Official forms & portals by country

Current official submission channels are the e Albania government portal electronic services: 'Aplikim për regjistrim pajisje mjekësore' (No. 15128; business identification required), 'Aplikim për ndryshim regjistrimi' (No. 15129), 'Aplikim për anullim regjistrimi' (No. 15130) and 'Autodeklarimi i importit për pajisje mjekësore' (No. 15366); the registration form is annexed to Order 360/2016 and class I applications are made in electronic form to AKBPM.

ANPP Note N°28 2026 of 15 March 2026 sets the modalities for depositing device homologation dossiers in digital format; Note N°06 2026 of 14 January 2026 makes reception forms available for pharmaceutical products and devices.

Appointments for device (DM) filings are taken on the platform rdvdm.anpp.dz; the booking form opens every Tuesday from 10:00 to Thursday 10:00, and dossiers are received on Sunday, Monday and Wednesday.

Official ANMAT systems: GHEMA (habilitación of manufacturer and importer establishments), HELENA (electronic product registration, including IVDs), BONITA (import management, incl. import notices), ARGOS (adverse event and field safety corrective action reports), THEMIS (régimen simplificado per Disposición 8799/2025).

Since 1 November 2017 all trámites under Disposición ANMAT 5706/2017 (Class I/II registration, modification, reválida) must be filed electronically through the Sistema HELENA; both the Director Técnico and the apoderado must hold an ANMAT digital signature.

The applicant files the import (conformity) certificate application electronically through the 'National Single Window for Foreign Trade of Armenia' electronic system, attaching colour scanned copies of the required documents as PDF files; the applicant enters the imported medical devices in the application by commercial name. A paper application on the form set out in Annex No. 1 to the procedure is accepted only where the electronic system fails. The decree prescribes three forms: Form No. 1 for the application (addressed to the Ministry of Health), Form No. 2 for the expert conclusion of the Expert Organisation, and Form No. 3 for the import (conformity) certificate issued by the Ministry of Health. The certificate and a refusal decision are delivered to the applicant electronically through the Single Window, or on paper if the system fails; a paper copy of the certificate is issued free of charge within at most 2 working days on application.

Applications for ARTG inclusion are lodged through the TGA Business Services (TBS) portal; the sponsor needs a Client ID and TBS access before submitting a medical device application.

Applications, notifications, reports and other documents for clinical investigations of medical devices and performance studies of IVDs must be submitted to BASG mandatorily and exclusively electronically (per § 2 Abs. 3 Elektronische Einreichverordnung EEVO 2011) using the BASG web form at applicationform.basg.gv.at/mpgform; the confirmation of receipt is issued by the BASG PHAROS system; only electronic follow up submissions are accepted.

submissionSurface: EUDAMED (actor registration verified/validated by BASG; SRN issued on registration) plus BASG national surfaces: web form applicationform.basg.gv.at/mpgform for clinical investigations/performance studies (PHAROS confirmation of receipt), email medizinprodukte@basg.gv.at with MIR/FSCA forms for vigilance, online form tforms.basg.gv.at/meldung medizinproduktevorfall for users, and the GÖG register medizinprodukteregister.at · verifiedHighlights: Use of the EUDAMED Actor, Device and Certificate Modules mandatory since 28 May 2026.; Devices already on the market must be registered in EUDAMED by 28 November 2026 at the latest.; Certificates must be registered in EUDAMED by the notified bodies by 28 May 2027.

Applications for state registration of a medical device in Azerbaijan are made to the Ministry of Health (Nazirlik) on the application form annexed to the registration Rules as Annex No. 1 (1 nömrəli əlavə) — the same application form the Rules prescribe for medicinal products (Rules 3.2 and 4.2). The device dossier is examined by the 'Analitik Ekspertiza Mərkəzi' public legal entity (Qurum) and the registration certificate for a medical device is issued by the Ministry in the form set out in Annex No. 5 (5 nömrəli əlavə), and, where the data on an issued certificate change, in the form set out in Annex No. 6 (6 nömrəli əlavə). Both device certificate forms are headed 'QEYDİYYAT VƏSİQƏSİ / REGİSTRATİON CERTİFİCATE' and carry the certificate series 'TV №' (tibb vasitəsi), as distinct from the 'DV №' series used for medicinal products in Annexes 2A, 2B, 3A, 3B, 4A and 4B. The forms are annexed to and published with Cabinet Decision No. 345 of 18 July 2024 on the Cabinet's own site, and the same Rules are published in the National Legal Information System as framework 57583. No single online filing portal for device registration is created by these Rules; filing is a paper application to the Ministry on the annexed form.

Applicants book an appointment through the Ajheza system and submit documents on the booked date; NHRA reviews within 20 working days. Before registration, all devices must be listed by submitting the listing sheet (MDR Form Medical devices listing.xlsx) to medical devices@nhra.bh; only listed devices can be registered.

Application for device registration is made in the prescribed form to the office of the DGDA by the authorized person or local authorized agent, with the prescribed fee paid along with the application.

The registration certificate (регистрационное удостоверение) is issued on a security blank in the form annexed to CM Resolution 211; it states the applicant, the device per nomenclature classification, type/model/size (or custom order group), the producer and production site, the permitted medical use area and restrictions, the registration number and dates.

The current application for state registration (admin procedure 9.3.1) is the form approved under Minhealth Resolution № 42 of 12.05.2022; it requires, among other data: applicant/producer/site identification, nomenclature classification codes (ААА ББ ВВ ГГ), CE marking presence, indications and use, shelf life, price in the producer's country, and the ERIP (unified settlement and information space) payment reference.

Initial clinical investigation applications under the MDR use the national form EUMDRFORM v1 (with Annexes A/B/C and a prescribed folder structure) plus a GSPR/list of standards template; a written statement on suitability of sites is required and the new site suitability template (site suitability template MDR IVDR V2.0) is mandatory as of October 2023. Substantial modifications use the national 'Application Form Substantial Modification' (version 1.1).

The national submission surface is the FAMHP web portal (webmedseip, vas.ehealth.fgov.be): registration of activities (distributor, manufacturer, authorised representative, etc.), electronic free sale certificates, notifications for implants/long term invasive devices/mobile applications, custom made devices, in house devices and reprocessing, self check (risk analysis) forms, and the annual turnover declaration. EUDAMED covers the EU level actor/device modules, with importer registration in EUDAMED only since 28 May 2026.

Until 31 August 2026, free sale certificate applications may be submitted either via the FAMHP web portal ('My Free Sale Certificates') or by email to FSC.meddev@fagg afmps.be with subject line 'FSC – company name – country'. From 1 September 2026 only the online application is accepted and emailed requests are no longer processed.

statement: Form 027, 'Solicitud para Registro de Dispositivo Médico Equipo', is the official AGEMED application form for device and equipment registration. It records the type of procedure (inscription, reinscription, rectification, change, sanitary registration, commercialisation permit), whether the device is imported or national, the applicant company and its ministerial resolution and accredited professional, the manufacturer and licence and country of origin, and the product data (commercial and generic name, risk classification, international code, whether installation/operation/maintenance manuals are included, indications or use, presentation, storage and packaging, shelf life and disposal method). · article: FORM. 027

All data, the application, the list of medical devices and the complete documentation submitted to the Agency's registry office must be entered into the electronic application of the Sector for Medical Devices. Where one of the required original documents was already submitted with an earlier application, a copy of the document plus a statement naming the earlier application number is to be supplied. Documentation must be arranged in the stated order in a labelled binder, and the applicant must retain copies of the attached documents in its own archive.

