testing is not performed but the devices undergo mandatory post market control, and circulation and import are not suspended during extension. Extension applications must be accompanied by Uzbek clinics' conclusions on the device's safety and efficacy.

Class C/D circulation numbers are issued without expiry (indefinite, subject to ongoing compliance); import licences under the pre 2025 regime were extended only to 31/12/2024.

For Class C/D devices, the owner submits a commitment and request for continued circulation (Phụ lục IV Mẫu 01) and IMDA issues a written continuation decision (Mẫu 02); these decisions are decentralized to IMDA under Art. 2 item 5 of Circular 44/2025.

statement: A marketing authorisation granted by ZAMRA is valid for five years subject to terms and conditions the Authority may specify, the period running from the date of grant. The marketing authorisation holder must pay the annual retention fee prescribed by the Minister, and under the 2019 renewal guidelines an application for renewal of marketing authorisation should be submitted to the Authority five years from the date of grant or when requested by the Authority, whichever date is earlier. The Authority may suspend or revoke a marketing authorisation and remove the device from the register by written notice for reasons including non payment of the prescribed annual retention fee and an unforeseen high public or personal health risk associated with using the device.

statement: The device regulations state no validity period for an approval of a type and brand of condom or a type of glove. What they impose is an annual retention obligation: the fee payable for the retention of the right to sell a type or brand of condom, or of a type or brand of glove, is US$100, payable on or before 1 April annually. Batch approvals are separately time bounded for condoms, where the Authority approves a batch, 'such batch may be sold for such period as determined by the Authority'. MCAZ publishes registers of approved and retained condoms and gloves, which is how the current status of an approval is made public.