Dossier de soumission règlementaire au format IMDRF

Cet outil reprend le plan de soumission d’un dossier règlementaire au format IMDRF (voir l’article).

Il est utilisé pour organiser la documentation technique du dispositif, en tenant compte des exigences règlementaires internationales (USFDA, Santé Canada, TGA, ANVISA, CFDA, Europe et Japon).

La majorité des dossiers sont communs (notés IMDRF), d’autres sont utilisés en fonction des régions.

Sources :

Modèle de dossier et explications de l’IMDRF
Matrice de correspondance Santé Canada
Exigences du règlement (UE) 207/745 relatives à la documentation technique générale et relative à la surveillance

Les dossiers ajoutés, en plus du modèle IMDRF, sont notés par un astérisque : *
Les modèles qualitiso utiles sont référencés.

Utilisation :

Le document est paramétrable
Vous pouvez trier les dossiers par zone règlementaire
Le sommaire s’adapte à votre sélection

1. RENSEIGNEMENTS ADMINISTRATIFS RÉGIONAUX

1.01. Lettre d’accompagnement

IMDRF : a) The cover letter should state applicant or sponsor name and/or their authorized representative, the type of submission, the common name of the device (if applicable), device trade name or proprietary name (both of the base device and a new name if one is given to the new version/model of the device) and include the purpose of the application, including any changes being made to existing approvals.
b) If applicable and accepted by the regulator, it should include information pertaining to any Master Files referenced by the submission.
c) If applicable, acknowledgement that a device sample has been submitted or offered alternatives to allow the regulator to view or access the device (when the regulator requests a sample).
d) If the submission is requesting approval of a change that is the result of CAPA due to a recall, this should be stated.
e) If the submission is in response to a request for information from the regulator this should be stated and the date of that letter should be included as well as any reference number(s).
f) If the submission is unsolicited information (where accepted), this should be stated and any related reference number(s) provided.

NOTE: The cover letter should not contain any detailed scientific information.

CFDA : Attached documents should be signed or sealed by applicants and/or authorized representatives.

USFDA : a) mailing address,
b) official correspondent(s),
c) phone/fax number(s),
d) email address(s
e) cover letter shall be signed by applicant and an authorized rep (if the applicant does not reside or have a place of business in US) – 21 CFR 814.20(a) (PMA Only)
f) Device class and panel or classification regulation or statement that the device has not been classified with rationale for that conclusion (510(k) only)

TGA : The covering letter of application needs to be prepared on company letterhead and to also include;
a) Submission ID that is generated electronically when completing the application form in eBusiness
b) Contact details of the person authorised to liaise with TGA during the evaluation process
c) Signed by the authorised person for the company

1.02. Table des matières de la présentation

IMDRF : a) Includes at least level 1 & 2 headings for the entire submission b) Specifies the page number for each item referred to in the table.NOTE: Refer to the Pagination Section of this document for information about submission pagination.

1.03. Liste de termes et d’acronymes

📚 : Dictionnaire
§: Rq : les termes et acronymes sont indiqués dans les procédures

IMDRF : Terms or acronyms used in the submission that require definition, should be defined here.

HC : Lorsque de nouvelles conditions sont ajoutées.

1.04. Formulaire de demande / Renseignements administratifs

📚 : PRO.RDM
§: Inspection par un organisme notifié

ANVISA : ANVISA´s “Manufacturer or Importer Form” (form available at www.anvisa.gov.br), containing general information related to the application.

CFDA : Application form shall be filled out and submitted on line

UE : Notified Bodies (NBs) will each have their own application form and company information form, including details on the submission type (new, renew, changes), administrative data of the manufacturer, overview of subcontractors and their QMS certification documentation, underlying CE certificates in case of Own Brand labelling, general information of the product, including sterilisation method where applicable, nature of selected starting materials (e.g. drugs, animal tissue), applicable directive and classification. Consult relevant NB.N.B. Under EU legislation, the Own Brand Labeller is to be considered as the legal manufacturer and bears the regulatory responsibility of a manufacturer including the need to dispose of the entire technical documentation (see the EU Guideline on OBL: http://ec.europa.eu/health/medical-

HC : Si cela est pertinent dans le cadre de la demande.

1.05. Liste des dispositifs

📚 : DOC.DGR
§: Identification du dispositif

IMDRF : A table listing each variant/model/configuration/component/accessory that is the subject of the submission and the following information for each variant/model:a) the identifier (e.g. bar code, catalogue, model or part number, UDI)b) a statement of its name/description that provides (e.g. Trade name, size, material)NOTE: i. A model/variant/configuration/component/accessory of a device has common specifications, performance and composition, within limits set by the applicant. ii. Typically each item listed should be available for sale. For example, if everything is sold as part of a kit, then this list would only include the kit. You do not need to list all components that may be sold within a kit/set, unless the component is available for sale independently of the kit.iii. This is classified as RF in recognition that identification numbers may vary from jurisdiction to jurisdiction.