Technical dossier submissions for registration must be made electronically through the BoMRA Regulatory Information Management System (BRIMS) Self Service Portal at https://brims.bomra.co.bw/. BoMRA's strategy confirms registration is done via BRIMS and that import/export permits are also lodged there.

Product petitions are filed electronically through ANVISA's Sistema de Peticionamento, identifying the applicable subject code (Código de Assunto); TFVS is paid by GRU before filing and petition status is tracked via Consulta à Situação de Documentos.

submissionSurface: BDA national forms plus EUDAMED shared layer · verifiedHighlights: BDA publishes separate forms for manufacturer/device registration and change (ЗМИ Art. 27(1)/(3); IVD form under Art. 28(1)/(3)/(7)) and for class IIa III device information/notification (ЗМИ Art. 30).; The official forms surface includes registration/change materials.

Article 8 of Prakas 1258 requires the documents of an application for visa registration of medical and dental devices to be written in Khmer, English or French.

The DDF website's 'sample application forms for visa/registration' folder contains a Word file with three letter templates addressed to the Minister of Health — a request for registration (បញ្ជិកា) of medical devices/reagents, a request for renewal of validity, and a request for a visa (ទិដ្ឋាការ) by a manufacturer or import export establishment — each citing Prakas No. 1258 ABS/OABS of 8 November 2012 as its reference, containing a product table (product name, composition, purpose of use, pack size, manufacturer, MAH) and listing the attachments: five original application copies, a copy of the establishment opening decision, a National Health Product Quality Control Centre analysis bulletin (for disinfectants), Free Sale Certificate, Certificate of ISO/GMP, Declaration of Conformity, Letter of Authorization, the technical file on USB, and a product sample or catalogue.

MDEL applications, amendments, notifications and Annual Licence Review are submitted by email only using the Medical Device Establishment Licence Application form FRM 0292; mailed applications are not processed.

MDL applications and amendments are filed through the Regulatory Enrolment Process (REP) at health products.canada.ca/rep pir: company enrolment via the Company (CO) template yields a company ID; a dossier ID is obtained via a request form; and a regulatory transaction template is required with each transaction filed to Health Canada, with a device details file required for new and catalogue affecting amendment applications.

submissionSurface: ANDIM page: electronic filing of the registro sanitario through the GICONA online system. The current filing sheet (9100003, v02 09/07/2025) directs the online form and payment through the SAFIS platform (safis.ispch.gob.cl) using clave única, with the resolution delivered in SAFIS 'Trámites Finalizados'; CDA applications run through GICONA. · exceptions: Registration of HIV detection IVDs (autotest) is filed in person at the Sección Gestión Productos y Servicios, ISP, Av. Marathon 1000, Ñuñoa, Santiago.

Device licensing items are standardized and published on the NMPA government service portal (zwfw.nmpa.gov.cn) as 办事指南 items covering forms, materials, fees and statutory clocks; e.g. import Class III first registration is administered by NMPA as a national level administrative licensing item.

Device filings use the Formato Único de Diligenciamiento de Dispositivos Médicos, code ASS RSA FM007 (includes a 'Modificaciones Automáticas' tab for modification requests); advertising authorization uses form ASS RSA FM096 and non commercialization notification uses ASS RSA FM107.

INVIMA filings run through the Oficina Virtual (app.invima.gov.co/ovirtual); UDI DI/semantic standard reporting uses estandar.invima.gov.co; adverse event reporting uses the tecnovigilancia web aplicativo at farmacoweb.invima.gov.co/TecnoVigilancia.

The application form must be digitally signed by the product holder or its legal representative or a person authorized by the representative; digitally signed documents must meet Banco Central integrity, authenticity and time validity standards.

All registration, renewal and post registration change applications must be filed through the Regístrelo platform (www.registrelo.go.cr), a 24/7 online single window connecting the public institutions involved, governed by Decreto 37988 S; users must register in the Regístrelo user registry with a digital certificate and make payments through the system.

The medical device listing declaration form is published on the AIRP website at www.airp.ci. Marketing authorisation applications are addressed in four copies to the Directeur Général of the AIRP, and the dossier (one hard copy plus two electronic versions, plus the original cheque and three copies) is submitted to the agency.

Registration applications use the Formulario de Solicitud de Registro in Anexo 1 of E 86 16 for Class I non sterile devices that need no Cuban measuring instrument model approval and are neither electromedanical/mechanical nor novel, and the Anexo 2 form for all other devices. Supporting evidences follow the corresponding Anexo A (with origin certificate) or Anexo B lists.

CYMDA publishes the forms and services of the competent authority on its portal page under the heading «Υπηρεσίες & Έντυπα» (Services & Forms). The list covers the user report form for a vigilance incident (adverse incident) with a medical device, the form for complaining about a breach of the medical device legislation, the notification of medical devices placed on the Cypriot market, the start of a clinical investigation of a medical device, and the substantial modification of a clinical investigation of a medical device. The portal page also points to the announcements section and to the authority's information material as the current source of information.

For export purposes, and on request from a manufacturer or authorised representative established in the Republic of Cyprus, the Cypriot competent authority issues a free sale certificate stating that the manufacturer or authorised representative, as the case may be, has its registered place of business in Cyprus and that the device bearing the CE marking under the Regulation may be placed on the Union market. The certificate is an outbound export document issued to a Cyprus established applicant; it is not a market access requirement for importing a device into Cyprus.

The ISZP portal carries the agendas: Persons (§§ 8 and 23 of the Act), Ethics committees (§ 13), Other clinical trials (§ 22, MDR Art. 82), Repackaging/relabeling (§ 7(4)), and Reimbursements (part seven of Act 48/1997 Sb.). Login is via system.iszp.sukl.cz and submissions requiring a signature must be signed with the 'ISZP Signer' application.

SÚKL is the founder, administrator and operator of the Information System of Medical Devices (ISZP), a public administration information system for collecting and managing data and for filing notifications and applications with SÚKL; where it does not serve public information, access requires assured identity. It contains data SÚKL obtains from the EU electronic systems (EUDAMED) and from national notifications under §§ 8, 10, 13, 23 and MDR/IVDR Art. 16(4).

Until EUDAMED is operational, the sponsor applies for a clinical investigation authorisation using the Danish application form 'Ansøgningsskema til ansøgning om tilladelse til klinisk afprøvning af medicinsk udstyr på mennesker' (available in English only), sent by e mail with all Annex XV documents to both the Danish Medicines Agency and the ethics committees; split submissions must be labelled (e.g. 'Mail 1 af 4').

