Dossier requirements by country

Registration dossier (Order 734 point 5, reformulating Order 360 point 16): (a) request letter to AKBPM; (b) application form; (c) photocopy of the manufacturer's Declaration of Conformity with data specific to the device classification and/or the CE certificate; (d) for custom made and clinical investigation devices, the declaration per Annex VIII of VKM 731/2015; (e) proof of the 500 lekë application fee paid at a second tier bank. The form must be completed in Albanian and collects the customs nomenclature code, GMDN or UMDN code, device category, description/intended use, manufacturer and model, notified body name/number, CE certificate number, link to the certificate on the official company or notified body website, issue/expiry dates and the standards met; for class I devices, the Declaration of Conformity plus link and standards list.

Filing a homologation or renewal dossier is subject to payment of the droit/redevance by the applicant establishment; a quittance evidencing payment must be attached to the dossier (ANPP Note N°47 2025 of 4 December 2025 specifies the payment proof documents for registrations and device homologations).

The dossier content (administrative data; technical summaries; chemical/physical/mechanical/biological information incl. sterilization validation and risk evaluation; performance and non clinical reports; clinical reports) is presented in five parts per the annexes to the 10 May 2021 arrêté, with a strictly defined numbering system; the same format applies to homologation, renewal and modification applications.

On ANPP request the applicant establishment must submit the device and, where applicable, its raw materials, intermediates or other components, reagents and specific means needed for quality control of the finished product; ANPP notifies the quantities to be submitted.

The certificate of registration or free sale from the country of origin submitted with Class III/IV registration applications must be no older than 24 months.

Foreign documents in Class III/IV registration dossiers must be legalized under the Consular Regulation or by Hague Apostille and translated by a public translator (traductor público).

For registration of an imported device, the manufacturer's declaration may be up to 2 years old from issuance and must be legalized or apostilled; proof of registration, a free sale certificate or an equivalent document must also be submitted.

For every imported medical device the applicant files a common set of documents: the import application, and an invoice signed by the supplier with the mandatory indication of the series (serial number, lot, batch), quantities and EAEU HS codes of the imported products (the information on series and quantities may also be supplied by another shipping document signed by the supplier) (Annex No. 2, para. 1). Case specific documents then apply. For devices with Armenian state registration: a quality conformity certificate for each series (batch), if applicable, or another document certifying quality with the series (batch) indicated, issued by the manufacturer or its authorised representative (for used devices, the description of the refurbishment work and the conclusion on conformity to safety, quality and effectiveness after that work), and a copy or the particulars of the Armenian state registration certificate certified by the applicant (para. 2(1)). For devices without Armenian state registration: the origin country or IMDRF member authorisation evidence, the batch quality document, the instructions for use or a reference to their electronic version, and, if the need for the information on the marking arises during the examination, clear colour photographs or diagrams of the device showing the marking clearly (para. 2(2)). Further case specific lists apply to humanitarian aid imports, devices for diagnosing new or especially dangerous infections, emergency/martial law devices, state needs and named patient imports, clinical and clinical laboratory investigation devices, scientific research devices, technical/biological/metrology test samples and exhibition devices (para. 2(3) (10)).

requirement: Class specific documents (per Table 2 of TGA's market authorisation evidence guidance) must be attached to the TGA application to pass preliminary assessment · australian deltas: Australian Declaration of Conformity made under Schedule 3 of the MD Regulations (a declaration to the European MDD requirements is not acceptable); Product information supplied with the device must be clear, legible and in English; Clinical evidence substantiating Essential Principles compliance (Schedule 1 and Part 8 of Schedule 3) · mra note: Certificates issued under MRAs may no longer be acceptable for some higher risk devices including Class III and AIMDs

Upon reasoned request of BASG, all information and documents required to demonstrate the conformity of the product must be submitted in German.

The device registration dossier submitted to the Ministry with the Annex No. 1 application comprises: a copy of the document confirming the manufacturer's right to manufacture, with its annex; the origin/registration evidence of §4.2.2 (notarised Azerbaijani translation); the manufacturer's short description of the device's fields of application, intended purpose and accessories; the manufacturer's labelling and packaging information including colour mock ups and Azerbaijani language content; where the device contains a medicinal substance, its composition, quantity and compatibility data; the manufacturer's biological safety information; for sterile devices, a notarised Azerbaijani translation of the manufacturer's document on test methods, packaging validation, bioburden, pyrogenicity and sterility test results and process validation; the manufacturer's declaration of conformity of manufacture with safety and effectiveness requirements stating the risk degree; a copy of the manufacturer's quality management system certificate; the documents required by Articles 18.2.1–18.2.3 of the Law on Licences and Permits; and, for used devices, a copy of the manufacturer's serviceability document. Items §4.2.1, §4.2.2, §4.2.8 and §4.2.9 do not apply to devices manufactured in Azerbaijan.

The Bahraini registration dossier has seven unconditional items technical details (IFU, leaflet or user manual), artwork/label, the manufacturer's authorization letter to the authorized representative, a relationship letter stating the link between legal and physical manufacturer and the invoice issuer, an ISO 13485 certificate for the physical manufacturer with verification evidence, a CE or FDA quality assurance certificate for the legal manufacturer with verification evidence, and an EU Declaration of Conformity carrying the GMDN code. Conditional items are the EC Design Examination certificate or FDA CFG for class III / class D IVD, a porcine derivative free statement for animal tissue devices, and a classification letter for borderline products.

Similar device types manufactured at the same premises may be included in one application (e.g. all stents, all intra ocular lenses, all catheters), but an application may not cover more than 5 products; separate applications (and fees) are required beyond that and for separate premises.

A Device Master File (construction materials and quantitative analysis) is required only where CE or US FDA approvals are not available; where such approvals exist they serve as the primary evidence.

Applicants for registration and Marketing Authorization Certificates must present, on demand of the Licensing Authority, satisfactory information on the quality, safety and efficacy of the drug (including the device); clinical trial or bioequivalence study data may be required for specific products.

For foreign produced devices the dossier (Resolution 55, Appendix 1, section 2) includes: application; producer's information letter; registration/market authorization document from the country of manufacture (legalized/apostilled, notarized translation); QMS conformity certificate for the producer and, where needed, the production site; IFU/operation manual; full color labeling and packaging sample; shelf life report; and the producer's power of attorney (original or notarized copy).

Foreign documents for the dossier require legalization or apostille (unless an international treaty of Belarus provides otherwise) and a translation into Belarusian or Russian with notarized certification of the translation/translator's signature; the IFU translation may instead be certified by the producer with the note 'Перевод соответствует оригиналу'.

After a positive RUP CEIZ conclusion from the preliminary technical works, the applicant submits to the Ministry of Health: (1) an application and (2) the RUP CEIZ conformity conclusion; for limited quantity supplies also the supply contract, its specification and the contract with the healthcare organization or procurement organizer.

An application for a Belgian Free Sale Certificate must be supported by the manufacturer's EU declaration(s) of conformity and ISO 9000 / EN ISO 13485 certificates; for devices still under transition, proof of benefit from the transition period under Article 120 of Regulation 2017/745 (or Article 110 of Regulation 2017/746) must be provided.

statement: The legal administrative part of the device dossier comprises a photocopy of the ministerial or secretarial resolution authorising the company to operate, a photocopy of the current company certificate issued by the medicines and health technology directorate attesting the company's operating authorisation, annual re registration and inspection (manufacturer or importer), and a separate signed sheet giving the general licence and manufacturer information — the company granting the legal representation and its validity, the product owner or licensor, the manufacturer, the manufacturer(s) of the finished product and, for third party manufacture, the plants that manufacture, fill or pack the product, each with addresses, telephone numbers, fax and e mail. · article: Numerales 2.2.1 2.2.3

statement: The applicant must file the original or a copy legalised by a health authority — not necessarily consularised — of the quality system certification in use, being Good Manufacturing Practices or its equivalent, for every plant involved in manufacturing including conditioning or packing plants; the certificate must be no more than two years old. AGEMED may at any time require in situ verification of the plant or request information from the regulatory authority of the country of origin about the quality system, independently of the certificate filed. For ISO certificates, AGEMED accepts a simple copy in the dossier provided it is signed and sealed by the company's legal representative and pharmaceutical regent in Bolivia as an attestation of the document's veracity. · article: Numeral 2.3.1

statement: Submitting samples to AGEMED with the dossier is a requirement for the issuance of the registration for low risk medical devices. For moderate risk, moderate high risk and high risk devices, submitting a sample is not a requirement, although AGEMED may verify the products at any time in the company's or institution's warehouses. · article: Numeral 2.6

The registration dossier must include an insurance policy as proof of insurance of users against damage arising in the application of the medical device. The manufacturer or authorised representative must submit complete information on the manufacturer's liability insurance valid on the territory of Bosnia and Herzegovina. The Agency's applicant guidance requires the policy to be issued by an insurance company registered in Bosnia and Herzegovina and to be made out to the applicant, as an original or a municipal or notarised copy.

The registration dossier must include a quality system certificate (ISO certificate), except for class I medical devices. The Agency's applicant guidance specifies ISO 9001:2015 (quality management systems — requirements) and ISO 13485:2016 (medical devices — quality management systems — requirements for regulatory purposes).

For a class I, IIa, IIb or III medical device the registration dossier must contain, besides the class specific application form and Annex 1: proof of authorised representation of the manufacturer on the territory of BiH (representation contract or letter of authorisation, original or certified copy); the certificate of conformity with the directives and regulations of the European Union (CE marking certificate, EC certificate), except for class I devices, original or certified copy in the country of origin; the manufacturer's declaration of conformity against the European directive stating the exact class, original or certified copy in the country of origin; proof that the device is marketed in the manufacturer's country or in an EU member state; an insurance policy covering damage to users arising from the application of the device; certification of the quality system, except for class I devices; a certificate of conformity of sterile products and a description of the sterilisation method and sterility control tests for sterile devices; information on the device (composition, brief product description, declared purpose); details of the proposed shelf life and storage conditions; packaging, form, material and composition; instructions for use in a foreign language for foreign origin products and a proposed instruction in one of the official languages of BiH; confirmation of measuring conformity for devices with a measuring function; and proof of payment of the Agency's registration fee and the administrative charge.

For a Class B, C or D general medical device, BoMRA requires a separate and complete electronic dossier for each single device, family, system or group, arranged as: the application form on the online platform; letter of authorisation; proof of a quality management system such as an ISO 13485 certificate or equivalent; information on device details; summary technical documentation; labelling information; and the Essential Principles checklist. Failure to arrange the dossier in that order may lead to rejection at submission.