ANVISA : The grouping (family, set and systems) of medical devices shall be in compliance with ANVISA´s requirements which specify the conditions to establish grouping of medical devices.

TGA : For all classes of devices the applicant needs to include: a) The Global Medical Device Nomenclature (GMDN) Code and Termb) The classification and the applicable classification rule For class III and AIMDs this table should also identify the following:c) Unique Product Identifiers (see the Therapeutic Goods (Medical Devices) Regulations 2002)d) Variants (as defined in the Therapeutic Goods (Medical Devices) Regulations 2002)

UE : The listing should include the relevant Global Medical Device Nomenclature (GMDN) Code and Term

RU : Any model/variant/configuration of device(s) listed should be limited (covered) by a single Global Medical Device Nomenclature (GMDN) Code and Term. The components within a kit/set can have their own GMDN Codes/Terms.

DT UE : a) Le nom ou la dénomination commerciale du produit

1.06. SMQ, système de première qualité ou autres certificats réglementaires

📚 : SMQ
§: Rq : templates relatifs au SMQ

ANVISA : Good Manufacturing Practice Certificate (GMPC) issued by ANVISA, covering the scope of products.NOTES:a) Device registration or amendment request to change/include manufacturer of Class III or IV devices requires a valid GMP Certificate issued by ANVISA. However, submission review may be initiated prior to GMP certification. In these cases, the document proving that the application for the GMP Certification has been submitted to ANVISA should be presented, identifying the manufacturer name, the address of the site to be certified and the identification number of the GMP Cert application to ANVISA. The registration or amendment will only be approved after the GMP certificate has been issued. b) Device registration renewal submissions of Class III or IV devices, also requires a valid GMP Certificate issued by ANVISA. The document proving that the GMP Certification was requested from ANVISA will be accepted if the GMP Certificate has not yet been issued. However, if the final result of the GMP certification process leads to a refusal, the device registration will be canceled.

CFDA : a) Domestic applicant shall provide: i. Copies of business license and organization code certificate. ii. When applying for registration of domestic medical devices according to Special Procedure of Approval and Evaluation for Innovative Medical Devices, applicant shall provide a notice of application for reviewing “Special procedure of approval and evaluation for innovative medical devices”, and if the sample products are produced by entrusted manufacturers, manufacturing license of the entrusted manufacturer and consignment agreement shall be provided. The scope of manufacturing license shall cover the category of the submitted products.

TGA : Copies of any current TGA or other regulatory authority certification referenced within the submission or required for the submission type. The reference certificates requirements will vary based on the submission type, refer to TGA guidance for these requirements.

UE : EN ISO 13485 certificate in case it is issued by another Notified Body or registrar. CE full quality system certificates (QMS and annex II.3 MDD) covering the scope of products when issued by another Notified Body.

HC : This subsection includes a copy of the quality management system certificate certifying that the quality management system under which the device is designed and manufactured satisfies CAN/CSA ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes. Health Canada will only accept quality system certificates that have been issued by special third party auditing organizations recognized by the Minister in accordance with Section 32.1 of the Medical Devices Regulations.

1.07. Certificat de vente libre / Certificat de mise en marché

📚 : PRO.RDM
§: Certificat de libre vente

ANVISA : Document/certificate issued by the Regulatory Authority where the medical device is marketable, attesting that the device is marketable, without any restriction at their jurisdiction

CFDA : a) Imported Medical Device applicant shall provide: i. Supporting documents of marketing authorization or certificate of the product issued by authority of the country (or region) where the applicant’s headquarter or manufacturing site is located, and the authorization/qualification documents of the enterprise ii. If the product is not managed as a medical device by authority of the country (or region) where the Imported medical device applicant is located, applicant shall provide relevant supporting documents, quantification certificate of manufacturer issued by authority of the country (or region) where the registration office or manufacturing site is located(for registration).b) Applications for extension renewal and change registration shall include:i. Copies of the original registration certificate of medical device and its appendices, and copies ANVISADocument/certificate issued by the Regulatory Authority where the medical device is marketable, attesting that the device is marketable, without any restriction at their jurisdiction.CFDA a) Imported Medical Device applicant shall provide: i. Supporting documents of marketing authorization or certificate of the product issued by authority of the country (or region) where the applicant’s headquarter or manufacturing site is located, and the authorization/qualification documents of the enterprise ii. If the product is not managed as a medical device by authority of the country (or region) where the Imported medical device applicant is located, applicant shall provide relevant supporting documents, quantification certificate of manufacturer issued by authority of the country (or region) where the registration office or manufacturing site is located(for registration).b) Applications for extension renewal and change registration shall include:i. Copies of the original registration certificate of medical device and its appendices, and copies of all documents on the change of registration of medical device in China (for).ii. For Imported Medical Device, the relevant documents if the new market clearance issued by the medical device authority of the country (or region) where the overseas applicant’s registration office or manufacturing site is located is required for change items; or description if the change items need not to be approved by the medical device authority of the country (or region) where the overseas applicant’s registration office or manufacturing site is located.