Distributor and specialty retailer registration is done by logging in with MitID Erhverv and completing the registration form at portal.dkma.dk/mudregistrering ('Registreringsskema til medicinsk udstyr', also presented via virk.dk). DKMA processing takes up to 14 days from receipt; the registration is valid and fee liable from the date the form is submitted, and receipt is sent to e Boks. Changes are made by submitting a new form ('ændring i registrering'), new risk classes require a new registration, and cessation is selected as 'ophør i registrering'. Registration is per CVR number.

statement: DIGEMAPS registration transactions use numbered official forms: DGDF RP FO 001 for the registration application, DGDF RP FO 004 for a modification, DGDF RP FO 005 for the official technical sheet and DGDF RP FO 007 for the professional information sheet, each in the latest version published on the MSP website; the distributor habilitation file uses form FO UBP 01 and advertising requests use DIGEMAPS RS LI 058. Applications are created online or filed at the Dirección de Gestión de Servicios al Usuario of the Ministry of Public Health, through the portal https://servicios.msp.gob.do/portal. · sourceApproval: none · targetJurisdictionId: dominican republic · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

Within one year of obtaining the registration and before marketing, the holder must file the definitive labels printed with the granted registration number; this filing is made as a notification to the registration (NDM017 under Resolución ARCSA DE 2023 005 AKRG, as amended by the 2026 norm) and subsequent updates affecting approved definitive labels also follow the notification route.

Registration, re registration and modification applications are filed online through the Ventanilla Única Ecuatoriana (VUE) of the ECUAPASS portal: log in at portal.aduana.gob.ec, select ARCSA, use form 129 DM 001 REQ 01 (foreign manufacture) or 129 DM 002 REQ 01 (national manufacture), and sign electronically with a digital TOKEN; each form is limited to 100 items (50 for IVDs). Voluntary cancellation and ISO 13485 certificate registration are filed through the Quipux document management system until ARCSA implements a dedicated platform.

Registration, variations, import approvals, annual plans and special import requests are all submitted on the EDA MeDevice platform at medevice.edaegypt.gov.eg; responses, requirements and completions are exchanged through the same platform, with registration replies within 5 working days (normal track) or 3 working days (fast track).

The free sale certificate is a statutory service under § 32² of the Medical Devices Act. Ravimiamet issues it, on application, to a manufacturer or authorised representative registered in Estonia, for the export of a medical device; the certificate evidences that the applicant's registered place of business is in the Republic of Estonia and that the relevant CE marked medical device may be marketed in the European Union. The certificate is drawn up in English and in one copy, and is issued on paper. The manufacturer or its authorised representative applying for the certificate or a duplicate of it must, before submitting the application, pay the state fee for the issue of the certificate or duplicate in accordance with the State Fees Act. The certificate is valid for two years from the date of issue, unless the validity period of the medical device's conformity certificate is shorter. In practice the application is made on the form published in the medical devices section of Ravimiamet's website with the list of devices to be covered, and the completed form is sent to the medical devices department by email; before a certificate is issued the devices must be recorded in the medical devices register with up to date data and valid documents (declaration of conformity, EC certificate where applicable, label and instructions).

Device registration and marketing authorisation applications are submitted online through EFDA's Electronic Regulatory Information System (eRIS) at www.eris.efda.gov.et, after obtaining a username and password from the authorised person in the Authority's Registration department. Establishment licensing for importers, exporters and wholesalers is applied for through the EFDA licence portal at https://www.ilicense.efda.gov.et. Application forms, the agency agreement form, the payment request forms and the declaration of conformity and global market history templates are annexed to GDL/046 (Annexes II to VII).

Manufacturers, authorised representatives and importers must submit their Annex VI Part A Section 1 information to the registration electronic system (EUDAMED) before placing devices (other than custom made) on the market and before applying to a notified body where NB involvement is required; after verification by the competent authority, a Single Registration Number (SRN) is obtained from the system (Art. 31(1) (2) MDR). Device registration with Basic UDI DI and Annex VI Part B data precedes placing on the market (Art. 29(1) MDR).

Following the Commission notice on functionality (Commission Decision (EU) 2025/2371 of 26 November 2025) with its six month transition, four EUDAMED modules are mandatory to use as of 28 May 2026: Actor registration; UDI/Device registration; Notified Bodies & Certificates; Market Surveillance. The remaining modules (vigilance; clinical investigations/performance studies) will be released when they become mandatory.

Operator and device notifications are made either into the national CERE register via Fimea e services (sähköinen asiointi) or into EUDAMED for Finland established operators (manufacturer, importer, etc.); EUDAMED has been taken into use in Finland; notification roles include manufacturer, importer, authorised representative, distributor, custom made device manufacturer, system/procedure pack assembler, sterilisation service provider and in house manufacturer.

Until the EUDAMED clinical investigation module becomes functional (announced as not before 2028), clinical investigation applications for medical devices are submitted by email to ANSM, and ethics committee submissions are made through the SI RIPH system on the CNRIPH site.

nationalDeclaration: ANSM form (docx) sent preferably electronically to communications.dm@ansm.sante.fr (or by registered mail) for L.5211 3 1 activity declarations, changes, cessation and the materiovigilance correspondent · urgentSRN: contact.eudamed@ansm.sante.fr (subject 'Urgent demande de SRN') for urgent EUDAMED Single Registration Numbers for vigilance · derogations: demarches simplifiees.fr online procedure for CE marking derogation requests

Entry of a product into the Departmental Registry means that marketing authorisation in Georgia has been granted. The Registry records a registration number, the interested person, the manufacturing country, the brand name, the international off patent name (if any), the form, the dosage and, where necessary, the concentration, the registration date, the registration validity period and an electronic version of a packaging and labelling sample. It is a public document, kept in electronic form and made accessible through the internet. The application form for a device clinical investigation is set by the Agency rather than by the decree.

BfArM operates an 'Anträge und Meldungen' hub with online forms for: reporting suspected serious incidents (schwerwiegende Vorkommnisse), reporting recalls/field safety corrective measures, SAE/device deficiency reports in clinical investigations and performance studies, supply interruption notifications, informal classification/legal status applications (§ 6 Abs. 2 MPDG) and special authorisation (Sonderzulassung) applications.

The German Medical Devices Information and Database System (DMIDS, Deutsches Medizinprodukteinformations und Datenbanksystem) provides, among other functions, a central portal for applications, notifications and reports, including § 4 notifications, § 7 applications, § 6 decisions, applications/notifications under the clinical investigation chapter (Kapitel 4), and importer/distributor reports under § 81 MPDG.

submissionSurface: DMIDS (§ 86 MPDG central portal for national notifications, clinical investigation applications, vigilance/risk reports) plus EUDAMED for registrations mandatory from 28 May 2026; BfArM online forms hub for incidents, recalls and special procedures · verifiedHighlights: DMIDS is the statutory central portal for national applications, notifications and reports (§ 86 MPDG).; Product registration moved to EUDAMED on 28 May 2026; DMIDS capture of new product notifications deactivated.

FDA Ghana publishes distinct application forms for registration of Class I medical devices, Class II IV medical devices, and licence as an importer of medical devices; applications are submitted by cover letter addressed to the Chief Executive Officer, FDA, P.O. Box CT 2783, Cantonment Accra.