A registration application may contain only one grouping a single medical device, one device family, one device system, or one device group as prescribed in the Grouping guideline BOMRA/ER/MED/P04/G07, which applies to all medical devices including IVDs.

Registration dossiers follow the IMDRF Market Authorization Table of Contents (RDC 751/2022 Art. 57 and Anexo II); petitions with incomplete checklists or missing documents face summary refusal (indeferimento sumário).

AITI's Table 1 requires, for Dealer Type Approval, technical specifications and/or an equipment brochure and a picture of the equipment at Level 1, and additionally a test report or certificate of conformity for the equipment at Levels 2 and 3. For Levels 2 and 3 the declaration of conformity must rest on certification or test reports showing design and construction in accordance with international standards recognised by the Authority.

The Medicines Act prescribes no dossier for any product beyond s. 11(2), under which an application to register a medicinal product must be accompanied by the prescribed processing fee and 'such documents, items, samples, particulars and other information as the Authority may require', and s. 13, under which the Authority may require a manufacturer's declaration of compliance with the laws of the country of manufacture. No technical file, CSDT, STED or other device dossier requirement exists in Brunei law or Ministry of Health guidance.

The device registration application (ЗМИ Art. 27) must attach: the company unified identification code (ЕИК); the name and description of the device; and a document for the fee paid per the tariff.

The IVD registration application (ЗМИ Art. 28) must attach: ЕИК; technical and analytical characteristics; for List A/B and self testing devices also the name, type and model of the device and results of the performance evaluation; instructions for use in Bulgarian; and a document for the paid fee.

Technical documentation for a device submitted under the ASEAN framework must follow the ASEAN Common Submission Dossier Template (Annex 4 to the AMDD), which Member States are required to adopt and implement as a common technical document, together with the post marketing alert system (Annex 5) and the harmonised Declaration of Conformity elements (Annex 6).

Class II MDL application (s.32(2)): device name, identifier and class; conditions, purposes and uses of the device; an indication of the standards met in design and manufacture; a copy of the label and directions for use; and a certificate to CAN/CSA ISO 13485 issued by a recognized registrar, with an attestation that the manufacturer has objective evidence for the safety and effectiveness requirements.

Class III MDL application (s.32(3)) adds: a description of how the device works and the materials used; a list of the countries other than Canada where the device has been sold; summaries of all studies on safety and effectiveness; a bibliography of all reports; and the quality system certificate.

Class IV MDL application (s.32(4)) adds: a risk assessment comprising an analysis and evaluation of the risks; detailed information on all studies carried out to demonstrate safety and effectiveness; a quality program plan; details of manufacturing, packaging, sterilization, installation and servicing procedures; and the quality system certificate.

For portable automated external defibrillators (Decreto Exento 42/2021), the dossier additionally requires: IEC 60601 1, IEC 60601 2 4 and IEC 60601 1 2 compliance certificates; evidence of local post sale technical service; declaration of spare parts and accessory assurance; technical and/or user manual; risk management report and mitigation measures; biocompatibility report; operator/quick start guide.

Registration dossier (ficha 9100003) requires, as applicable to the device type: (1) certificate of verification of conformity and reports from an authorized national body (except defibrillators); (2) export or free sale certificate from the country's health authority, consularized or apostilled; (3) manufacturer's document recognizing the applicant as authorized representative/distributor (not for local manufacturers); (4) manufacturer's quality management system certificate (ISO 13485, ISO 9001 or equivalent), consularized or apostilled; (5) sterility certificates of declared lots, when applicable, consularized or apostilled; (6) draft label; (7) draft instructions for use; (19) supporting scientific literature; (20) studies in representative patient groups or clinical investigations.

NMPA Announcement No. 121 of 2021 prescribes the mandatory registration dossier requirements and the certificate/decision document formats, with separate annexes for first registration, change, renewal and clinical trial approval submissions; effective 2022 01 01, repealing the 2014 No. 43 formats.

Official documents issued abroad must be authenticated by the Colombian consul and the Ministry of Foreign Affairs or bear an apostille; documents not in Spanish require official translation; if the document states no validity period, it is deemed valid for one year.

For imported devices, the dossier additionally requires: (a) commercial history referencing countries where the device is sold and related alerts; (b) country of origin authorization or reference country free sale certificate; (c) proof of constitution, existence and legal representation of the titular, manufacturer and importer.

Article 18 lists the technical evaluation dossier for devices that are not controlled technology: form endorsed by the technical director (name, presentation, manufacturer, shelf life, classification, indications, ECRI/GMDN code, warnings), copy of quality system certification (CCAA or BPM or equivalent), device description, technical studies/test reports or certificate of analysis, sterilization and disposal methods, final label and insert artwork, free sale certificate; for classes IIa/IIb/III scientific information and risk analysis, and for classes IIb/III clinical studies.

Class 2 EMB registration requires: Regístrelo application form digitally signed; valid operating permit (national products) or Certificate of Free Sale (imported products, legalized/apostilled with official translation when not in Spanish, plus notarial certification); original technical and medical specifications, manuals and inserts as marketed (with translation if not Spanish); GMP certificate of the manufacturer or its equivalent in the country of origin (see QMS fact); radiation source authorization where applicable; original label (or complementary label project); manufacturing contract for contract manufacture; legal representative power; payment of the Decreto 32780 fee; for IVDs, a document identifying the applicable international accuracy/precision standard.

Class 3 EMB must additionally submit detailed clinical evidence demonstrating safety and efficacy: clinical evaluation document by the manufacturer; preclinical studies if applicable; clinical studies in humans (where the manufacturer conducted none due to well established technology, third party studies on the product or on a similar product with an equivalence declaration and supporting evidence are accepted); software validation study if applicable; bibliographic studies; and a risk analysis/evaluation summary. Class 3 IVDs may instead/also submit comparative performance studies on representative human samples under expected use conditions with a truthfulness declaration by the holder.

Class 4 EMB must additionally submit: copy of the risk analysis and evaluation study with risk reduction measures prepared by the manufacturer; bibliographic references of published post marketing reports on use, safety and efficacy; and, for devices made from animal tissues or derivatives, a manufacturer certificate demonstrating biological safety.

All registration documents must be in Spanish (official translation for legal/official documents; simple translation of the original labeling); every official/legal document issued abroad must be legalized or apostilled with a digitally signed notarial certification (or per Decreto 37988 S); all information has the character of a sworn declaration (declaración jurada); official certificates must be valid at submission and, where validity is not stated, are considered valid for 2 years from issuance; corrections in certifications are not allowed unless supported by the issuing authority.

The device marketing authorisation dossier has two parts. The administrative part, in hard copy, comprises: the application in four copies addressed to the AIRP Directeur Général, stating the manufacturer's name and registered office, the applicant's name and address, the manufacturer's representative where applicable, and the device's trade name, presentation, use, reference and UEMOA classification; a certified copy of the conformity attestation obtained under the international procedures recognised by the AIRP; a copy of any good manufacturing practice certificate in force for medical devices; a document attesting first placing on the market in the country of origin; a valid batch conformity certificate; an attestation of the wholesale ex tax price (PGHT) in three copies, in CFA francs, setting out the price structure (ex works or supplier ex tax price in the origin country, proposed PGHT in CFA francs, and the public retail price in both the origin country and Côte d'Ivoire); and proof of payment of the homologation fees. The technical part is filed electronically on CD ROM or DVD ROM and comprises stability study results where applicable, a risk management plan for the device across its life cycle, documentation with a checklist demonstrating conformity with the essential requirements and the corresponding standards, where necessary documentation indicating the requirements not applicable to the device, a summary of the device's technical characteristics/specifications in French, and the labelling model and instructions for use model.

For the national notification of placing a device on the market HALMED requires: the completed notification form — Obrazac MEDPRO II/III for Class IIa, IIb and III medical devices or Obrazac IVD MEDPRO for in vitro diagnostic medical devices; an Excel list of the products; the conformity certificate (EC certificate, with any supplement relating to Regulations (EU) 2023/607 and 2024/1860) and the EU declaration of conformity, in ZIP format; a labelling sample (box) and the instructions for use, in ZIP format; and proof of payment of the procedure fee. Products covered by the same EC certificate may be listed together and filed as one notification.

For Class IIb and III devices, the dossier must include a clinical evaluation report prepared from clinical data collected by the manufacturer to demonstrate safety and efficacy of the device for the requested application and medical specialty, per the regulation on presentation of clinical evidence for registration (Regulación E 79 15). Class IIb, III and novel devices require clinical evidence per the Proceso de Registro page.

For imported devices, the first requirement is presentation of the Certificate of Registration in the country of origin, or in a country whose regulatory program is based on the same essential requirements. Where the device is not subject to registration in the origin country, a manufacturer declaration to that effect plus evidence of circulation in that or another regulated market is accepted.

The registration dossier (acápite 3.2.2 and Anexo 2 of E 86 16) includes: a risk management report with an appropriately implemented risk management plan, acceptable overall residual risk and production/post production information methods (per ISO 14971); biological pre clinical evidence per ISO 10993 for implants, dental, reusable and single use devices and devices derived from biological substances; safety, environmental, parametric and metrological test reports for listed equipment categories; sterilization validation and sterilizer certificate where relevant; description of specifications and lot key; and label artwork/sample.

For the assessment and approval of a clinical investigation of a medical device, a fully completed application must be submitted to CYMDA, accompanied by all the necessary documents set out in Annex XV, Chapter II of Regulation (EU) 2017/745.

An operator placing medical devices on the Cypriot market notifies CYMDA by emailing the completed Excel notification file to cymda@mphs.moh.gov.cy. The current notification page links Notification of Medical Devices.xlsx. This page describes the notification submission; it does not establish an exemption from other technical documentation duties.

A manufacturer or authorised representative seated in the Czech Republic, or placing devices on the Czech market, must keep and submit to SÚKL on request all information and documentation necessary to demonstrate conformity in Czech, Slovak or English; the EU declaration of conformity for devices supplied to the Czech market must be issued in, or translated into, one of these three languages.

Documents required by the ethics committee for a clinical investigation or performance study must be submitted in Czech; the committee may allow another language, except for the informed consent form and the summary of the investigation/performance study plan.

Healthcare providers must keep documentation of servicing in Czech, Slovak or English for the whole period of device use and for a further 1 year after the device is decommissioned.

Until the EUDAMED clinical investigation portal is ready, sponsors apply directly to the authorities: the application (English language application form) with all documents is sent by e mail simultaneously to the Danish Medicines Agency and the Danish national/Regional Ethics Committees (De Videnskabsetiske Medicinske Komitéer), max 50 MB per e mail. The application may be in Danish or English, but participant information and consent material must be submitted in Danish. Documentation must follow MDR Annex XV, with MDCG guidance (MDCG 2021 6 rev 1, 2020 10, 2024 3, 2024 5) applied.