1.08. Frais

ANVISA : a) Receipt of the User Fee payment. Information about User Fee available at:
http://portal.anvisa.gov.br/taxas1

USFDA : FDA User Fee Form

UE : Signed quote and agreement for dossier review/audits

1.09. Correspondance préalable à la présentation et interactions antérieures avec les organismes de réglementation

📚 : PRO.RDM
§: Inspection par un organisme notifié

IMDRF : a) During the product lifecycle, pre-submission correspondence, including teleconferences or meetings, may be held between the regulator and the applicant. Further, the specific subject device may have been subject to previous regulatory submissions to the regulator. The contents should be limited to the subject device as similar devices are addressed in other areas of the submission. If applicable, the following elements should be provided:i. List prior submission or pre-submissions where regulator feedback was providedii. Prior submissions should include identification of submission #iii. For any pre-submission activities that have not previously been assigned any tracking/reference number, include the information package that is submitted prior to pre-submission meetings, the meeting agenda, any presentation slides, final meeting minutes, responses to any action items arising from the meetings, and any email correspondence related to specific aspects of the application.iv. Issues identified by the regulator in prior submissions (i.e., clinical study applications, withdrawn/deleted/denied marketing submission) for the subject devicev. Issues identified and advice provided by the regulator in pre-submission interactions between the regulator and the applicant/sponsor.vi. Explain how and where the prior advice was addressed within the submissionORb) Affirmatively state there has been no prior submissions and/or pre-submission interactions for the specific device that is the subject of the current submission.NOTEThe scope of this section is limited to the particular regulator to which the submission is being submitted (i.e. Health Canada does not need pre-submission information relating to interactions with ANVISA).

CFDA : For example, innovative medical device communication record.

UE : a) A statement is required that the product to be reviewed is not under application with another Notified Body, and has not previously been refused or cancelled by another notified body.b) For “borderline products”, where applicable, any rationale, supportive documentation and key documentation on communication with an EU Competent Authority and/or COM services, relating to the qualification/classification decision on such product.c) In case of transfer from another Notified Body, that status, including any open Non-conformity, and the associated dossier review reports, the latest audit report and for QMS transfer all audit reports from the existing certification cycle, will need to be submitted along with a letter of access from the new notified body to contact the old notified body to confirm any open issue. This will allow a specific date of transfer of application and CE marking.

HC : Lorsque cela est pertinent

1.10. Liste de contrôle pour acceptation

USFDA : PMA : Optionally, you may complete the checklist and provide section and pages numbers indicating where every item on the check is addressed in the submission. See Appendix A of the Acceptance and Filing Reviews for Premarket Approval Applications (PMAs): Guidance for Industry and Food and Drug Administration Staff Guidance510k : Optionally, you may complete the checklist by answering the preliminary questions and providing the pages numbers indicating the locations of each item on the check is addressed in the submissionSee the Acceptance Checklist for Traditional 510(k)s in Refuse to Accept Policy for 510(k)s : Guidance for Industry and Food and Drug Administration Staff

TGA : Includes the Supporting data checklists

1.11. Énoncés / certifications / déclarations de conformité

1.11.01. Performance*

📚 : DOC.DGR,PLN.EVL.CLI
§: Principe de fonctionnement du dispositifPerformances cliniques

USFDA : Note to RPS Team: USFDA wants this information displayed here in the admin section but will request it in Chapter 3 where standards information other IMDRF members request (List of Standards)

1.11.01. Norme volontaire*

📚 : PRO.GNR
§: Liste de normes et réglementations applicables

DT UE : c) les normes harmonisées,

1.12.02. Évaluation environnementale

USFDA : PMA : a) If claiming categorical exclusion, information to justify the exclusion

b) Provide the environmental assessment (only required for devices that present new environmental concerns

1.11.03. Certifications d’essais cliniques

USFDA : a) Certification of Compliance with Requirements of ClinicalTrials.gov (Form FDA 3674)b) Financial Certification or Disclosure Statement (Form FDA 3454 and Form FDA 3455)