EOF publishes Greek language application forms for the Special Part of initial applications (DFME E4800 1 2 'Αρχική Αίτηση διεξαγωγής κλινικής έρευνας ή μελέτης επιδόσεων υπό τον MDR ή IVDR') and amendments (DFME E4800 2 2) for MDR clinical investigations and IVDR performance studies; IVDR performance study guidance 'Εφαρμογή του Κανονισμού (ΕΕ) 2017/746 στις μελέτες κλινικών επιδόσεων In Vitro Διαγνωστικών' V.1.2 (28.11.2024) applies.

submissionSurface: EUDAMED plus EOF national medical device register (GREMDIS at services.eof.gr/gremdis) and EOF forms for applicable national duties · verifiedHighlights: EOF publishes current medical device supporting documents and forms (forms page updated July 2026).; EOF separately maintains medical device notification, vigilance and distribution/production materials.; Clinical investigation applications: by email to protokollo@eof.gr (Τμήμα Κλινικών Δοκιμών) until EUDAMED is fully functional; device notifications: medicaldevices@eof.gr; vigilance: vigilancematerial@eof.gr.

statement: Related product inscription is applied for on MSPAS form F AS f 08, 'Solicitud de Inscripción Sanitaria de Productos Afines', whose current version is V 24 2025 and which enters into force on 2 February 2026 (version V 23 2025, entering into force 6 November 2025, is the immediately preceding one, still listed on the same index); updates to an inscription are applied for on form F AS f 10, 'Solicitud de Actualización de Inscripción Sanitaria de Productos Afines', version V 13 2025, entering into force 6 November 2025. All are published on the DRCPFA's 'Formularios de Inscripción Sanitaria' index and downloaded from it.

LRPs must report Hong Kong adverse events using the Medical Device Adverse Event Report Form, Form Eng AIR LRP (GN 03 Appendix 3), also available on the MDD website.

Listing applications must be made electronically through the Medical Device Information System (MDIS) using application form MD101 or MD102; New, Change, Renew, Delist and Takeover applications all run via MDIS.

The current official form for notifying MDR devices for distribution is 'Kérelem MDR szerinti orvostechnikai eszköz bejelentéséhez' dated 2025.09.15., published on the NNGYK distributor registration page.

National filings are submitted through Hungarian electronic administration (e ügyintézés under 2015. évi CCXXII. törvény, using Company Gate/cégkapu); the deviation permit application document must be completed and sent via e ügyintézés, with large files via transfer.ogyei.gov.hu.

Lyfjastofnun publishes its medical device forms on one official index. The device forms listed are: notification of an incident involving a medical device (web form); manufacturer's notification of an incident involving a medical device (web form); notification of an incident involving an implantable medical device (docx); notification of a serious incident in a clinical investigation; registration form for distributors (web); application for exemption from CE marking of a medical device (web); and application for a clinical investigation of a medical device. The index page was last updated 14 September 2026.

Import licence applications are made in Form MD 14 on the SUGAM online portal, with the licence issued as Form MD 15; state side applications use the Ministry's identified online portal.

Product registration runs on e Regalkes (regalkes.kemkes.go.id, User ID login) integrated with OSS RBA; import documentation runs through INSW; the e SUKA portal (esuka.kemkes.go.id, Directorate of Production and Distribution of Medical Devices) unifies 10 certificate types including CFS, Certificate of Export, Health Certificate and Research Use Only certificates, with PNBP e payment. Related systems: SIKLARA, e Watch, e Report, infoalkes, e Iklan.

Two official systems carry the process: the IMED portal (imed.ir) for company, product, import and distribution processes and the e service desk; and TTAC — سامانه تیتک (ttac.ir) — the FDA wide identity, registration code and track and trace system, with XML tracking label file support handled through support.ttac.ir.

KRG device import license applications are submitted online via erequest.kmcakrg.org (the type of materials is selected in the request); after electronic approval, fees are paid at the KMCA accounts section, the permit is printed at the printing section, and the file is received from the relations section.

Scientific offices must complete the 'scientific offices information accreditation form' (نموذج اعتماد معلومات المكاتب العلمية) so that data is collected and migrated into the Registration Department's electronic system; the office's account is activated after registration.

Clinical investigation applications and notifications (MDR Art. 62/74/82) are submitted to HPRA through the Common European Submission Portal (CESP), followed by an email to devices@hpra.ie with the CESP reference number; HPRA considers the application complete only after form, fee, CESP submission and notification email.

IVDR performance study applications and notifications are submitted to HPRA via CESP with an email to devices@hpra.ie quoting the CESP reference number; substantial modifications to approved studies are likewise notified via CESP until the EUDAMED performance study modules are functional.

submissionSurface: HPRA online 'Medical devices economic operator – registration form' (forms.hpra.ie/Economic Operator Form) for national registration of economic operators not registering via EUDAMED; EUDAMED for actors registering directly there · steps: Introduction; Organisation details; Contact details; Details of device types; Terms & conditions; Payment; Preview & submit · verifiedHighlights: Payment step collects the registration administration fee (fee code 431).; Registration applications are processed within 10 working days.

Registration applications to AMAR are submitted through the ministry's Caspit (כספות) portal (launched 25.1.2017, replacing email only submission); the 1.12.2024 extension announcement confirms renewal applications are filed in the Caspit system and an 'application submission confirmation' with a submission date is issued.

A register registration application must be filed electronically as an electronic registration form (PDF, version 9.0 recommended) plus a compressed zip of the required accompanying documents not larger than 250MB, and must be sent through the ministry Caspit (כספות) portal only.

Applications are an electronic form plus scanned attachments sent by email to amar@moh.health.gov.il; email size must not exceed 15MB (larger submissions are split into several emails, up to about 40 files). If no acknowledgment is received within 7 days (excluding concentrated government holiday periods), the application must be resent; during that period the applicant receives an intake confirmation with a reference number and device number, or a rejection notice.

Annex 1 of REG 2024/03 is the new applicant declaration for medical devices and IVDs on the regular registration track. The current Word (word) declaration file for download and completion is published on the ministry website; the PDF annex itself is the pointer, not a fillable form.

Until publication of the European Commission notice under MDR Art. 34(3) (EUDAMED mandatory use), the national provisions continue to apply for devices placed on the market under MDR Arts. 5 and 120(3), including the national procedures implemented in the Nuovo Sistema Informativo Sanitario (NSIS, Law 388/2000) for notifying vigilance and clinical investigation information under Arts. 10 and 16 of the decree; after the notice, the same communication modalities remain permitted until the abrogations of Art. 32(2) (9) (Art. 31(5)).

Current online submission surfaces: PMDA electronic submission data system (gateway system, esg.pmda.go.jp), MHLW FD申請 (web.fd shinsei.mhlw.go.jp), and the medical device WEB application platform DWAP (www.dwap.pmda.go.jp) for device programs/submissions.

JFDA operates an online portal (Login — JFDA) at https://application.jfda.jo/Cosmo covering medical supplies (medical devices) and cosmetics transactions.

Registration applications are filed electronically with EDS through the e Government portals www.egov.kz / www.elicense.kz (e Licensing database); expertise is conducted through the expert organization's information system (www.ndda.kz).