Documents submitted to the Danish Medicines Agency in applications for designation as a conformity assessment body (notified body) under MDR Articles 38 39 and IVDR Articles 34 35 must be drafted in English.

statement: The dossier for an imported sanitary product comprises: the registration application form; the representative establishment's current registration certificate; the notarised/apostilled power of representation; the manufacturing or packaging contract where applicable; a current ONAPI trade mark certificate where applicable; the origin country free sale certificate and the manufacturer's GMP or quality system certificate, legalised or apostilled; the manufacturing certification in maquila cases; proof of tax payment; a product description listing the main parts and, where applicable, qualitative quantitative composition, specifications, operation and descriptive information; plans or schematics of the product (for medical devices); for device families, a summary description of the family and the list of codes or products composing it; technical studies and analytical checks with a summary of design tests and specifications; the manufacturing method with flow chart, process description and controls; quality control methods signed by the quality control officer; an original certificate of analysis of the finished product covering physico chemical, microbiological, pyrogen and sterility testing as applicable, with lot number, manufacture and expiry dates and acceptance ranges, matched to the deposited samples and signed by the quality control officer; two original samples of the finished product with at least one year of validity; the disposal method where applicable; the professional use information including indications, warnings, precautions, contraindications and the product's risk level; the proposed package insert or instructions; proposed primary and secondary packaging; and the official technical sheet (DGDF RP FO 005) and professional information sheet (DGDF RP FO 007). · sourceApproval: none · targetJurisdictionId: dominican republic · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

Imported products must additionally file a Certificate of Free Sale (or equivalent) declaring commercialization, product names/codes, manufacturer and manufacturing sites, and a legalized authorization from the titular del producto empowering the applicant to obtain the Ecuadorian registration with express scope; documents without a stated validity are treated as valid for a maximum of two years from issuance.

Technical documents for registration, modification or re registration must be in Spanish or English and must be listed in a letter electronically signed by the responsable técnico in Ecuador; the electronic signature must allow authenticity validation under Art. 15 of the Ley de Comercio Electrónico. Labels must be attached as PDF originals (no scans/copies).

Legal documents issued by foreign authorities must be apostilled or consularized (Hague Convention) and presented in Spanish or English; translations by a certified translator are required for other languages. The 2026 norm accepts foreign legal documents without apostille when their content can be verified on the issuing authority's official web portal (with an e signed letter providing the link), and requires apostille when online verification is not possible.

The dossier must contain, per device type and risk level: batch/serial code explanation and draft labels (all classes), Spanish insert/manual, functional description of components (electromedical/lab equipment), raw material and packaging descriptions, manufacturing flow diagram, stability study (products with expiry), sterility certificate (sterile devices), manufacturer quality certificate, plus safety/efficacy evidence (biocompatibility, biofunctionality, clinical or SaMD evaluation, IVD performance studies) as triggered by type and class.

The dossier requires a CE certificate of the finished product issued by a notified body (with EU 722/2012 TSE annotation where bovine material is used), an ISO 13485:2016 or EN ISO 13485:2016 certificate from an internationally accredited certification body covering the product category, and a stamped/signed Declaration of Conformity. A CE certificate is not required for Class I non sterile devices, which instead submit a compliance with essential requirements and harmonized standards checklist.

Uploaded documents must be original, stamped with the company's official stamp and signed by the legal representative (scans or electronic signature accepted); the file includes technical file contents on manufacturer letterhead (composition, analysis certificate, sterilization certificate, packaging), inner/outer label data with Master Label samples and artwork, the original IFU signed and stamped by the manufacturer, shelf life certificate, previous license for re registration, and a device sample.

Foreign certificates from reference countries must be legalized by the Chamber of Commerce and the Egyptian Embassy in the country of origin unless EDA verifies their authenticity directly with the issuing bodies; if the issuing body does not respond within 3 months of file receipt, the file is saved and must be resubmitted with legalization.

For devices imported from non reference countries in all classes (I, IIa, IIb and III), the applicant must provide clinical trials published in reputable scientific journals and an approved, stamped summary of market history from centers/hospitals in reference countries where the device was used, plus material composition certificate, catalog/leaflet with intended use and inner/outer labels.

The national addition to the dossier regime is a retention and availability duty. Under § 25 of the Medical Devices Act the manufacturer or its authorised representative must keep device related documents available to Ravimiamet for the following periods: at least ten or 15 years, as provided in Article 8 of Chapter III of Annex IX, Article 7 of Annex X, Articles 9 and 10.5 of Part A of Annex XI, Articles 17 and 18.4 of Part B of Annex XI and Article 4 of Annex XIII to Regulation (EU) 2017/745; and at least ten years, as provided in Article 7 of Chapter III of Annex IX, Article 6 of Annex X and Article 6 of Annex XI to Regulation (EU) 2017/746. § 2(1) of the same Act channels the national general layer: the obligations of the manufacturer, its authorised representative, the importer and the distributor, the notified body, conformity assessment of medical devices and market surveillance are subject to the requirements of the Product Conformity Act, with the derogations arising from the Medical Devices Act and from Regulations (EU) 2017/745 and (EU) 2017/746. The Estonian regime therefore does not add dossier content to the Union technical documentation; it adds who must hold it, for how long, and in what form of availability to the national authority.

Estonia is a Member State of the European Union and applies Regulation (EU) 2017/745 and Regulation (EU) 2017/746 directly, so the device dossier is the technical documentation those Regulations require rather than a national dossier compiled for Ravimiamet. Under Article 10(4) MDR, manufacturers of devices other than custom made devices must draw up and keep up to date technical documentation for those devices, such as to allow the conformity of the device with the requirements of the Regulation to be assessed, including the elements set out in Annexes II and III; for custom made devices the documentation is that of Annex XIII Section 2. Article 10(8) requires the manufacturer to keep the technical documentation, the EU declaration of conformity and, where applicable, a copy of any relevant notified body certificate available to the competent authorities for at least 10 years after the last device covered by the declaration of conformity has been placed on the market, or at least 15 years for implantable devices, and to provide the technical documentation in its entirety or a summary on request by a competent authority. Annex II sets out the technical documentation contents, beginning with device description and specification, including variants and accessories.

The non IVD registration dossier (GDL/097) is filed in two parts. The administrative chapter requires a stamped and signed cover letter, the agency agreement, evidence of the registration application fee, a valid ISO 13485 or CE full quality system certificate covering the manufacturing sites and products, a GMP certificate for applicable high risk devices, an original and valid free sale / marketing authorisation certificate, a risk free TSE/BSE attestation and a declaration of conformity against the essential principles, classification rules and conformity assessment procedure. The technical chapters cover the general summary of submission, device description and principles of operation, packaging, development history, comparison with similar or previous generations, substantial equivalence, indications and contraindications, global market history including incidents and recalls, and the evidence for conformity with the essential principles. All attached data and documents must be in English and submitted as PDF through eRIS.

Once compliance is demonstrated via the applicable conformity assessment procedure, manufacturers (other than custom made or investigational) must draw up an EU declaration of conformity stating that the Regulation's requirements are fulfilled, containing at minimum the Annex IV information (manufacturer/AR identification incl. SRN where issued, Basic UDI DI, device identification, harmonised standards/CS applied, signature), keep it continuously updated, translated into the official Union language(s) required by the Member State(s), and affix the CE marking (Art. 10(6), Art. 19(1), Annex IV MDR).

Technical documentation, the EU declaration of conformity and copies of certificates must be kept available for competent authorities for at least 10 years after the last device covered by the EU declaration of conformity has been placed on the market; for implantable devices, at least 15 years after the last device has been placed on the market (Art. 10(8) MDR).

Manufacturers of devices other than custom made must draw up and keep up to date technical documentation allowing assessment of conformity, including the elements of Annexes II and III (device description incl. Basic UDI DI, GSPR compliance, benefit risk analysis and risk management, clinical evaluation and PMCF, PMS system content, post market surveillance plan); Annex II requires presentation in a clear, organised, readily searchable and unambiguous manner (Art. 10(4) MDR).

Notifications to Fimea must include the operator's name, place of business and other necessary contact details; manufacturers, custom made device manufacturers and importers must list the devices they intend to place on the market with risk class, intended purpose, operating principle and identification data; manufacturers and importers must supply a copy of the notified body certificate; manufacturers must state their authorised representative where applicable.

The technical documentation required to demonstrate conformity with the general safety and performance requirements must be drawn up in accordance with Annex II to Regulation (EU) 2017/745 (device description and general information, information supplied by the manufacturer, information on design and manufacture, general safety and performance requirements, benefit risk analysis and risk management, product verification and validation) together with the post market surveillance technical documentation of Annex III, and kept available to the competent authorities.

To register a medical device clinical investigation the applicant files with the Agency: an application in the form set by the Agency together with a receipt for the registration fee; the original, apostilled/legalised and notarised document delegating the sponsor's authority, with a notarised Georgian translation; the clinical investigation plan and protocol drawn up to GCP standards with a notarised Georgian translation; the subject information sheet and written informed consent form with a notarised Georgian translation; the case report form in English in electronic form; the original risk/responsibility insurance document signed by the sponsor or its authorised person and by an insurance company registered in Georgia; evidence of manufacture to the relevant standard; written consents of the directors and clinical managers of the participating medical institutions; reasoned positive opinions of each institution's local independent ethics committee; and the investigator's CV, licence certificates, GCP training certificate and investigator's brochure.

For a contraceptive mechanical device (other than a non invasive one) the scientific and technical part of the dossier is: the name and address of the manufacturer; a standard determining the quality criteria; and 2 samples accompanied by a certificate of quality. For a dental product: name, composition, component data and designation; a standard determining the quality criteria; a certificate of quality; safety data; and a sample. For diagnostic products — test systems (by nosology), allergens (other than allergens designated for an individual natural person), reagents for clinical biochemistry and chemistry, and sera: designation and method of use, a list with the manufacturing company's catalogue number and/or catalogue; safety and efficacy data for in vivo use; and quality assessment criteria plus stability data if necessary.

In Germany, free sale certificates (Freiverkaufszertifikate / certificates of free marketability) are issued only by the competent Landesbehörde (state authority) on application by a manufacturer or EU authorised representative, on the basis of MDR Art. 60 / IVDR Art. 55; BfArM does not issue them, and this continues to apply when product registration runs via EUDAMED.

A certified copy is a true copy of the original certified by a person registered to practise law in the manufacturer's country of origin, endorsed with the legal practitioner's official stamp and signature.

All applications and supporting documents must be in English; non English reports are not accepted alone. Non English material must be submitted in the original language with a full English translation, authenticated at the nearest Ghana Embassy or by the National Drug Regulatory Authority of the country of origin.