1.11.04. Indications d’utilisations avec catégorisation Rx ou OTC

USFDA : 510k : Use Form FDA 3881

1.11.05. Déclaration véridique et exacte

ANVISA : a) A declaration (per text below), dated and signed by the legal representative and technical manager of the company:“We declare that the information provided at this submission are truthful and accurate, and can be proven by documental evidence and that no material fact has been omitted. We also declare that:i. The device will be marketed observing all requirements established by the Brazilian Legislation;ii. The labelling (e.g. labels, instructions of use, promotional material) of the device complies with the Brazilian regulatory requirements, and will be maintained up to date during all the period that it will be available on the Brazilian market;iii. The device and accessories that accompany the device were designed and are manufactured attending the Essential Requirements of Safety and Efficacy and the Good Manufacturing Practices established by ANVISA;iv. All the reasonably foreseeable risks were identified and mitigated. The residual risk is acceptable in relation to the benefits obtained by the use of the devices;v. The devices delivered to the market will be continuously monitored in order to identify new risks that have not been already addressed, according to the Risk Management Plan established by the manufacturer.The company is aware that if the Brazilian regulatory requirements were not fulfilled, administrative sanctions established on federal law (Lei nº 6437/1977) shall be applied. The legal representative and technical manager of the company are aware that they are answerable to the court by any infraction indicated on art. 273 – Decreto Lei nº 2848/1940 (Criminal Code – Chapter III: Crime against Public Health).”

CFDA : The self-assurance declaration of the authenticity of submitted data (the ones of domestic products shall be issued by applicants and the ones of imported products shall be issued respectively by applications and agents.)

USFDA : 510k : a) Truthful and Accurate statement per 21 CFR 807.87(k). Text:I certify that, in my capacity as (the position held in company) of (company name), I believe to the best of my knowledge, that all data and information submitted in the premarket notification are truthful and accurate and that no material fact has been omitted.NOTE: Signed by a responsible person of the firm (not a consultant)

TGA : a) A statutory declaration is a written statement allowing a person to declare something to be true. The declaration is signed in the presence of a witness. Giving false or misleading information as part of a statutory declaration is a criminal offence under the Criminal Code.http://www.tga.gov.au/industry/manuf-statutory-declarations.htm#formsStatements of undertaking by the manufacturer as required by conformity assessment procedures set in the Therapeutic Goods (Medical Devices) Regulations 2002

HC : Attestation that statements in the application are true and that the information provided in this application and in any attached documentation is accurate and complete. Consult current Health Canada guidance for specific language.

1.11.06. Résumé et certification des dispositifs de classe III de l’USFDA

USFDA : 510k : Class III Certification and Summary per 21 CFR 807.94. Text:I certify that, in my capacity as (the position held in company) of (company name) that I have conducted a reasonable search of all information known or otherwise available about the types and causes of safety and/or effectiveness problems that have been reported for the (device name). I further certify that I am aware of the types of problems to which the (device name) is susceptible and that, to the best of my knowledge, the following summary of the types and causes of safety and/or effectiveness problems about the (device name) is complete and accurate.(Attach the summary of problem data, bibliography or other citations upon which the summary is based.)

1.11.07. Déclaration de conformité

📚 : PRO.RDM
§: Déclaration de conformité UE

IMDRF : As part of the conformity assessment procedures, the manufacturer of a medical device is required to make a Declaration of Conformity that declares that the device complies with:
a) the applicable provisions of the Essential Principles/Requirements
b) the classification rules
c) an appropriate conformity assessment procedure

CFDA : For registration:
i. A declaration that the product complies with the classification requirements of the Medical Device Classification Rules
b) For registration, change and extension renewal:
i. A declaration that the product complies with the relevant requirements of the Provisions for Medical Device Registration and the relevant regulations
ii. A declaration that the product complies with the current national standards, industrial standards, and provides an up-to-standard list

TGA : The wording of the Declaration of Conformity will depend on the conformity assessment procedure chosen by the manufacturer. Templates for each of the six possible types of Declarations of Conformity under Schedule 3 of the Therapeutic Goods (Medical Devices) Regulations 2002 are available at .

JP : Declaration and/or certificate that the relevant product is manufactured to conform to the essential principles and/or the quality management system.

NOTE: The applicant is advised to prepare the declaration of conformity according to ISO 17050-1 “Conformity Assessment – Supplier’s Declaration of Conformity – Part 1: General Requirement.”

DT UE : Le cas échéant, il convient de démontrer la conformité avec les dispositions de la directive 2004/10/CE du Parlement européen et du Conseil.