Applications are submitted through the PPB online portals: PRIMS (prims.pharmacyboardkenya.org) for marketing authorization and establishment applications, with an invoice generated upon completion of the form and payment required to complete the application; portal.pharmacyboardkenya.org serves IBR submissions; import/export permits run through the products portal. Statutory forms under L.N. 100 of 2022: Form 1 (application for registration, First Schedule) and Form 4 (renewal).

statement: The State Agency of Medicines maintains the LATMED electronic database, the medical device register, and is the controller of the LATMED state information system. LATMED holds information on manufacturers of class I devices and procedure packers established in Latvia, on notified medical devices and their manufacturers and distributors, on authorised representatives of manufacturers with no establishment in any EU or EEA state, and on incidents connected with the use of medical devices. · sourceApproval: · targetJurisdictionId: · edgeType: · marketAccessStrength: · regulatoryLayer: · localApplicationRequired: No · targetDecisionRetained: No

The MOPH created and maintains a web based registration system with direct download of medical device information: the National List of Implantable Medical Devices (LNDMI). Its purpose is to collect and update information on the companies commercialising medical devices (manufacturers, commercial representatives, importers, distributors) and to establish the market profile of implantable devices. The MOPH assigns a username and password to each declared supplier so it can access the online device registration system, and the identification sheet printed from that system must be attached to the registration application.

The national submission surface is the Amt für Gesundheit: health institution product declarations before putting into service (EWR MepV Art. 12; EWR IvDV Art. 14), custom made device declarations before supply (EWR MepV Art. 13), IVD first import reports (EWR IvDV Art. 8), and clinical investigation applications (EWR MepV Art. 14). Operator/device registration as such runs through EUDAMED (EU level) for the EEA channel and Swissmedic for the customs territory channel. Liechtenstein operates no national device database of its own in the EWR MepV/EWR IvDV.

Healthcare institutions submit in use medical device data to VASPVT (Akreditavimo tarnyba) by email in MS Word (DOC, DOCX) or MS Excel (XLS, XLSX) format, using the forms annexed to the Order (in use data form, cessation of use form).

Registration documents are submitted to the minister empowered institution (VASPVT) remotely, by electronic means through the contact centre, or by applying directly; the manner of submission is set by the Minister of Health or the authorised institution.

submissionSurface: EUDAMED (mandatory use from 28 May 2026) as the shared system, plus a national email channel: meddevices@ms.etat.lu for actor/device registration, custom made device registration and MDR Art. 59 / IVDR Art. 54 derogation applications; recherchebiomedicale@ms.etat.lu and meddevices@ms.etat.lu for clinical investigation applications (MDCG 2021 08 Annex I form); meddevices.vigilance@ms.etat.lu for vigilance (MIR form) · verifiedHighlights: National custom made device registration form (Word) published on the CA site; Derogation application form (Fiche de renseignement demande dérogation) submitted by email with complete dossier; Clinical investigation applications via MDCG 2021 08 Annex I form; safety reports via MDCG 2020 10/2 Rev. 1 form · caveat: No national online portal; email based procedures with Word/PDF forms continue until the respective EUDAMED modules are operational.

All applications (registration, renewal, changes, filing, licences) must be made on dedicated ISAF provided forms; gov.mo service pages identify form MD 001 for Class IIb/III registration and MD 005 for Class I/IIa filing, with online submission through the ISAF medical device e service (app3.isaf.gov.mo/mdws) or in person at ISAF.

Registration and establishment licence applications are made in forms determined by the Authority (submitted through MeDC@St); an export permit application is made in Form MDA1 under regulation 15(2) of MDR 2012.

MeDC@St (Medical Device Centralised Online Application System, current version MeDC@St 2.0+) is the fully web based portal through which all establishment licence and medical device (including IVD) registration applications, re registrations and change notifications are submitted; one account per applicant suffices for all application types.

Maltese medical device applications are made on the Authority's own numbered forms: MT MDF02 organisation registration, MT MDF03 revision or withdrawal of a device registration, MT MDF04 use of a non CE marked device on a named patient basis, MT MDF05 notification of devices made available on the local market, MT MDF11 application for a Medical Device Registered Person, and MT MDF12/MT MDF13 derogation applications. The forms are fillable and must be completed electronically — handwritten forms are not accepted — and a signed scanned copy of the completed form with supporting documentation is submitted by email to mdforms.medicinesauthority@gov.mt. A declaration form is attached to each e form.

COFEPRIS trámites (including device registration, prórroga and clinical protocol applications) are filed electronically on DIGIPRIS Regulación en Línea (digiprisregulacionenlinea.cofepris.gob.mx) using a valid advanced electronic signature (firma electrónica avanzada); COFEPRIS communications state registrations are extended through the Digipris electronic platform.

CE track dossiers are filed through the electronic service "personal cabinet of the authorised representative", accessible from the AMDM website, and the same platform is used for the manufacturer registration request, the device application, the deregistration request under Annex 3 and the payment. The resulting State Register of Medical Devices is published as a public portal by AMDM. AMDM also publishes a separate electronic platform for medical devices.

For devices without CE marking the manufacturer or its authorised representative must register them with the Agency before placing them on the market, filing the form set out in Annex 1 to the 2018 administrative procedures in 2 copies, completed with the requested data and accompanied by the documents specified in it. The registration procedure begins with a pre validation check based on the dossier registration form; if pre validation succeeds the registration dossier is filed at the Agency's single window, and otherwise the registration dossier together with the form is returned to the applicant for completion. The dossier is presented on paper and electronically in PDF, accompanied by the applicant's declaration on own responsibility as to the veracity of the data presented, and the applicant groups the electronic documentation by compartments and chapters.

Once the registration documents are complete, the applicant for laboratory diagnostic device (IVD) registration files them with the Medicines and Medical Devices Control and Regulatory Agency through the 'E business' electronic system (Е business цахим систем) and is issued a number; the registration fee must then be settled within 5 working days.

An application to enter medical equipment into the medical device list is made up of the applicant organisation's official letter and the original application for entry of the device into the list in Mongolia, countersigned by the manufacturer's authorised official with a signature or electronic signature and the company seal; the same two documents open the package for medical consumables. Both packages are filed with the Medicines and Medical Devices Control and Regulatory Agency.

statement: An application to register a medical device, to renew its registration period, to amend or supplement registration data, or to delete a device from the register of medical devices, is filed on the prescribed form for the class: for class I medical devices, Form 1 (Obrazac 1); for class IIa, IIb and III medical devices, Form 2 (Obrazac 2); for in vitro diagnostic medical devices, Form 3 (Obrazac 3); and for active implantable medical devices (AIMD), Form 4 (Obrazac 4). The forms are set out in the Annex, which forms an integral part of the rulebook. · formsByClass: I: Obrazac 1 · IIa/IIb/III: Obrazac 2 · ivd: Obrazac 3 · aimd: Obrazac 4 · annexStatus: The forms are given in the Annex, which forms an integral part of the rulebook.

DFDA operates an official e submission portal ('E Submission of Food, Drug, Medical Device and Cosmetic System') at esubmission.fda.gov.mm covering medical device submissions, with account registration, login, a product validation check (search product) and a user manual guide.