The dossier must include Summary Technical Documentation demonstrating conformity to the Essential Principles of Safety and Performance, covering device verification and validation, biocompatibility, software validation, pre clinical studies, clinical evidence (if applicable) and risk analysis.

A new registration application comprises one original hard copy and one electronic copy (text selectable PDF on CD ROM), samples of the product per the FDA sample schedule, and the non refundable application fee per the FDA Fee Schedule.

Dossier for registration (new, supplementary or renewal) in the EOF Manufacturers' Register: business licence (Άδεια Ασκήσεως Επαγγέλματος), company legalization documents, Declaration of Conformity, and the Bank of Greece fee (παράβολο). The technical file of the product remains at the company's premises, at EOF's disposal; all forms are submitted with original signatures and company stamp.

The device inscription dossier is a closed list of thirteen items: proof of fee payment for the inscription procedure, which also covers sanitary surveillance; the F AS f 08 application signed, sealed and stamped by a Químico Farmacéutico; finished product specifications in Spanish; a product description in Spanish; the origin country Certificate of Free Sale; a GMP certificate or other equivalent sanitary norm; an authenticated copy of the manufacturer's power of representation; analytical methodology where applicable; a quality control certificate issued by the manufacturing laboratory; original primary and/or secondary packaging or readable drafts, with photocopies and overlaid labels not accepted; sealed samples according to the National Health Laboratory quantity list where applicable; technical literature, catalogue or insert in Spanish where applicable; and a photocopy of the registering establishment's sanitary licence.

Core documents: manufacturer's letter designating the LRP; valid Hong Kong Business Registration Certificate; CAB Conformity Assessment Certificate (Pathway 1) or marketing approval documents (Pathway 2); ISO 13485 certificate or equivalent; Essential Principles Conformity Checklist/Declaration; Clinical Evaluation Report (GMD) or Performance Evaluation Report (IVDMD); device labelling; and relevant Hong Kong licences (e.g. under Radiation Ordinance Cap. 303).

All documents must be submitted in Simplified Chinese, Traditional Chinese or English; other language documents need an English or Chinese translation, with both original and translation submitted; translation accuracy must be demonstrated on request (e.g. ISO 17100 certification or notary public evidence).

Where applicable, copies of licences under the Radiation Ordinance (Cap 303), Pharmacy and Poisons Ordinance (Cap 138), Antibiotics Ordinance (Cap 137), Dangerous Drugs Ordinance (Cap 134) or Telecommunications Ordinance (Cap 106) must be submitted (e.g. Irradiating Apparatus Licence, Wholesale Dealer Licence).

Clinical investigation applications follow an official checklist of roughly 30 documents aligned with MDCG 2021 08 and MDCG 2021 28, submitted via e ügyintézés with the SRN stated; the instructions for use must be supplied in Hungarian and in the original English.

The distributor notification under 17. § (3) must attach the device's Hungarian and English instructions for use, the EU declaration of conformity, the certificate where conformity assessment requires one, and a registration certificate where the manufacturer is not yet registered in EUDAMED.

EUDAMED Actor registration requires uploading a declaration named 'Declaration on Information Security Responsibilities', the LAA designation documents, and for non EU manufacturers an extract of the authorised representative contract.

The documentation that matters for Iceland is the Union package. The manufacturer must issue an EU declaration of conformity under Annex IV of Regulation (EU) 2017/745, and the device must be accompanied by the required information under Annex I Chapter III point 23 of that Regulation, including the manufacturer's name and registered address, the device name, package contents and intended purpose, the batch or serial number, and shelf life and storage conditions where applicable. Lyfjastofnun's guidance lists these items as examples and states the list is not exhaustive.

Iceland has no national dossier submission. The manufacturer (other than of custom made devices) must draw up technical documentation and keep it up to date; the documentation must allow the conformity of the device with the Act and the Regulations to be assessed and must cover the matters set out in Annexes II and III of the Regulations. The file is kept by the manufacturer, not filed with Lyfjastofnun; the authority's power is to require it to be produced on request. A registration manager therefore does not file a technical file in Iceland.

Import licence applications require: notarised overseas plant registration and free sale certificate from the country of origin; notarised QMS certificate (or Full/Production Quality Assurance certificate); self attested Indian wholesale or manufacturing licence; and a copy of the latest inspection/audit report by a notified body or authority within the last three years.

The overseas manufacturer's power of attorney in favour of the Indian authorised agent must be authenticated in India either by a first class Magistrate, or by the Indian Embassy in the country of origin, or by an equivalent authority through apostille.

For new, extension, variation and extension with variation import applications: valid Izin DAK covering the product group; agency appointment letter (surat penunjukan keagenan) from the manufacturer/principal legalized by the Indonesian government representative in the origin country, valid max 5 years; valid CFS from the origin country authority; stamped declaration of willingness to relinquish the agency; trademark certificate for OEM imports; stamped statement of document authenticity; integrity pact; PNBP payment (non refundable). New applications must additionally submit SOPs for complaint handling, adverse events, product recall and other post market product information.

Technical dossier for import classes A D must include an ISO 13485 certificate (latest edition) from an accredited certification body naming the manufacturer as on the CFS, with scope covering the device type; where devices are not regulated in the manufacturer's country, ISO 9001 is accepted; a CE certificate must be included if a numbered CE mark is on the labelling; plus the manufacturer's Declaration of Conformity against the standards used (SNI, ISO, pharmacopoeia etc.). Domestic applications accept SNI ISO 9001/ISO 9001 and/or SNI ISO 13485/ISO 13485, CE certificate if CE marked, and a CPAKB (device GMP) certificate where already held.

Dossier for a class A/B پروانه ساخت: company articles (اساسنامه شرکت); technical officer credential; technical file per the issuance/renewal directive; commitment to prepare and retain the technical file; safety and performance test reports from the directorate's cooperating laboratories; suitable production environment; QMS implementation evidenced by an ISO 13485 certificate.

Pharmaceutical company and manufacturing site registration files with MOH include, among other documents, a GMP certificate, a manufacturing licence, a Site Master File and a boycott declaration (اقرار مقاطعة مع اسرائيل).

For goods supplied from outside Iraq under the MOP standard contract, the supplier must deliver with the shipment: signed and stamped invoice; transport document to final destination; packing lists; insurance certificate showing the Purchaser as beneficiary; one original manufacturer's or supplier's warranty certificate covering all items supplied; certificate of origin endorsed by the relevant Iraqi commercial agencies abroad; and, where inspection is required, the original Certificate of Inspection from the nominated inspection agency.

The technical documentation required to demonstrate conformity with the general safety and performance requirements must be drawn up in accordance with Annex II to Regulation (EU) 2017/745 (device description and general information, information supplied by the manufacturer, information on design and manufacture, general safety and performance requirements, benefit risk analysis and risk management, product verification and validation) together with the post market surveillance technical documentation of Annex III, and kept available to the competent authorities.

A single application must not combine: a drug device combination product with a device that does not contain a drug; implants with non implants; a product of animal/biological origin with a product that is not of that origin; ionizing radiation emitting equipment with non ionizing equipment; or a device intended for a professional user with a device intended for a lay user.

AMAR approval is for finished products only. The application consists of an electronic form (site 'forms' category) plus scanned attachments; separate applications are required per device family/class, and separately for implants, biological products, radiation emitting devices and different user types.

For Class IIb (or FDA Class II) or Class III products, the application must include the risk analysis summary as filed with the approving authority and a summary of the clinical trials file. A local manufacturer without recognized state approvals (Class IIb/III) must additionally attach a risk analysis, a clinical trials file and an opinion from a senior medical figure holding an Israeli practice licence.

Each registration application may include only one of: a single product; a family of products, provided every product has the same risk class; a system whose parts are used together; or a procedure pack of products from the same manufacturer. Models included in the application must be listed on the registration form.

Accepted reference approvals: US FDA; Europe CE plus Declaration of Conformity (Class 1 self declaration accepted, except sterile/measuring devices which need notified body CE and a split application); Australia NZ TGA of the REGISTRATION type only; Health Canada. An application filed with an expired approval is rejected on the spot; all approval dates must be entered DD/MM/YYYY.

All documents for MDR Art. 52 conformity assessment procedures (including technical documentation and audit/evaluation/inspection reports) must be drafted in Italian or in another EU language accepted by the notified body; a notified body established in Italy must, on Ministry request, provide that documentation translated into Italian by sworn translation (perizia giurata).

A notified body established in Italy must draft the documents indicated in MDR Arts. 38 and 39 (application for designation and designation documentation) in Italian.

Nonclinical safety data must meet device GLP Ordinance No. 37/2005 and clinical trial data device GCP Ordinance No. 36/2005 (both 2005 MHLW Ordinances), plus data integrity requirements (accurate creation; handling of unfavorable findings).

Device approval dossier (Rule Art. 114 19) comprises: development history incl. foreign use status; design and development verification; conformity to Art. 41(3) standards; risk management; manufacturing method; clinical trial results or MHLW accepted substitutes (incl. documentation analyzed from real world clinical data); postmarket survey plan (PMSP Ordinance 38/2005); and safety information/labeling documentation. Application on form 様式第六十三の八 with MAH license copy (Rule Art. 114 17).

A submitted sample (defined as the final product including inner and outer packaging and the accompanying leaflet) must conform to the specifications in the technical file for secondary packaging materials; a non conforming sample is referred to the committee for decision even if it passed testing.

The EAEU registration dossier includes a copy of the certificate of conformity of the quality management system to ISO 13485 or an equivalent regional or national (state) standard of an EAEU member state.

EAEU registration dossier documents are submitted in Russian in electronic form; documents in a foreign language must be accompanied by a Russian translation certified per the reference state's law; if a reference state's law does not allow electronic form, paper copies with electronic copies are accepted.

The dossier submitted to the expert organization must contain the documents per Kazakhstani law as well as samples of the device.

Product registration applications for medical devices submitted to PPB must be prepared in the Common Submission Dossier Template (CSDT) format, which is based on the IMDRF STED guidance; administrative information must include the Local Representative Person details domiciled in Kenya.

Applicants must provide sales, complaints and vigilance data for the last five years, including full details of vigilance issues and the status of any Field Safety Corrective Actions or Notices.

statement: In the notification procedure the State Agency of Medicines checks the EU declaration of conformity and the certificates issued by notified bodies for conformity with the national regulation, Regulation (EU) 2017/745 and directly applicable EU acts, and against the information stated in the notification form. Where the submitted information does not conform or documents are missing, the agency asks the applicant to submit corrections or supplements. The agency may require translations of the documents submitted. · sourceApproval: · targetJurisdictionId: · edgeType: · marketAccessStrength: · regulatoryLayer: · localApplicationRequired: Yes · targetDecisionRetained: Yes

The registration application is drawn up in two copies and must include: (1) the LNDM identification sheet printed by the supplier from the MOPH computerised system, (2) at least one of the accepted conformity documents, (3) the packaging label, (4) the device's user manual and (5) the manufacturer's invoice. All documents required by the procedure must be supplied in one of three languages: English, French or Arabic.