1.12. Lettre de référence pour le fichier maître

IMDRF : Letter from any Master File owner granting access to the information in the master file. The letter should specify the scope of access granted.

HC : Lorsqu’un fichier principal est cité en référence.

1.13. Lettre d’autorisation

ANVISA : When applicable, an authorization letter issued by the device manufacturer allowing the importer/authorized legal agent to market the device in the subject jurisdiction, according to requirement on RDC 36/2015.

CFDA : a) Evidence of power of attorney of the foreign applicant for designating agent in China.
b) Copies of the letter of commitment and business license or copy of organization registration certificate of agent.

1.14. Autres renseignements administratifs régionaux

IMDRF : Heading for other information that may be important to the submission but that does not fit in any of the other headings of this chapter.

HC : Lorsque l’organisme de réglementation demande des renseignements (par l’entremise de documents d’orientation ou d’autres communications), mais qu’ils ne correspondent à aucun autre titre de ce chapitre.

2. CONTEXTE

2.01. Table des matières du chapitre

IMDRF : a) Includes all headings and sub-headings for the chapter.
b) Specifies the page number for each item referred to in the table.

2.02. Résumé de la présentation

📚 : DOC.DGR
§: (voir ci-dessous)

IMDRF : a) Statement of the device type (e.g. hip implant, infusion pump, standalone software) and name (e.g. trade name, proprietary name), its general purpose, and a high-level summary of key supporting evidence (i.e. studies that are unique to the risks of this device type, for example burst testing of a ceramic femoral head; electrical safety evaluation (IEC 60601) testing for an infusion pump). b) Summary of submission, including i. The type of submission (e.g. new, amendment, change of existing application, renewal);ii. if amendment/supplement, the reason of the amendment/supplement;iii. if a change to existing approval, description of the change requested (e.g., changes in design, performance, indications, changes to manufacturing processes, manufacturing facilities, suppliers);iv. any high-level background information or unusual details that the manufacturer wishes to highlight in relation to the device, its history or relation to other approved devices or previous submissions (provides context to submission).

ANVISA : If renewal, amendment or change, identification of the registration/notification number issued by ANVISA for the device, family, system or set of devices and the number of the original application must be informed.

CFDA : a) If product registration, the applicant shall describe the management category, criteria for determining the classification codeb) If registration extension, the applicant shall provide the statement that no changes are made to the product.

USFDA : 510k : Executive Summary

TGA : If recertification or change to a conformity assessment certificate, identification of the affected TGA certificate numbers must be detailed.

UE : If renewal, amendment or change, identification of product (family) currently Marketed under CE mark and related certificate of MDD annex.

HC : If amendment or new submission based on currently licenced device(s), the Canadian Medical Device Licence Number(s) should be provided along with the description of the change requested.

2.03. Résumés et certifications préalables à la mise en marché

USFDA : PMA : a) Summary of the Content of the Whole PMA per 21 CFR 814.20(b)(3)
510k :
a) 510(k) Summary contains all elements per 21 CFR 807.92
OR
b) 510(k) Statement contains all elements per 21 CFR 807.93

2.04. Description du dispositif

HC : Si cela est pertinent dans le cadre de la demande.

2.04.01. Description exhaustive du dispositif et principe de fonctionnement

📚 : DOC.DGR
§: Principe de fonctionnement du dispositif

IMDRF : a) A general description of the device, including:
i. A statement of the device name
ii. What the device does?
iii. Who uses it and for what? (high level statement)
iv. Where to use it? (places/environment where the device is intended to be used)
v. How it works? Including theory surrounding feature/variants/operating modes that enable the device to be used for indications/intended use (principle of operation/mechanism of action).
vi. If applicable, labelled pictorial representation (diagrams, photos, drawings).
vii. If system, how the components relate?
viii. If applicable, identify if the device incorporates software/firmware and its role

b) Product specification, including:
i. Physical characteristics or relevance to the end user (dimensions, weight)
ii. Features and operating modes
iii. Input specifications (e.g. electrical power requirements, settings and associated allowable ranges/limits)
iv. Output and performance characteristics (e.g. range and type of energy delivered, resolution of images)
v. If applicable, an indication of the variants/models of the devices and a summary of the differences in specifications of the variants (comparison table and/or pictures/diagrams with supporting text).

c) Engineering diagrams/prints/schematics of the device.
d) List of accessories intended to be used in combination with the devices.
e) Indication of any other medical devices or general product intended to be used in combination with the medical device (e.g. infusion sets and infusion pumps, bipolar electrode and RF equipment).
f) Components or accessories that can be sold separately should be identified.
g) If approved by the regulator, provide the approval number and identification for each component or accessory.
h) If the device is to be sterilized, an indication of who is to perform the sterilization and by what method (e.g. EtO, gamma irradiation, dry heat) OR an affirmative statement that the device is non-sterile when used.