Medical device import applications start with an online booking at https://onlineservices.fda.gov.mm to obtain a submission date, selecting an individual or grouping category.

submissionSurface: NOTIS (https://hulpmiddelen.farmatec.nl, login with eHerkenning level 2+) for national notifications, custom made device registration, export certificate applications and mutations; EUDAMED for actor/device registration from 28 May 2026; Article 59 MDR / Article 54 IVDR exemption applications by email to CIBGOntheffingenMedischeHulpmiddelen@minvws.nl; vigilance reports (MIR/FSCA forms) by email to meldpunt@igj.nl · verifiedHighlights: Farmatec's page reflects mandatory EUDAMED device registration from 28 May 2026 (Besluit (EU) 2025/2371).; Custom made device and mutation handling remains in NOTIS (mutations online until 27 November 2026).; Export certificates (certificates of free sale) are applied for in NOTIS with eHerkenning 2+ login.

portal: WAND (Web Assisted Notification of Devices) online database · accessSupport: devices@health.govt.nz · adverseEventForms: Medsafe adverse event report forms published separately for industry (sponsors), health professionals, and consumers

Device registration applications are submitted and processed on the NAPAMS portal at https://registration.nafdac.gov.ng; to initiate an IVD/non IVD dossier submission the applicant emails md.vbmrr@nafdac.gov.ng to receive a unique upload link.

The online application form for product registration renewal is purchased on the NAFDAC registration portal (http://registration.nafdac.gov.ng) and completed for each device, IVD and related product requiring renewal.

MALMED publishes the medical device application forms for download: Образец бр. 1 (class I devices), Образец бр. 2 (classes IIa, IIb and III), Образец бр. 3 (in vitro diagnostic devices), Образец бр. 4 (active implantable medical devices), the parallel import application form 'Барање за одобрение за паралелен увоз на медицински средства – образец ПУМПС', and an application form for a wholesale activity register entry. The devices forms page sits under the Agency's medical devices section alongside the rulebooks and the guidance pages.

Until EUDAMED is available, clinical investigation applications are submitted by email to kki@dmp.no with the subject 'Søknad om klinisk utprøving av medisinsk utstyr' plus sponsor and device names; DMP provides national forms/templates (Application Notification form, cover letter, MDR Annex XV checklist, GSPR/standards checklist, statement of conformity).

submissionSurface: EUDAMED · details: Actor and device registration in Norway takes place in EUDAMED; the CA (dmp.no) publishes the registration pages. Clinical investigation submissions use a separate national channel (email kki@dmp.no) until EUDAMED is available.

Device adverse events/complaints are reported using the Medical Device Reporting Form (published at moh.gov.om/media/pbybg2yj/medical device reporting form 15072026 1.pdf) to the Medical Device Vigilance Section at vigilance md@moh.gov.om; general device queries: med device@moh.gov.om.

All device services (registration, re registration, manufacturer registration, variation, import of unregistered devices, release, activation) are submitted online through the MoH E Health portal; GD 22 instructs applying through the online portal and documenting all dossier sections in the online platform.

Circular No. 22 of 2026 (04/03/2026) invited stakeholders to a training workshop on the Taawon 2.0 system for medical device registration, indicating the current registration platform.

Medical device licensing and registration applications in Pakistan are filed through DRAP's online MDMC portal at e.dra.gov.pk ('New MDMC Licensing and Registration'), which coexists with a legacy 'MDMC Licensing System (OLD)' for previously submitted license applications.

MINSA publishes the current DNDM forms: Formulario de Declaración Jurada, Formulario Listado de Dispositivos Médicos a Comercializar, and Formulario de Solicitud de Licencia de Operación, plus the Registro Implantable spreadsheet for the implantable registry. Submissions are paper/e mail based (formularios .doc/.xls on minsa.gob.pa); the draft decree directs progressive migration to electronic platforms with AIG.

Device applications are built in the Sistema Informático Integrado de Gestión de Registros Sanitarios y de Establecimientos de Salud (DINAVISAPy): the responsible technician declares the device class there with the technical justification, DINAVISA evaluates the technical information declared there, and establishment opening, renewal and modification applications already in progress also run through that system.

Applications use the Solicitud Declaración Jurada form capturing applicant category (laboratorio/droguería), RUC, director técnico, product group (DM / Equipo Biomédico / EBTC), universal nomenclature, and 'Código de Identificación (según el estándar internacional)'; requisito 9 requires the device table (Cuadro DM/DB/DBC or DMDIV) printed and on magnetic media. Official formats: Formato DMIMM 001, DMEB 002, DMDIV 003, FormatoDISMED II.

Device registration procedures are filed electronically through the Ventanilla Única de Comercio Exterior (VUCE) at https://authorize.vuce.gob.pe/public/login options/mercancias restringidas, with in person alternative at DIGEMID, Av. Parque de las Leyendas 240, San Miguel.

Initial CMDN applications for medical devices must be filed online through the FDA eServices Portal System at https://eservices.fda.gov.ph/; the Circular does not cover CMDN renewal and variation applications, which are submitted to the Food and Drug Action Center (FDAC) by email at fdac.letters@fda.gov.ph; the old ePortal CMDN application is deactivated upon effectivity.

For Class B, C and D devices, initial applications for CMDN are no longer accepted; applicants are required to apply for a Certificate of Medical Device Registration (CMDR), with applications transmitted via email to FDA (FDAC) and processed through the FDA Web Support System which issues the Order of Payment and Document Tracking Number.

Beyond EUDAMED, URPL operates national surfaces: SRN applications on Forms 1 4 with filling instructions; the distributor register at d.urpl.gov.pl; the healthcare provider import register at lg.urpl.gov.pl; the custom made producer register at wnz.urpl.gov.pl; and the e Doręczenia address AE:PL 26545 10069 UIJGF 16 for the Art. 29 permit, Art. 52 opinions, and clinical investigation and performance study applications; serious incident reports go to incydenty@urpl.gov.pl or the same e Doręczenia address.

INFARMED operates SIDM (Sistema de Registo de Dispositivos Médicos), the national on line registration system for devices and IVDs, articulated with EUDAMED to avoid duplicate registrations; completing a record with labelling, IFU and declaration automatically assigns the CDM (Código de Dispositivo Médico), published on the InfoDM public search portal; free sale certificates are requested via SIDM.

The Department of Healthcare Professions website links the 'Implanted Medical Device (IMD) Registration Portal' at imdr.moph.gov.qa; the portal itself is access restricted (external requests receive an official MoPH access denied page referencing soc@moph.gov.qa).

Official surfaces: the MoPH Implantable Medical Device Registration Application form with Application Documents Checklist (PDF on moph.gov.qa) and the Implanted Medical Device (IMD) Registration Portal at imdr.moph.gov.qa (login gated; external access returns an official MoPH access denied page).

The sponsor or authorised representative submits the clinical investigation application to ANMDMR using the application form in Annex 1 to MDCG 2021 8 (Commission document); submissions and SAE reporting go to dscdm@anm.ro.

ANMDMR verifies data entered by manufacturers, authorised representatives and importers in EUDAMED, obtains the Single Registration Number from the system and transmits it; per the ANMDMR page it validates, rejects or requests corrections, and a separate registration with different SRN applies per role.

Applications and documents are submitted electronically through the applicant's unified personal cabinet subsystem of the Unified Portal of State and Municipal Services (EPGU / Госуслуги); Roszdravnadzor publishes official DOCX application forms on its page, including 'Application for state registration of a medical device' and 'Application for resumption of state registration'.