Technical documentation, information and documentation per MDR Art. 10(14), Art. 11(3)(d) and Art. 41, the EU declaration of conformity (MDR Art. 19(1)) and the EU certificate (MDR Art. 56(1)) must be drawn up in German or English in Liechtenstein (EWR MepV Art. 10(4)). EWR IvDV Art. 11(4) sets the same German or English requirement for the corresponding IVDR documents (Art. 10(13), 11(3)(d), 37, 17(1), 51(1) IVDR).

On request of VASPVT (performing state supervision of medical devices), the manufacturer (or authorised representative, assembler/steriliser of systems and packs) must submit, in the Lithuanian state language, documents proving the devices' conformity with Regulation (EU) 2017/745 or Regulation (EU) 2017/746, together with copies of the technical documentation certified as prescribed by law.

During registration verification the Direction de la santé may request, depending on operator type (manufacturer MF / authorised representative AR / importer IM / system procedure pack producer PR): declaration of conformity; conformity certificates; QMS certificate; labelling; IFU; PRRC qualifications (Art. 15 MDR/IVDR); mandate/contract manufacturer AR; designation of devices to be imported; confirmation of manufacturer's and AR's EUDAMED registration; declaration per MDR Art. 22(1).

Filing applications use the same dedicated form and require: legitimacy declaration; criminal record and tax clearance documents; optional risk analysis (mandatory for IIa per gov.mo service page); technical requirements; label/IFU samples; overseas marketing authorization document (except designated regions); patent proof or declaration.

Registration applications use an ISAF dedicated form plus: applicant identity documents, criminal record certificates and tax clearance certificate; legitimacy declaration; risk analysis; essential principles safety and performance checklist; technical requirements; test summary report from the manufacturing plant or a third party testing institution; clinical evaluation and non clinical evaluation data; label/IFU samples; manufacturing site conformity proof (and contract manufacturing documents); overseas marketing authorization document for foreign made devices (except designated regions); optional third party review report for innovative devices; patent certificate or declaration.

Conformity assessment for registration comprises four elements: (a) quality management system, (b) post market surveillance system, (c) technical documentation, and (d) declaration of conformity; the CAB issues an assessment report and certificate that must be submitted with the registration application.

The registration dossier requires a Declaration of Conformity in the Appendix 3 (Third Schedule) format on manufacturer letterhead signed by top management; a QMS certificate (ISO 13485 or other acceptable QMS); for active devices electrical safety/EMC evidence (IEC 60601 1 series); and a post market surveillance summary covering reportable adverse events and field corrective actions for the past 3 years; for re registration, an updated DoC, updated PMS and a declaration of no change over the last 5 years if applicable.

Evidence of conformity is compiled per the Common Submission Dossier Template (CSDT) prescribed in Appendix 2 of the Third Schedule of MDR 2012; the CSDT shall be prepared in Bahasa Malaysia or English, and English and/or Bahasa Malaysia are the only acceptable languages for submissions and correspondence.

The documents submitted with a Maltese medical device notification are the device notification sheet, the Declaration of Conformity (DoC) and proof of payment. The notification sheet must list each device being made available on the local market — including variants — with the source country supplier, the product brand name, generic name, catalogue number, device type and class as written on the DoC, and, where applicable, the Basic UDI DI and UDI DI. The Authority may require any additional document relevant to the function of the organisation or the device. Every field must be completed, with 'N/A' where a section does not apply.

For foreign made devices, the application additionally requires: (I) certificate of free sale or equivalent issued by the health authority of the country of origin; (II) manufacturer's representation letter when the applicant is not the manufacturing headquarters; (III) GMP certificate issued by the health authority of the country of origin; (IV) original certificate of analysis on the manufacturer's letterhead signed by its responsible chemists.

Documents accompanying RIS applications must be drafted in Spanish or English; documents issued by foreign authorities must be apostilled or legalized, and documents in any other language must be accompanied by a translation by a certified expert translator (perito traductor with cédula profesional). Representation letters presented for import or registration must be authenticated by the applicable legal procedure.

RIS Art. 179 requires, with the official format application: (I) scientific/technical information demonstrating safety and efficacy; (II) Spanish language label draft per the applicable NOM; (III) Spanish IFU or operation manual when applicable; (IV) manufacturing process description; (V) structure, materials, parts and functions for equipos médicos; (VI) GMP certificate (constancia de buenas prácticas de fabricación); (VII) laboratory tests verifying specifications; (VIII) bibliographic references; (IX) others set in NOMs.

The applicant is liable for the veracity of the information and the correspondence of the documents presented, in accordance with the law. By finalising the dossier the delegated responsible person confirms by electronic signature that all data and documents in the dossier are authentic, complete and compliant with legal requirements. Submitting false information or falsified documents attracts liability under the law, including under art. 3521 of the Criminal Code of the Republic of Moldova. Presenting erroneous data or documents containing elements that do not attest to the veracity of the acts is an express ground for rejection, and in that case AMDM notifies the competent bodies under the law.

All dossier documents are filed in PDF, legible and complete, each file not exceeding 30 MB, and are electronically signed by the delegated responsible person, except the authorised representation agreement, which is signed by its parties. Each document must be named according to the type of document selected, following the table in the Procedure; where a dossier contains several documents of the same type they are differentiated by consecutive numbering added to the standard file name. The device name is entered in Romanian, preserving in their original form the trade names, marks, product codes, acronyms and other identification elements assigned by the manufacturer, and the remaining fields are completed in accordance with the declaration of conformity.

For the CE route the mandatory documents are, within the meaning of art. 7 alin. (3) of Legea nr. 102/2017: the declaration of conformity issued by the manufacturer in Romanian or English; the valid CE/EU certificate, for the risk classes for which the legislation requires the involvement of a notified body; and the act by which the manufacturer designates its authorised representative. The declaration of conformity and the CE/EU certificate are the only conformity documents listed; the representative designation act is filed under the manufacturer registration chapter. The absence of the CE/EU declaration of conformity and the absence of the CE/EU certificate, for the risk classes for which it is necessary, are express rejection grounds.

Beyond the mandatory documents, the applicant may file on its own initiative or at AMDM's reasoned request made during the examination the EN ISO 13485 certificate, the application for publication of the documents in the RSDM, images of the medical device, the manufacturer's catalogue or brochure, the primary, secondary and collective labels, the instructions for use, the service manual and the technical documentation.

Entry of medical equipment on the medical device list requires twelve documents, including a copy of the ISO 13485 certificate, the product's marketing authorisation or free sales certificate, the instructions for use with a Mongolian translation, software validation, a verification report, and the manufacturer's original letter designating the Mongolian supplying organisation. The consumables listing dossier requires ten documents, including the same marketing authorisation or free sales certificate and the Mongolian translated instructions for use.

The IVD registration dossier comprises an applicant's request; an introduction to the factory; a copy of the ISO 13485 certificate; evidence that the product falls within the 'laboratory diagnostic device' classification in its country of origin; quality, description, performance and stability data; laboratory test results and prototype test results; clinical evaluation and study results; the instructions for use for medical specialists together with a Mongolian copy; packaging artwork and samples; and accredited laboratory results where required.

statement: An application to register (or to renew the registration of) a medical device is filed on the prescribed form together with: (1) the number of the registration decision of a manufacturer that has no seat, residence or habitual residence in Montenegro; (2) the declaration of conformity; (3) the conformity certificate; (4) an insurance policy against harmful consequences that may arise from use of the device; (5) the original instructions for use issued by the manufacturer in English, together with a translation into Montenegrin and the languages in official use in Montenegro, certified by a doctor of medicine or of dentistry of the appropriate speciality; (6) the proposed outer packaging and label for Montenegro; and (7) any other documentation the Institute requests under the Law. Class I (general medical devices), the remaining in vitro diagnostic medical devices, and class A in vitro diagnostic medical devices are exempt from the conformity certificate. For manufacturers outside the European Union a free sale certificate, or a certificate issued by a body authorised for ISO 13485, is additionally filed. Documentation is filed on paper or electronically, in Montenegrin or English, in the original or as a copy signed or certified in accordance with the law. On a renewal application the documentation already filed at registration need not be resubmitted if it has not changed, in which case the applicant files the manufacturer's statement that the documentation is unchanged. · classIAndSomeIvdExemption: Class I (general medical devices), other in vitro diagnostic medical devices, and class A in vitro diagnostic medical devices: no conformity certificate is filed. · nonEuManufacturers: For manufacturers outside the European Union, in addition to the above, a free sale certificate or a certificate issued by a body authorised for ISO 13485 is filed. · renewalDelta: On renewal, unchanged documentation already filed at registration need not be resubmitted; the applicant instead files the manufacturer's statement that the documentation is unchanged.

The registration dossier is a fixed 17 item paper file: application letter in triplicate; fiche signalétique in triplicate; manufacturer's attestation evidencing the manufacturer–applicant link; the origin country CE/FDA/CVL certificate; ISO 13485 certificate for classes IIA, IIB and III; the manufacturer's declaration of conformity to the essential requirements; draft labelling; draft instructions for use where applicable; a sale model sample or prototype with colour photographs; technical documentation with a conformity checklist and the standards relied on; a descriptive note for medical equipment; the instructions for use or user manual; technical documentation under art. 5 of arrêté 2855 15 for medical equipment; a colour catalogue; the GMP certificate issued by the Direction du Médicament et de la Pharmacie; the completed registration certificate model (Annex II of arrêté 2855 15); and a copy of the declaration attestation of the Moroccan establishment. An electronic copy is also filed, with files generated by the automated module supplied by the AMMPS.

Class A (low risk) import recommendation applications require: cover letter; letter of authorization from owner or manufacturer; product description (if necessary); manufacturing licence or GMP certificate copy; ISO 13485 certificate copy; complete labeling information; copy of local business licence or certificate of incorporation.

Class B (low medium risk) import recommendation applications require: cover letter; LOA; product description (if necessary); manufacturing licence/GMP/EC certificate; ISO 13485 certificate copy; certificate of analysis or declaration of conformity including compliance standard; declaration of product safety; manufacturing process; evidence of marketing approval; risk analysis and risk management report; complete labeling information; local business licence/incorporation copy.