NOTE: The validation report is not expected be presented at this point, only the device sterility condition shall be indicated here. If appropriate, for the validation report, see Chapter 3 – Non-Clinical Studies.
i) Summary of the composition of the device including, at minimum, the material specification and/or chemical composition of the materials that have direct or indirect contact with the user and/or patient. When required, full details to support how these specifications are met are to be provided in CH3.5.02 – Chemical/Material Characterization.

NOTE: If applicable, chemicals may be identified using either the IUPAC (International Union of Pure and Applied Chemistry) or the CAS (Chemical Abstract Service) Registry number. Reference to applicable material standards may also be useful in this description.
j) If applicable, indication of biological material or derivate used in the medical device, including: origin (human, animal, recombinant or fermentation products or any other biological material), source (e.g. blood, bone, heart, any other tissue or cells), and the intended reason for its presence and, if applicable, its primary mode of action.
k) If the device contains an active pharmaceutical ingredient (API) or drug, an indication of the substance, should be provided. This should include its identity and source, and the intended reason for its presence and its primary mode of action.

NOTE: The sponsor/applicant should explicitly address any existing regional regulatory guidance related to the comprehensive device description and principles of operations provided in this section regarding the subject device

ANVISA : a) Some accessories may request independent submission at ANVISA. Especially when it is considered a medical device by itself and is not of exclusive use of the medical device to be used in combination. For this accessories shall be identified and their registration/notification number in ANVISA provided.
b) For invasive, inhaled, ingested product, a list of ingredients, including their quantity, purity and or other relevant information.

USFDA : PMA : Color Additive information per item A 6.a.ii in Appendix A of the Acceptance and Filing Reviews for Premarket Approval Applications (PMAs): Guidance for Industry and Food and Drug Administration Staff Guidance; 21CFR 814.20(f)

TGA : In the case of products that incorporate a medicinal substance, a rationale of applicability of medical device regulations should be included.

UE : For invasive, inhaled, ingested product, a list of ingredients, including their quantity, purity and or other relevant information to determine potential pharmaceutical supportive action.

JP : Explain that the established product specifications are necessary and sufficient to ensure the efficacy, safety, and quality of the product.

DT UE : a) et une description générale du dispositif,
d) Les principes de fonctionnement du dispositif et son mode d’action, démontré scientifiquement si nécessaire;
i) Une description ou la liste complète des différentes configurations ou variantes du dispositif qui doivent être mises à disposition sur le marché;
f) La classe de risque du dispositif et la justification de la ou des règles de classification appliquées conformément à l’annexe VIII;
e) Les raisons pour lesquelles le produit constitue un dispositif médical;
g) Une explication de toute caractéristique innovante;
h) Une description des accessoires de dispositif
h) Une description des autres dispositifs et des produits autres que des dispositifs destinés à être utilisés en combinaison avec le dispositif;
j) Une description générale des éléments fonctionnels clés tels que les pièces ou composants

2.04.02. Description de l’emballage des dispositifs

📚 : PRO.C&D
§: Données de sortie de la conception

IMDRF : a) Information regarding the packaging of the devices, including, when applicable, primary packaging, secondary and any other packaging associated;b) Specific packaging of accessories marketed together with the medical devices shall also be described;c) If the user needs to package the medical device or its accessories before they perform sterilization, information about the correct packaging (e.g. material, composition, dimension) should be provided.

2.04.03. Historique du développement

📚 : PRO.C&D
§:

IMDRF : For any device versions/prototypes referenced in the evidence presented in the submission, a table describing the version/name, with 4 columns (Device Name and/or Version; Description of changes from previous row; motivation for the change; list of verification/validation activities, including clinical studies, conducted using this version).

For any design verification or validation activities presented in this submission (including clinical studies) performed on any earlier versions of the subject device, include a justification for why the changes do not impact the validity of the data collected under those activities in supporting the safety and effectiveness of the final device design.

USFDA : 510k : It is highly recommended that the following be provided for a device that has received prior 510(k) clearance: either a description of all changes made to the device since the last 510(k) clearance or a statement that no changes have been made

JP : a) State the beginning and ending dates of non-clinical and clinical studies and the rationale for the decision of advancement from non-clinical studies to clinical studies.
b) Describe work allocation in the development process (i.e. what commercial or non-commercial entities were involved at what stages of development).

