1. RENSEIGNEMENTS ADMINISTRATIFS RÉGIONAUX
1.01. Lettre d’accompagnement
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.
ANVISA : a) Receipt of the User Fee payment. Information about User Fee available at:
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
📚 : 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
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 .
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.