Class C and D import recommendation applications require 13 items: cover letter; LOA; product description; manufacturing licence or GMP certificate copy/EC certificate; ISO 13485 certificate copy; certificate of analysis/declaration of conformity including compliance standard; risk analysis and risk management report; clinical evaluation report; declaration of product safety; manufacturing process; evidence of marketing approval; complete labeling information; local business licence/incorporation copy.

Both the dossier and product samples must be submitted for medical device import applications; dossier requirements are published on www.fda.gov.mm.

The technical documentation required to demonstrate conformity with the general safety and performance requirements must be drawn up in accordance with Annex II to Regulation (EU) 2017/745 (device description and general information, information supplied by the manufacturer, information on design and manufacture, general safety and performance requirements, benefit risk analysis and risk management, product verification and validation) together with the post market surveillance technical documentation of Annex III, and kept available to the competent authorities.

With each notification the sponsor (or an employee) must provide a declaration that: the product is a medical device and is correctly classified under the regulations; the sponsor will only recommend the device for its intended purpose; and the information supplied is accurate and complete.

Information required per non exempt device (reg 5): the risk classification; names of manufacturer and sponsor with their registered office/principal place addresses and a contact phone or email; and the product description attributed by the Global Medical Device Nomenclature System (GMDNS). For Class III and Class AIMD devices a unique product identifier (trade or brand name, combined if required with a form of product identification) must also be entered. Same kind Class I/IIa/IIb devices from one manufacturer with the same GMDNS code and class may be notified as a single entry.

A comprehensive Certificate of Analysis on the QC laboratory's letterhead must accompany the application, stating brand name, batch number, manufacturing and expiry dates, and analyst name, designation and signature.

For imported devices, a Certificate of Manufacture and Free Sale issued by the relevant health/regulatory body in the country of manufacture must be authenticated by the Nigerian Embassy or High Commission in the country of origin; Commonwealth or ECOWAS countries may authenticate in countries without a Nigerian Embassy.

A product dossier in the NAFDAC IMDRF Table of Contents format is required: IVD ToC applicable to IVD Classes C and D, and nIVD ToC applicable to non IVD Classes C and D; all technical documents must be submitted in electronic format and originals presented upon request.

For imported devices, a Notarized Declaration (Appendix 1 of the registration guideline) must be completed typed, signed by the declarant, and notarized by a Notary Public in Nigeria.

For Class C and D devices (incl. IVDs), the applicant must notify the Directorate of the submission by email at md.vbmrr@nafdac.gov.ng stating the application number, to progress the dossier to full review.

The dossier must include evidence of the manufacturer's quality management system certification and a written Declaration of Conformity stating compliance with the Essential Principles of Safety and Performance, classification per the rules, and conformity assessment completion; a GMDN code/term (where available) and a certificate of compliance with recognized standards (where available) are included.

An application to register a medical device is filed on the class specific form and contains a cover letter, data on the applicant and the manufacturer, a certificate of the insurance policy together with a statement, the documentation prescribed by Article 7 for devices holding an EC certificate or by Article 8 for devices without one, and proof that the registration fee has been paid. The Agency may require samples of the device to be submitted with the application.

Where the device holds an EC certificate of conformity the dossier contains six items: the manufacturer's declaration of conformity, the EC certificate (except for class I devices and general IVDs), the EN ISO 13485 quality system certificate, the free sale certificate from the manufacturer's country, the insurance policy with statement, and the representation contract (or proof of branch / trade representation status). Where the device has no EC certificate the dossier must additionally contain the administrative data and the full quality, safety and efficacy data, a risk analysis for classes IIb, III and AIMD and for List A and List B IVDs, and, for classes IIa, IIb and III, clinical data or published literature or clinical investigation results on the basis of which the Agency obtains an expert opinion on the efficacy of the device.

On the non EC route the administrative data block of the dossier under Article 8 identifies the device by its classification under the international nomenclature for medical devices (GMDN or EDMA code) in addition to the applicant's and manufacturer's names and addresses, the free sale certificate, insurance and representation contract. The Article 7 dossier for devices holding an EC certificate does not require the code; the application forms instead carry a twelve item national device category code (section IV of the forms).

On request from Direktoratet for medisinske produkter, the manufacturer and the authorised representative must present all information and documentation necessary to demonstrate the device's conformity, in Norwegian or English.

The IVD Class C&D dossier mirrors the medical device structure: Class D (Annex II List A) requires all sections; Class C (Annex II List A moderate high risk) all sections except 5 and 6; Section 8 for IVDs covers clinical performance, analytical performance, stability and shelf life testing and software validation.

The Class C&D dossier follows a CSDT style structure of 12 sections (application type, manufacturer information, device information, labeling, essential principles, design V&V summary, product V&V, clinical evidence, post market control, distribution status, declaration of conformity, benefit risk analysis); Class D requires all sections, Class C all except sections 5 and 6.

Under the second proviso to rule 52(1), during the transitional exemption window (expiring 31 December 2022 per the exemption table), imported consignments of licensed importers and manufacturers could be released by Pakistan Customs on submission of notarized ISO 13485 and a notarized letter of authorization from the foreign manufacturer, plus one of: notarized free sale certificate from country of origin, notarized declaration of conformity from the foreign manufacturer, or notarized production or full quality assurance certificate (CE marking certificate) from a conformity assessment body.

Pending draft reglamento (NOT in force): every document filed for the issuance of a device Certificado de Registro Sanitario must be current at the moment of filing with a minimum of thirty working days of remaining validity. This is a filing window rule that also applies to IVDs, whose CLV, if undated as to expiry, is treated as valid for two years (draft Art. 123).

Pending draft reglamento (NOT in force): the application for a Certificado de Registro Sanitario for a Class B, C or D medical device must be filed with a defined set of documents — the application form signed by the legal representative or an attorney in fact empowered by a power of attorney registered in the Registro Público; ID/passport copies; the operating licence (licencia de operación) and public registry certificate or notice of operation; colour copies of the legal manufacturer's technical literature (catalogues, data sheets, manuals, product data, instructions for use); the instructions for use and/or insert for each device; a notarised and certified copy of the legal manufacturer's letter of commitment authorising its distributor; a notarised sworn declaration of the applicant; a notarised and certified copy of the ISO 13485 certificate for every manufacturing site; a notarised and certified copy of the current Certificado de Libre Venta from the competent authority of the country of origin and/or provenance (with an explanatory note from that authority where no CLV is issued); a legible colour copy of the device labelling; the list of accessories and consumables; storage/transport instructions; the final disposal method; proof of payment; and, where applicable, an analysis certification from the Instituto Especializado de Análisis. Class A devices and IVDs follow separate chapters.

Pending draft reglamento (NOT in force): the local filing deltas for a device registration are — technical literature in a language other than Spanish must be filed translated with the seal of a public translator authorised in the Republic of Panama ('traductor público autorizado en la República de Panamá'); the manufacturer's letter of commitment and the ISO 13485 certificate must be filed as notarised and certified copies ('copia notariada y cotejada'), one ISO 13485 certificate per manufacturing site; the CLV must likewise be a notarised and certified copy; the applicant's sworn declaration must be notarised; and the application form must be signed by the legal representative or an attorney in fact whose power of attorney is registered in the Registro Público.

Every legal document of foreign origin must be consularised and legalised, or apostilled, and translated into Spanish by a public translator registered with the Paraguayan Supreme Court of Justice. Every technical document of foreign origin must likewise be translated into Spanish by a public translator registered with the Supreme Court.

An imported medical device application is built from: (a) evidence of compliance with GMP/BPF in production issued by the competent authority in origin, or an ISO 13485 / CE / UL / FDA / TUV / MDSAP or equivalent certificate from a certification body; (b) the manufacturer's power of representation or distribution authorisation letter registered in the Registro Público de Poderes; (c) the third party manufacturing contract where part or all of production is outsourced; (d) the free sale certificate or sanitary registration certificate or equivalent from the competent authority of the country of manufacture and/or commercialisation; (e) the finished product quality control certificate covering functionality, quality and safety tests, or a product conformity certificate issued by a Notified Body; (f) stability studies; (g) label and instructions for use translated into Spanish; and (h) the ARRN radiation licence where applicable.

Class I registration: declaration jurida application; free sale certificate (imports); manufacturer BPM or equivalent quality certificate (CE, ISO 13485, FDA or others); informe técnico per Art. 130; technical studies (design verification/validation summary, declaration of conformity, certificate of analysis if any); labeling draft; instructions for use manual in Spanish. On reinscripción, items 4 7 are deemed submitted via sworn declaration that the technical information is unchanged or changes are authorized.

Class II adds to the Class I set an ISO risk management report ('Informe de gestión de riesgo, según norma ISO específica vigente'); on reinscripción items 4 8 are deemed submitted via sworn declaration of unchanged or authorized changes.

Classes III and IV further require, for sterile devices, copies of sterilization process validation reports, an ISO specific risk management report, and item 9 'Informe de evaluación clínica' (clinical evaluation report), plus Spanish manual; on reinscripción items 4 10 are deemed submitted via sworn declaration.

Documents issued abroad must be no older than two years from issuance (unless the document itself states a different validity) and must be accompanied by a simple (non certified) translation into Spanish.

AO 2018 0002 prescribes Annex A (legal requirements for notification Class A and registration B/C/D) and Annex B (technical requirements for Class A notification); Annexes C, D and E contain the technical requirements for initial registration of Class B, C and D in accordance with the CSDT Template; Annex F covers renewal; Annex G covers medical device listing.

Class A CMDN checklist (2025): notarized Agreement/Letter of Authorization; for imported devices a valid government issued quality certificate or ISO 13485 certificate (product in scope, notarized declaration); country of origin authorization evidence; clear pictures of the actual product; device description (intended use, instruction for use, raw materials list, technical specification); metrology Certificate of Conformity for measuring devices; Declaration of Conformity with product standards; label pictures for all codes; declaration of shelf life.

All documents must be submitted in English; documents in any other foreign language must be accompanied by a notarized English translation for legal documents and an English translation for technical documents; uploads must be searchable PDF of at least 150 dots per inch, named after the requirement, with a table of contents and page numbers.

Information and documents requested by URPL from manufacturers or authorised representatives (MDR Art. 10(14)/11(3), IVDR Art. 10(13)/11(3)) must be submitted in Polish or English; URPL may require a Polish translation of specified documents; if the manufacturer does not comply, URPL may issue a decision prohibiting or restricting availability or withdrawing the device.

A foreign manufacturer's SRN application must attach: a registry extract not older than 3 months, legalised by a Polish consul or apostilled; where the extract does not show the representing persons, a notarised representation statement (also not older than 3 months, legalised/apostilled); and the MDR Art. 11(1) mandate; documents in a foreign language require a sworn translator's certified Polish translation.