2.04.04. Référence et comparaison avec des dispositifs similaires

📚 : DOC.DGR
§: DM aux finalités thérapeutiques comparables, etDM aux principes de fonctionnement comparables

IMDRF : a) A list of similar devices (available on local and international market) and/or previous generation of the devices (if existent) relevant to the submission. This should include any similar/previous generation devices that were previously reviewed and refused by the subject regulator.b) Description of why they were selected.c) A key specification comparison, preferably in a table, between the references (similar and/or previous generation) considered and the device.

HC : a) If the application is an amendment to a licenced device or is based on a modification of a licensed device, a description of the modifications is required (e.g., changes in design, performance, and indications). b) Comparisons can be used to support the safety and effectiveness of the device if they are made to a currently licensed device in Canada. If this method is used, ensure the Canadian Medical Device Licence Number of the comparator is stated. The comparison device does not need to be manufactured by the same manufacturer.

DT UE : b) Une présentation générale des dispositifs similaires identifiés disponibles sur le marché de l’Union ou le marché international, s’il en existe.

2.04.05. Discussions sur l’équivalence substantielle

📚 : RPT.EVL.CLI
§: Démonstration de l’équivalence

USFDA : 510k : Identify the predicate device(s), and optionally reference devices
i. 510(k) number, trade name and model number
ii. Ensure the identified predicate device(s) is consistent throughout the submission (i.e., Substantial Equivalence discussion are the same as listed in the 510k) summary and the same as those used in comparative performance testing).
b) Include a comparison of indications for use and the technology (including features materials and principles of operation) between the predicate device(s) and subject device(s).
c) Include an analysis of why any differences between the subject device(s) and the predicate device(s) do not render the subject device(s) Not Substantially Equivalent, affect safety or effectiveness or raise different questions of safety and effectiveness.

2.04.06. et/ou de générations précédentes

📚 : PLN.EVL.CLI
§: Historique du dispositif

DT UE : a) Une présentation générale de la ou des générations précédentes du dispositif produites par le fabricant, s’il en existe;

2.04.07. IUD*

📚 : PRO.IDT
§: IUD

DT UE : b) L’IUD-ID visé à l’annexe VI, partie C, attribué par le fabricant au dispositif en question, dès lors que l’identification du dispositif est basée sur un système IUD, ou une autre identification claire au moyen d’un code de produit, d’un numéro dans le catalogue ou d’une autre référence non équivoque permettant la traçabilité;

2.05. Indications d’utilisation et/ou d’utilisation prévue et contre-indications

2.05.01. Utilisation prévue, finalité prévue

📚 : DOC.DGR
§: Utilisations prévues

IMDRF : This section should include, as appropriate:a) Intended Use: The statement of intended use should specify the therapeutic or diagnostic function provided by the device and may describe the medical procedure in which the device is to be used (e.g. Diagnosis in vivo or in vitro, treatment monitoring rehabilitation, contraception, disinfection).b) Intended Purpose: What is expected with the use of this medical device? Which results are expected?c) Intended user and skills/knowledge/training that the user should have to operate or use the device.d) Identify if the device is intended for single or multiple usee) Indications for Use:i. Disease or medical condition that the device will diagnose, treat, prevent, mitigate, or cure, parameters to be monitored and other considerations related to indication for use.ii. If applicable, information about patient selection criteria.iii. If applicable, information about intended patient population (e.g. adults, pediatrics or newborn) or a statement that no subpopulations exist for the disease or condition for which the device is intended.NOTES: i. The statements of intended use and purpose and the intended user and indications for use must be as presented in the labelling.ii. If more than one device is included, the information should be provided for each device

ANVISA : Indications for use shall include in which part of the human body the device is intended to be used (e.g. central nervous system, central circulatory system, teeth, eye surface, injured skin).

DT UE : 1.1. Description et spécification du dispositif,a) y coc) La population de patients visée, l’affection à diagnostiquer, à traiter et/ou à contrôler et d’autres considérations telles que les critères de sélection applicables aux patients,mpris sa destination,a) et les utilisateurs auxquels il est destiné;

2.05.01. Indications d’utilisation*

📚 : PLN.EVL.CLI
§: Utilisations prévues

DT UE : c) les indications

2.05.02. Environnement / cadre d’utilisation prévu

📚 : DOC.DGR
§: Utilisations prévues

IMDRF : a) The setting where the device is intended to be used (e.g. domestic use, hospitals, medical/clinical laboratories, ambulances, medical/dental offices). Multiple options can be indicated.b) If applicable, environmental conditions that can affect the device’s safety and/or performance (e.g. temperature, humidity, power, pressure, movement).