An application for registration or notification of a medical device is received only through the Rwanda FDA online portal; applications and queries are handled there, and a reference number is assigned on receipt and used in all subsequent correspondence. Where samples are required, they are delivered to Rwanda FDA headquarters reception with the cover letter and a printed email notification bearing the application reference number generated at submission. The application forms are the appendices to guideline DHT/GDL/024: Appendix 1 cover letter, Appendix 2 notification application form, and Appendix 3 device registration application form.

MDMA applications are submitted electronically via the GHAD System Marketing Authorization Services using the 'Application Form for Medical Devices Marketing Authorization'; establishment licenses (manufacturer and AR) are likewise obtained through GHAD System Licensing Services.

The registration application is submitted on Obrazac 1 (Form 1), printed as an integral part of the registration bylaw and published by ALIMS in the 6/2023 version; it is completed in the part relating to registration and is accompanied by the device documentation and proof of fee payment. The attached device list requires trade name with types/models, generic device group, package content, GMDN/EDMA/EMDN and UDI coding, and catalogue numbers.

Incident reporting by the manufacturer/authorised representative to ALIMS is performed electronically through the Agency portal; if an initial report was given orally (e.g. by phone), a written report follows without delay. Initial, follow up and final reports are submitted on Prilog 3, with manufacturer incident data per Prilog 4 of the vigilance bylaw.

Adverse event reports must use Form MDAR1 for events not related to a clinical trial, and Form CTB MD AE for events related to a clinical trial (submitted to the Clinical Trials Branch). Submissions may be by email or postal mail as described in the forms; email submissions should use the interactive PDF AE report form.

SHARE is HSA's online portal for device transactions: new product registration, change notification, change of registrant, withdrawal, fulfilment of approval conditions, cancellation, Class A product notification and dealer's licence applications; Corppass login is required from 14 July 2025. Adverse event reports by dealers use the Mandatory Medical Device Adverse Event Reporting Form submitted by email.

National device filings are made in paper form to ŠÚKL's podateľeňa (counter) or by post, or electronically via the Central Government Portal ÚPVS (www.slovensko.sk). Current ŠÚKL section ZP forms include TL SZP 021 (clinical investigation application), TL SZP 066 (IVD performance study application), TL SZP 070/026 (distributor registration), TL SZP 075 (serious incident report), TL SZP 052 (free sale certificate request) and TL SZP 037 (fee settlement proposal). Administrative fees are paid via the eKolok system against a payment order generated per filing.

Manufacturers and importers register electronically via 'Registracija v EUDAMED (Actors Modul)'; a signed 'Izjava o odgovornosti za informacijsko varnost' must be uploaded (signed with a qualified digital certificate such as SIGEN CA, SI PASS; hand signed originals go by post to JAZMP, Slovenčeva ulica 22, Ljubljana); JAZMP assigns the SRN; the declared risk class must be stated; cessation is reported with form Obr. 861 03 within 8 days.

Distributor/importer registration applications with JAZMP are filed electronically via the Slovenska poslovna točka (SPOT) government portal (or physically to JAZMP); any person authorised by the business entity may submit; changes and deletions are filed the same way; legal remedy is an appeal decided by the Ministry of Health.

Current SAHPRA medical device forms: GLF MD 06A 'Licence Application Medical Device Manufacture'; GLF MD 06B 'Licence Application Medical Device Wholesaler Form'; GLF MD 06C 'Licence Application to Import Distribute or Export Medical Devices'; GLF MD 11A 'Medical Device Adverse Event Reporting Form'; GLF MD 17A 'Application for Clinical Investigation of Medical Devices'; GLF MD 21A 'Application for Certificate of Free Sale for Medical Devices'; GLF MD 25A 'Application to Import Section 21 Ruo Medical Devices Including IVDs'.

The cited SAHPRA guidance directs establishment licence applications to mdadmin@sahpra.org.za, with mdcovid@sahpra.org.za copied for applications including COVID 19 testing kits; vigilance reports go to mdvigilance@sahpra.org.za and recalls to recalls@sahpra.org.za.

e Medis (의료기기전자민원시스템, emedi.mfds.go.kr) is the official electronic civil affairs system through which product permits/certifications/notifications and renewals are filed and processed.

Clinical investigation authorization applications are made by written request of the sponsor to the Director of AEMPS and, until the EUDAMED electronic system is available, are submitted through the general electronic register of the state administration (Registro Electrónico General) or on paper at the AEMPS register; MDR Article 74(1) investigations are notified in Spain to the AEMPS database NEOPS.

RECOPS is the AEMPS electronic application (via AEMPS sede electrónica) for the commercialization registration of devices other than custom made and of IVDs; from 28 May 2026 no new communications are accepted through the former CCPS and RPS registers (which remain available for consultation only), except communications by custom made device manufacturers, for whom RPS remains mandatory.

Dossier reference numbers indicate route: D/Serial Number (non reliance listed/general/IVD), D/Serial Number/F (non reliance with FMSA), D/Serial Number/RLC (reliance general medical devices except Class I, and IVDs), D/Serial Number/RLC/F (reliance with FMSA), D/Serial Number/L (locally manufactured, with NMRA GMP audit); low risk dossiers use D/Serial Number/LR.

submissionSurface: NMRA online Google Form pre submission followed by physical dossier at the Dossier Accepting Point (2nd Floor NMRA); two copies of the relevant checklist must accompany the dossier · acceptanceWindow: Every Tuesday, 9:00 a.m. to 3:00 p.m. · forms: Application form A; Application form B; Application form C for Sample Import License; Application for registration of Foreign Manufacturing Site (FMSA); Application for Waiver of Registration (WOR); Annex 1 consolidated new dossier checklist; Annex 2 re registration checklist; F MDR 046 low risk checklist · note: An e NMRA digital platform exists but the current hub prescribes the Google Form + physical dossier route

Läkemedelsverket e services are the national submission channel for registration, change and deregistration of actors/products, for serious incident reports (EU MIR form uploaded in PDF and XML), for FSCA reports, and for dispens applications; Eudamed is the registration channel for manufacturers, authorised representatives and importers of CE marked products. The agency does not perform registrations on an actor's behalf.

Actor and mandate registration is done in the swissdamed portal (legal basis TPA Art. 62c): access requires CH LOGIN (Swiss federal government login), with Swiss companies verified against the Zefix commercial register; upon approval of the registration request, Swissmedic sends a confirmation e mail containing the CHRN.

Official channels: the medical device registration electronic submission system (醫療器材查驗登記電子化送件系統, https://mds.fda.gov.tw/) for Class I (non filing) registration, Class II/III registration, licence changes and extensions; and the FDA online application platform (食品藥物管理署線上申辦平台, http://oap.fda.gov.tw/) used for Class I filing (登錄). Certain Class II/III case types must be filed electronically since 2025 07 01, Class I non filing registration electronically since 2026 07 01, with e payment via credit card, ATM, bank counter or convenience store.

All application fees are non refundable and must be paid by the control number issued through the TMDA invoice; bank transfer charges are borne by the applicant, who must send an advice note identifying the applicant, device and amount paid (plus registration number for registered devices).