Documents, elements and information submitted to INFARMED (and to the authority responsible for notified bodies) under DL 29/2024 must be in Portuguese or accompanied by an official translation into Portuguese, unless expressly waived by INFARMED.

All documents submitted with the IMD registration application must be valid for a minimum of 6 months from the date of submission.

IMD registration requires a Free Sale Certificate (FSC) for the device from the country of origin.

IMD registration requires a laboratory analysis report and a safety data sheet as checklist documents.

IMD registration requires the registration certificate of the manufacturer(s) as a checklist document.

IMD registration requires product information (Finished Product Specifications) including description, design, sizes, models, accessories, uses, side effects, warnings, precautions, brochures, and manuals; multiple models/sizes are listed in a separate excel sheet attached to the form.

Where applicable, the IMD application must include description and technical details of accessories/kits needed to implant or manage the IMD, and any specialized training/certification needed by clinical professionals plus certification for the local representative providing clinical and technical assistance.

The manufacturer's EU declaration of conformity is translated into Romanian or English (per MDR art. 19(1)); IVD equivalent in Art. 3(9) OUG 137/2022.

At ANMDMR's request, the manufacturer or authorised representative must transmit all information and documentation demonstrating conformity: drafted in Romanian for manufacturers established in Romania, or in English and translated into Romanian for manufacturers outside Romania.

Registration dossier documents must be submitted as colour PDF files with a text layer at resolution of at least 300 dpi; individual files must not exceed 100 MB.

Documents drawn up in a foreign language must be submitted with a translation into Russian certified by the applicant.

A registration application (as opposed to a notification) comprises a cover letter to the Director General, the registration application form, a technical documentation / technical file in Table of Contents (ToC) format, a declaration of conformity signed and dated by the manufacturer, copies of referenced literature and supporting documents, two commercial samples with a certificate of conformity where applicable, and a Rwanda FDA QMS audit certificate or proof of QMS audit application for Class C and Class D devices. The technical documentation must demonstrate conformity with the Essential Principles through a manufacturer controlled EP checklist that identifies each applicable principle, the chosen method of demonstrating conformity and the reference of the controlling document. Submissions may be in any of the official languages. The declaration of conformity must state the manufacturer's information, the authorised representative where applicable, device information, risk classification, and a statement of conformity including applicable regulations or standards.

Technical documents must be submitted to SFDA in English unless SFDA has previously agreed to accept another language; if another language is used, an English translation of the relevant parts must be provided. Documents may alternatively be kept available for inspection on the same language terms.

The MDMA dossier includes administrative details (manufacturer, AR license and national registry number, authorized contact, undertaking), and technical requirements: conformity with the essential principles, technical documentation (device description, design and manufacturing information, risk management file, verification and validation including clinical trials, PMS plan, PSUR/PMS reports), labelling copy, environmental/usage information for the Kingdom, classification, QMS proof per Art. 22.1, and a Declaration of Conformity.

The composition of the application dossier for a device marketing authorisation, for a variation, for a renewal, for an import authorisation and for a distribution agreement, and the modalities of the class A declaration, are each fixed by a decision of the Director General of the ARP rather than by the decree or the arrêté. Those decisions are not published on the ARP's decisions page, so the exact national dossier contents — and whether any origin country document is required at national level — cannot be confirmed from a published official source. The regional UEMOA harmonised dossier is the only published statement of what the device dossier contains.

For comparison with the manufacturer's original version the applicant also submits: outer/inner packaging proposal in English; for patient self use devices the packaging proposal also in Serbian; IFU in English for foreign origin devices and an IFU in Serbian for both foreign and domestic devices signed by a physician (for IVDs also by a biochemistry professional). Documentation is submitted to ALIMS in electronic form in Serbian (English accepted except for the IFU and patient self use packaging proposals, which must be Serbian); paper submission is exceptional.

Registration dossier (bylaw Art. 10): (1) Declaration of Conformity (original in electronic or paper form, or certified copy); (2) EC Certificate (notified/appointed body certificate), except for Class I and other IVD devices (IVD class A); (3) for Class I / other IVD / IVD class A manufacturers from non EU, non MRA, non PECA countries: an ISO 13485 / SRPS EN ISO 13485 quality management certificate from an accredited certification body, or proof the device is on the market in an EU/MRA state; (4) written authorisation of the foreign manufacturer for the AR with certified translation. Certificates may be submitted as scanned copies with a link to the issuing body for authenticity verification.

Registration requires that the device's overall intended benefits to the end user outweigh the overall risks, and that based on conformity with the safety and performance requirements published on the Authority's website the device is suitable for its intended purpose with risks minimised (reg 25).

Registration submissions are prepared in the ASEAN Common Submission Dossier Template format per GN 17/GN 18 (R4, Oct 2025) and submitted electronically; HSA also publishes an E Submission Guide for ASEAN CSDT and IMDRF ToC based submissions (R4, Oct 2025).

The ŠÚKL notification/registration package comprises: (1) cover letter; (2) original power of attorney (Slovak, officially translated, or multilingual with Slovak text); (3) registration/notification data form in 2 copies; (4) annex per device in 2 copies; (5) EU Declaration of Conformity (English, multilingual with English, or translated into Slovak); (6) notified body certificates (plus 2023/607 transition declarations — manufacturer solemn declarations and NB confirmation letter); (7) instructions for use in Slovak (printed, double sided, or on electronic carrier if extensive); (8) outer packaging label artwork in Slovak (photo or physical packaging; missing Slovak data may be added as a sticker with the manufacturer's written consent); (9) fee settlement proposal (Návrh na vyúčtovanie) in 2 signed copies.

Applications filed with JAZMP must be in Slovenian; exceptions (Slovenian or English allowed): exceptional approval applications under Art. 8, clinical investigation applications (Art. 70 MDR), performance study applications (Art. 66 IVDR) and notified body nomination applications.

An establishment licence application is made on a form approved by the Council and must include documentary proof of the particulars of the owner of the business, the particulars of the authorised representative, certification to a Quality Management System as determined by the Council, specification of the devices (or groups/families) to be manufactured/imported/exported/distributed, and the application fee.

A device/IVD registration application (when called up) must be in English, on the appropriate form, accompanied by the proposed label, the instructions for use, a copy of the manufacturer or distributor licence with a QMS conformity assessment certificate, a certified copy of the conformity assessment certificate for the device issued by a Conformity Assessment Body, a declaration of conformity, and the application fee; where the device is registered abroad, a certified copy of the foreign certificate of registration or premarket approval must accompany the application. Applications are per individual device, group/family or modification.

Approval applications include, where applicable, the technical documentation review result notification (기술문서 등의 심사결과통지서) among the required attachments, linking the separate technical document review to the product application.

The technical documentation required to demonstrate conformity with the general safety and performance requirements must be drawn up in accordance with Annex II to Regulation (EU) 2017/745 (device description and general information, information supplied by the manufacturer, information on design and manufacture, general safety and performance requirements, benefit risk analysis and risk management, product verification and validation) together with the post market surveillance technical documentation of Annex III, and kept available to the competent authorities.

Mandatory common documents: Letter of Authorization from the legal manufacturer (tabulated if multiple local agents, with product range and site), declaration letters (dossier type, sample submission on request), agency transfer letter if applicable, a valid original Free Sale Certificate (or QR/web link verification at fee payment), NMRA GMP report for local manufacturers if applicable, FMSA approval or product registration certificate, ISO QMS certificate, and foreign country registration evidence.

PRD technical documents include application Forms A and B and Form C (SIL), device details from the manufacturer, declaration of conformity / EC full quality assurance certificate, STED per GHTF, Essential Requirement checklist per GHTF, risk analysis report (e.g. ISO 14971), COA or finished product test report, stability data, sterility/EO/package integrity reports for sterile devices, biological evaluation report, clinical evaluation test report if applicable, electrical safety and EMC data for active devices, metrology certification for measuring devices, Atomic Energy Authority approval for radiation emitting devices, software verification and validation report, BSE report for animal derived materials, labels, catalogue, IFU and PIL, and IVD performance evaluation reports.

For acceptance of new dossiers and re registration dossiers, importers must submit: comprehensive table of contents (index), application form signed by authorized person (Schedule 1 Form A/Form B), LOA from legal manufacturer, FMSA approval copy if applicable, NMRA GMP report for local products, copy of sample licence (new) / previous registration (RR), original free sale certificate, hygienic certificate if applicable, ISO certificate, EC certificate, EC design examination certificate if applicable, COA, stability report, sterility report, EO residual report, electrical safety data, IVD performance evaluation report, biological evaluation report, third party test report, BSE report, Atomic Energy Authority approval for radiation emitting devices, other country registration evidence list, accessories list, IFU for IVD kits, and labels/catalogue.

Information and documentation submitted to Läkemedelsverket (e.g. technical documentation provided on request) may be in Swedish or English; the EU declaration of conformity may be in Swedish or English; but the clinical investigation summary submitted with the application (MDR Annex XV Chapter II point 3.1.5) must be in Swedish.

The CH REP must keep a copy of the technical documentation available; alternatively, the manufacturer and CH REP may agree contractually that the manufacturer delivers the documentation directly to Swissmedic on request, in which case the CH REP must ensure delivery to Swissmedic within seven days.

Technical documentation must be compiled in accordance with Annexes II and III EU MDR and kept available; records must be retained for at least 10 years after the last device covered by the declaration of conformity was placed on the market, and at least 15 years for implantable devices.

Class I registration applications must include the documents and data of Annex 1 (documents for Class I device registration for manufacture or import); the central authority may decline to register the specification/model and label/IFU/packaging items (Art. 5 para. 2).

Class II and III registration applications must include the documents and data of Annexes 2 and 3, which include (per the regulation's definitions and extension article) the country of origin free sale certificate, foreign manufacturer letter of authorization, QMS conformity evidence, and for Class II a product comparison and pre clinical test data conformity declaration (產品比較暨臨床前測試資料符合性聲明書, Annex 3).

Licence extension applications require the application form, original licence, country of origin free sale certificate, foreign manufacturer letter of authorization, QMS evidence and the fee, submitted within the statutory window before expiry.

Application documents must be in Traditional Chinese or English; documents in other languages must be accompanied by a Traditional Chinese or English translation.

All applications and supporting documents must be in Kiswahili or English.

Applicants must have the device's class, intended purpose, GMDN code and term, conformity assessment certification and declaration of conformity before submitting; if the device is coded under another system instead of GMDN, that system must be specified.

New and re registration applications for single use devices must be accompanied by two commercial packs of samples (additional samples may be requested during evaluation); small reusable devices and lay use devices likewise require two samples; applications without samples do not proceed to assessment.