USFDA : FDA includes this information in the indications for use and product labelling

DT UE : 1.1. Description et spécification du dispositif

2.05.03. Utilisation pédiatrique

USFDA : PMA : a) Description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose or cure,
b) The number of affected pediatric patients, as a whole and within each pediatric subpopulation.
OR
c) Statement that no pediatric subpopulation exists for the disease or condition for which the device is intended.

2.05.04. Contre-indications d’utilisation

📚 : DOC.DGR
§: Contre indications, effets secondaires, effets physiologiques non manifestes

IMDRF : If applicable, specify the disease or medical conditions that would make use of the device inadvisable due to unfavorable risk/benefit profile.
NOTE: The statement if contraindications for the device must be as presented in the labelling.

USFDA : FDA includes this information in the indications for use and product labelling

DT UE : c) les contre-indications

2.06. Historique de commercialisation

2.06.01. Historique du marché mondial

📚 : PLN.EVL.CLI
§: Historique du dispositif

IMDRF : a) Up to date indication of the markets (all countries or jurisdictions) where the device is approved for marketing, including any marketing under compassionate use regulations.
b) Should include history of the marketing of the device by any other entity in as much detail as possible, acknowledging that detailed information may not be available in all cases.
c) If the subject device is different in any way (e.g. design, labelling, specifications) from those approved or marketed in other jurisdiction, the differences should be described.
d) The month and year of market approval in each country or jurisdiction where the device is marketed. If the device has been marketed for greater than 10 years, a statement of greater than 10 years can be made.
e) For each of the markets listed in (a) above, and statement of the commercial names used in those markets OR a clear statement that the commercial names are the same in all jurisdictions.
f) State the date of data capture for the market history data
g) If the subject device has been the subject of any previous compassionate use and/or clinical trials this should be identified and, if applicable, relevant reference numbers provided.

ANVISA : If there is any approval number, given to the device by the regulator authority of the markets (country or jurisdictions) where the device is already marketed, this identification must be informed.

TGA : Any notifications to foreign regulators of substantial change to the device

UE : The commercial names used by the Original Equipment Manufacturer in case of Own Brand Labelling should be identified.

HC : If there is any approval number, given to the device by the regulator authority of the markets (country or jurisdictions) where the device is already marketed, this identification must be informed.

a) Marketing history of a Health Canada licensed, previous version of the device can sometimes be used in support of safety or effectiveness of the subject device. If this is to be the case, then the name of the comparator, its medical device licence number and the number of units sold should be provided.

HC NOTE: In this context, compassionate use includes any Special Access Authorizations.

2.06.02. Rapports d’incidents mondiaux et rappels

📚 : PLN.EVL.CLI
§: Connaissances actuelles/Incidents

IMDRF : a) List adverse events/incidents associated with the device and a statement of the period associated with this data.b) If the number of adverse events is voluminous, provide a summary by event type that state the number of reported events for each event type. c) List of the medical device recalls and/or advisory notice, and a discussion of the handling and solution given by the manufacturer in each case. d) A description of any analysis and/or corrective actions undertaken in response to items listed above.NOTESi. It is acknowledged that the definition of recall may vary from one jurisdiction to another; hence this heading is labelled as regionally focused (RF).

USFDA : 510k (note) : Include when submitting a 510(k) to implement a design change to address a recall of a device in the US

HC : a) The jurisdiction(s) associated with the incident should be clearly indicated. b) Incidents should include any Canadian incidents through SAP or other previous Canadian applications, if known.c) If marketing history is presented for a previously licensed device, then the associated recalls, and incident reports for that device should also be summarized here.

2.06.03. Taux de ventes,

📚 : PRO.SAC
§: Estimation du nombre de dispositifs en utilisation sur le marché

IMDRF : a) A summary of the number of units sold in each country/region and a statement of the period associated with this data.b) Provide the rates calculated for each country/region, for example:i. Incident rate = # adverse events/incidents divided by # units sold x 100ii. Recall rate = # recalls divided by # units sold x 100Rates may be presented in other appropriate units such as per patient year of use or per use. In this case, methods for determining these rates should be presented and any assumptions supported.c) Critical analyses of the rates calculated (e.g. Why are they acceptable? How do they break down in terms of incidents? Is there some outlier data that has driven the rates up? Are there any trends associated with any sub-groups of the devices that are subject of the submission (e.g. size, version)?).NOTESi. It is acknowledged that the definition of recall may vary from one jurisdiction to another; hence this heading is labelled as regionally focused (RF).ii. Sales in this context should be reported as the number of units sold.iii. The summary of sales should be broken down by components when appropriate.

2.06.03. Incidents et de rappels *