Applications are made through the TMDA Trader Portal: application invoices are sent to applicants via the portal and payment receipts are returned through the Trader's Portal.

Medical device registration documents are filed electronically through the SKYNET e submission system.

Adverse event and field safety corrective action reports are submitted via the HPVC channel of the SKYNET system, the main channel for receiving forms รมพ. 1, 2 and 3.

An application for an Autorisation Provisoire d'Enlèvement (APE) for a medical device is filed as a single bound dossier conforming to the 'Check list APE' published on the ANMPS website, structured in two parts: part one holding the documents the check list requires for the APE, part two holding the documents needed for the administrative AMC (signed commitments, AMCs issued after an analysis bulletin and less than two years old, with the corresponding invoices where the references do not appear on the AMCs). The application form is not a blank government form: the importer completes it on the ANMPS dedicated application and then prints it, stating the references eligible for an administrative AMC. Product references are entered in the « Références » section of the ANMPS platform. A labelling mock up must be joined where the AMCs or invoices do not clearly establish that the products are the same.

To obtain an administrative AMC for a medical device at importation, the importer must sign the form « Engagement pour le CTI », listed as Pièce Jointe 1 of the CTI procedure with identifier F OP2 001 FR, one single such engagement for each importation, and must also hold a technical dossier conforming to the requirements, pay the AMC fee, attach the AMCs obtained during the previous two years, and provide a copy of the labelling (labelling mock up) or any other document identifying the articles by trade name.

The import technical control (CTI) activity for medical devices was transferred from the Laboratoire National du Contrôle des Médicaments (Beb Saadoun) to ANMPS headquarters. From 20 April 2026 the whole CTI service and its staff operate at 40, Rue Hedi Nouira 1023, Tunis, and all correspondence, administrative steps and visits must be made exclusively at that new address. The deposit of samples and of the documentation required for evaluation, and the payment of the fees, remain at the Laboratoire National du Contrôle des Médicaments (Beb Saadoun).

TİTCK operates the clinical investigations portal at kap.titck.gov.tr for clinical investigation submissions under the Medical Device Regulation.

The ÜTS (Ürün Takip Sistemi) is the national product tracking infrastructure for devices produced in or imported into Turkey; company, document and device registration processes are governed by the TİTCK guide TCKKD KLVZ 03, whose legal basis is Madde 34 of the Medical Device Regulation and Madde 32 of the IVD Regulation.

The device application form is Form 7, prescribed by reg. 27(2) of S.I. 2014 No. 29 as Schedule 6 to those Regulations: 'APPLICATION FORM FOR THE REGISTRATION OF SURGICAL INSTRUMENTS', printed under the heading 'NATIONAL DRUG POLICY AND AUTHORITY ACT, CAP 206'. The certificate of registration is Form 8, prescribed by reg. 30(2) as Schedule 7. The format of the register of surgical instruments is Schedule 5, prescribed by reg. 26. DAR/GDL/028 wraps the statutory form set in its own appendices: Appendix I is Form 7 with the product and manufacturer detail and the submission checklist, Appendix II is the IMDRF Essential Principles conformity checklist, Appendix III is Form 8, Appendix IV is the register format, Appendix V is the form for variation of a registered surgical instrument or appliance, and Appendix VI is the application submission checklist. NDA publishes the current downloadable form set on its Application Forms page, which lists the application form for the registration of surgical instruments, the application form for variation/alteration of a registered surgical instrument/appliances, the Essential Principles checklist for registering surgical instruments and appliances, and the classification rules for surgical instruments and appliances.

Notifications to the Register of responsible persons are submitted through the electronic user cabinet (hosted at drmvcitizen.moz.gov.ua, linked from dls.gov.ua) using a qualified electronic signature; the Register is public and accessible only via the official DLS website in the 'Ринковий нагляд' section, with API data exchange.

Device services (classification, marketing authorization, variations, advertisement approval) are submitted through the EDE website (www.ede.gov.ae) with UAE PASS login and e payment.

Device registration with MHRA is done through the self service Device Online Registration System (DORS); the applicant must create a DORS account before registering devices and is not registered until device details are provided and MHRA confirmation is received.

Clinical investigation notifications are submitted electronically to MHRA through the Integrated Research Application System (IRAS); applications are validated against MHRA's clinical investigation application checklist and the statutory fee must accompany the notice when it is given.

Since October 1, 2025, all De Novo request submissions, unless exempted, must be submitted as electronic submissions using eSTAR (Electronic Submission Template and Resource).

MSP publishes the FO 13222 series for technology evaluation trámites, including: FO 13222 006 registration of equipo médico; 007 reactivo de diagnóstico; 008 dispositivo terapéutico; 009 general product registration request; 010 model registration note; 011 Class I declaration; 016 certificate of negative registration; 017 request for evaluation prioritisation; 018 change of Dirección Técnica; 019 unregistered medical products; 020 patient informed consent; plus verification checklists LV 13222 001 to 004.

The PIRM trámite is performed by a logged VUCE user of a VUCE registered company (or the customs broker), using digital signature the Uruguayan identity card with DNIC PIN or an advanced physical person signature with token; the form must obligatorily be signed by the company's Director Técnico. Operation is started with Código de Régimen 'REGISTRO / ESPECIALES', Entidad 'Ministerio de Salud Pública', Trámite PIRM.

From 26.02.2026 new state registration applications for medical devices are filed through the Centre's information system «Darmon»; under the Regulation the documents are uploaded individually into the Centre's information system confirmed by the applicant's electronic digital signature. The my.gov.uz service page (service 330) still exists but cites the repealed CM Resolution No. 213 (2018).

Current administrative forms are Mẫu 01 16 of Circular 44/2025: 01 production conditions declaration; 02/03 Class A/B standard application declaration; 04 08 Class C/D new applications (QCVN based; measuring instruments; fast track; urgent; other); 09 buy/sell conditions (B/C/D); 10 import licence; 11 free sale certificate; 12 14 dossier update notifications; 16 advertising disclosure.

statement: The device application uses the application form set out in Annex 1 of the guideline and the checklist set out in Annex 2, which must be completed indicating the sections of the application completed and their page numbers. The dossier is presented in electronic text selectable/editable PDF and submitted via the Authority's online portal.

statement: Zimbabwe's device process runs on four statutory forms set out in the First Schedules to the two sets of regulations: Form M.C.Con.1 for approval of a type and brand of condom and Form M.C.Con.2 for testing batches of condoms; Form M.C.G.1 for approval of a type of glove and Form M.C.G.2 for testing batches of gloves. Each is submitted in duplicate to the Director General at MCAZ, 106 Baines Avenue, Harare, or lodged at the Director General's offices. Alongside them MCAZ operates form SR 03 (Rev 7, October 2020), the Sample Receipt Form Medical Devices, used by its Samples Repository Office. There is no online device registration portal: MCAZ's Quality Assurance page states that the online sample submission link is 'currently available for Medicines only' and that sample receipt forms 'have to be submitted in person with the samples to the MCAZ Samples Repository Office'. MCAZ publishes registers of approved and retained condoms (MDF 039) and gloves (MDF 040) on its Medical Devices registers page.