For large medical devices, devices that are part of hospital infrastructure, and cardiac implants, submission of label artwork and scaled pictures of the device from different angles giving a 360 degree view suffices in lieu of physical samples.

The class 4 licence application must include, among the documents listed in ข้อ ๒, a quality system certificate (หนังสือรับรองระบบคุณภาพ).

Technical documentation is submitted in the Common Submission Dossier Template (CSDT) format.

For a device placed in the 'analyse' track rather than the 'avis technique' track, the dossier must contain, in addition to every document required for an avis technique: a dated and signed lot analysis report including the tests performed, the acceptability intervals of the specifications and the normative reference associated with each test; and a detailed description of the analysis methods. Where the finished product's specifications at expiry differ from those at release, both must be provided with their acceptability intervals.

The device technical dossier for the 'avis technique' track is built from the following documents: (a) the fiche de liaison; (b) the Autorisation Provisoire d'Enlèvement (APE); (c) the detailed purchase invoice describing all the products concerned; (d) the free sale certificate from the country of origin; (e) the manufacturer's declaration of conformity; (f.1/f.2) the EU conformity certificate or its MDR transition alternative; (g) or the US conformity document; (h) or the Canadian licence; (i) the physico chemical and microbiological analysis report for non solid forms; (j) the sterility attestation for sterile devices; (k) the biocompatibility attestations; (l) the animal origin attestations; (m) the labelling mock up. The APE (Autorisation Provisoire d'Enlèvement) is therefore a required filing document alongside the conformity evidence.

The manufacturer's declaration of conformity in the Tunisian device dossier must state at least: the manufacturer's name and address; the product's trade name, product code, lot number or any other unique reference allowing identification and traceability of the device covered by the declaration of conformity; the Basic UDI DI (IUD ID); a declaration of which legislation the device complies with (the example given is Regulation (EU) 2017/745 or other); the place and date of issue plus the signatory's name and full details; the reference to the ISO and EN standards to which the device is declared conform; the device's risk class (I, Is, Im, IIa, IIb, III); and, where applicable, the notified body's name and identification number, a description of the conformity assessment procedure followed and the reference of the certificate(s) issued.

Beyond the regime level conformity certificate, the Tunisian device dossier requires product type specific evidence. For non solid devices (solution, gel, cream, paste): the physico chemical and microbiological analysis report for the finished product for each lot, stating the acceptance interval of the specifications for each test, dated and signed by a responsible person, plus the complete qualitative and quantitative composition — and where CMR substances are present the manufacturer must comply with Annex I, Chapter II, point 10.4 of Regulation (EU) 2017/745. For sterile devices: an attestation of sterility stating the lot numbers and expiry dates of each article, the normative reference of the sterilisation process, and the date and visa of the responsible person; a sterility test result on an analysis report may be accepted. For biocompatibility: ISO 10993 1 attestation for all devices, ISO 10993 7 for ethylene oxide sterilised products and ISO 10993 11 for pyrogen free products, each established by the manufacturer. For animal origin devices (collagen, bone): ISO 22442 and/or Regulation (EU) 722/2012 attestation established by the manufacturer.

For importer company registration of declarations of conformity / EU declarations in UTS, the original document must be apostilled by the competent authority of the manufacturer's country (or legalized via Turkish embassy/consulate); e Apostille is accepted with verification; documents in foreign languages require a sworn translator's Turkish translation; certificates must be e signed, otherwise a Turkish notary certified copy or verification via the notified body's official site or EUDAMED is required.

A separate and complete dossier in electronic form must be submitted for each surgical instrument, appliance, group or family. DAR/GDL/028 s. 4.3.3.1 sets out two content sets. For class A the dossier is the filled application form (Appendix I), a letter of authorization, the IFU/patient information leaflet and promotion material including brochures and catalogues, labelling information, information on sterilization methods and validation standards where applicable, and proof of a quality management system such as an ISO 13485 certificate. For classes B, C and D the dossier is the filled application form, a letter of authorization, information on appliance details, a summary of technical documentation, labelling information, evidence of conformity to the Essential Principles / Essential requirements checklist (Appendix II), and proof of a quality management system such as an ISO 13485 certificate. The statutory application particulars are listed in reg. 27(4) of S.I. 2014 No. 29 (items (a) to (l)), and DAR/GDL/028 s. 4.3.2 lists the substantive technical requirements for high risk instruments, including manufacturing process and flowchart, contract manufacturer relationship letters and technical agreements, ICH zone IV stability studies, laboratory QC analysis files, performance and safety clinical studies where applicable, distribution status and English leaflet and labelling artwork.

The manufacturer must keep conformity assessment documentation for at least 5 years, and for implantable medical devices at least 15 years (Annex 3, point 16, TR 753).

The notification to the Register must be supported by documents confirming the stated data; an authorized representative additionally submits the manufacturer's written mandate (power of attorney, agreement or contract); a certified power of attorney including declaration rights and the prescribed notification form (Annex 2 to MoH Order 122) are required.

Safety and efficacy data must be submitted for devices classified as Class III or IV.

Device registration requires quality conformity / marketing authorization evidence matched to the device class: EC certificate, FDA 510(k) clearance, or PMA approval.

Device registration requires a valid free sale or registration certificate from the competent authority of the country of origin, certified by the UAE Embassy.

To affix the UKCA marking, the manufacturer (or its UK responsible person) must fulfil the applicable obligations imposed by Annex VII to the Medical Devices Regulations 2002 including technical documentation and the declaration of conformity procedure with Annexes II to VI applying in addition for higher class routes; the EU declaration of conformity for a legacy CE route device must have been drawn up before 26 May 2021 and translated into English.

A 510(k) must contain the items of 21 CFR 807.87(a) (m), including device description, proposed labels and labeling, substantial equivalence discussion, a 510(k) summary or statement (807.87(h)), truthfulness and financial certifications, and clinical data meeting 807.87(j) including for studies conducted outside the United States the investigator and study site information required by 21 CFR 812.28 (807.87(j)(2)).

A PMA (21 CFR 814.20) must contain the items (a) (h): full report of investigations, nonclinical laboratory studies, description of methods, facilities and controls, referenced information, samples or their location, proposed labeling, and environmental impact; applications from foreign applicants require the signature of a US resident representative; clinical investigations must comply with 21 CFR parts 50, 56, and 812, with 21 CFR 812.28 information for studies conducted outside the US and financial certification/disclosure under 21 CFR part 54; applicants must also submit status reports every 3 months while the PMA is pending.

The technical report must contain: a) detailed description of the product including operating rationale and action, composition and accessories; b) manufacturer stated intended use/indication; c) precautions, restrictions, warnings and special care including storage and transport; d) presentation forms; e) flow diagram of manufacturing stages with a summary of each; f) description of safety and efficacy (essential requirements) if safety and efficacy are not demonstrated, MSP may require a clinical investigation at the charge of the importer or manufacturer.

The registration file (carpeta) comprises: habilitación/registry constancia; technical specifications of the product; commercial documentation attached to the product (brochures, instructions, user manuals, warranties); certificate of free sale of the country of origin; sworn declaration of new/used/recycled status; and a solicitud form presented per family with numbered folios, a table of contents (formulario/rótulo/CLV/información técnica folios), copies of quality certificates the company holds (if applicable) and the technical report. Free sale certificates must have the products to be registered marked on them.

For medical equipment, a sworn declaration states whether the equipment is new, used or recycled with year of manufacture; used equipment requires a local recycling protocol, a copy of the free sale certificate of the country of origin, user and service manuals, and a sworn declaration by the representative detailing recycling, pre installation, installation and after sales capability; recycled equipment requires a management system with process traceability. Providers with expired registrations may renew once if the equipment remains operational.

The applicant submits: the trilingual application form; registration documents in electronic form confirmed by the applicant's electronic digital signature per Annex 3 (device information incl. GMDN and UDI where available, manufacturer and site information, standards list, risk management report, sterilization validation for sterile products, verification/validation test reports, biological evaluation, stability with state language translation, adverse event and withdrawal report plus post market data collection/analysis plan, clinical safety/performance report for classes IIa III, labeling and IFU); device samples; ISO 13485 certificate copy; declaration of conformity; certificate of registration in the country of manufacture or free sale/export certificate with state language translation; photos/catalogues; production inspection report; IP documents.

Submitted foreign certificates and registration certificates are verified for authenticity against the issuing authority's official registers (websites); where verification through open sources is impossible, all official documents must bear an apostille or consular certification.

Ministry of Health Order No. 10 of 20.05.2026 (registered by the Ministry of Justice No. 3888 on 07.07.2026) approves the Guidance (Йўриқнома) establishing the requirements for medical device state registration documents.

The contents of the Class A/B declaration of applied standard dossier are specified in a dedicated article (Art. 24) of Decree 98.

Circular 44/2025 prescribes standard templates for the power of attorney (Phụ lục V), warranty capability certificate (Phụ lục VI), device technical documentation (Phụ lục VII) and export/import/inventory/use reporting (Phụ lục VIII); POAs and warranty certificates issued under TT 19/2021 (as amended by TT 10/2023) remain accepted.

statement: The non IVD dossier follows a six chapter table of contents supplied in the guideline: Chapter 1 Administrative (cover letter, table of contents, application form, listing of devices, quality management system and other regulatory certificates, free sale certificate or certificate of marketing authorisation, expedited review documentation, statements and declarations of conformity); Chapter 2 Submission Context (general summary, device description, indications for use and contraindications, global market history with incident reports and recalls and sales/incident/recall rates, and evaluation or inspection reports); Chapter 3 Non clinical Evidence (risk management, Essential Principles checklist, standards, and physical, chemical, electrical, radiation and software studies); Chapter 4 Clinical Evidence; Chapter 5 Labelling; and Chapters 6A and 6B on quality management system procedures and device specific QMS. The Annex II checklist requires the administrative information, the certificates listed above, the technical information 'as per Non IVD MA ToC (Chapters 1 6) for Class B to D and as per Annex II for Class A Devices', and any other relevant documents.

statement: The device application is a short administrative and technical form rather than a CTD dossier. Form M.C.Con.1 requires the applicant's particulars and registered office, the name under which business is conducted, the manufacturer's name and physical address, whether alternative sources of manufacture exist, the importer's and distributor's names and addresses, the trade mark and distinguishing marks, how the condom is packed and how it will be offered for sale to importers, wholesalers, retailers and the public, the type of sealing for individual packs, the specifications of the condoms including shelf life, a summary of the methods used to ensure compliance with specifications, an explanation of all packaging codes, and the number of samples submitted. The form must be submitted in duplicate with the application fee and the required samples, and an undertaking to pay testing costs with a deposit. Form M.C.G.1 for gloves is structured the same way.