Ii Notice This report is being disseminated by the Department of Energy. As such, this document was prepared in compliance with Section 515 of the Treasury and General Government Appropriations Act for Fiscal Year 2001 (Public. Guidance Document: Guidance on supporting evidence to be provided for new and amended licence applications for Class III and Class IV medical devices, not including In Vitro Diagnostic Devices (IVDDs) July 5, 2012. Guidance on supporting evidence to be provided for new and amended licence applications for Class III and Class IV medical devices, not including In Vitro Diagnostic Devices (IVDDs) . A draft version of this guidance was first released for consultation in 2. Comments from stakeholders have been considered in producing this final version. This document is intended to aid manufacturers in the preparation of scientific information to be provided in support of Class III and Class IV non- in vitro diagnostic device licence applications and application amendments filed pursuant to the Canadian Medical Devices Regulations. An updated guidance on In Vitro Diagnostic Devices (IVDDs) will be made at a future date. Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices was developed by the Global Harmonization Task Force (GHTF) and adopted by Health Canada for use in Class III and Class IV premarket device licence applications and licence amendment applications. This guidance is for those manufacturers who choose not to submit a premaket licence application or amendment application for Class III and IV medical device using the STED- based application. The implementation date is July 4, 2. Please note that once implemented, failure to file an application in either the format outlined in this guidance or in the STED- based format may result in the rejection of the application at the screening stage if the content cannot be appropriately assessed.
For more information on this guidance document, please contact: Manager, Device Evaluation Division, Medical Devices Bureau. Therapeutic Products Directorate. Health Canada. 29. Baseline Road. Tower BAddress Locator 3. AOttawa, Ontario. K1. A 0. K9. Phone: 6. Fax: 6. 13- 9. 57- 9. Email: DED. Guidance documents also provide assistance to staff on how Health Canada mandates, and objectives should be implemented in a manner that is fair, consistent and effective. Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they, are supported by adequate justification. Alternate approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met. As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, in order to allow the Department to adequately assess the safety, efficacy or quality of a therapeutic product. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented. This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable guidance documents. Table of Contents. Introduction. The purpose of this guidance document is to elaborate on the scientific and clinical content to be included in Class III and Class IV (non- IVDD) medical device licence applications and medical device licence amendment applications, in accordance with the medical devices licensing provisions in section 3. Medical Devices Regulations (Regulations). All Class III and Class IV medical devices require a review of submitted evidence of safety and effectiveness before their licence applications can be finalized. The content elaborated upon in this guidance document is to be submitted for review in addition to the general data elements listed in paragraphs 3. Regulations, which are required for all medical device licence applications. This guidance document outlines the technical content commonly accepted in support of the safety and effectiveness of a subject device. Policy Objectives. To facilitate the submission to Health Canada of scientific and clinical content for medical device licence applications and licence amendment applications for Class III and Class IV medical devices filed pursuant to sections 3. Regulations. 1. 2 Policy Statements. This guidance document is to be used in the preparation of Class III and Class IV non- in vitro diagnostic devices (non- IVDD) medical device licence applications and licence amendment applications should the manufacturer choose not to use the STED- based application process. Failure to file an application in either the format outlined in this guidance or in the STED- based format may result in the rejection of the application at the screening stage. Scope and Application. This guidance document is intended to aid manufacturers and regulatory correspondants in understanding the content expectations for Class III and IV non- IVDD medical device licence applications or licence amendment applications. This document provides details regarding the scientific and clinical content to be provided in support of applications for Class III and Class IV device licences. The latter are described in the document entitled Guidance On How to Complete the Application for a New Medical Device Licence, GD0. An updated guidance on IVDDs will be made available at a future date. The report advocated two principles: (1) the level of scrutiny afforded a device should be dependent upon the hazard that the device presents; and (2) the safety and effectiveness of the device can best be assured through a balance of quality systems requirements, premarket scrutiny and postmarket surveillance. The technical documentation required for premarket conformity assessment is extracted from the complete set of on- site quality systems records, including design input requirements, design output documentation, verification and validation documents and production and process documents. Guidance for Implementation. Access to Information. Information provided to Health Canada by manufacturers is subject to the provisions of the Access to Information Act. Application information containing trade secrets or confidential scientific, technical, commercial or financial information is protected from disclosure by this Act. According to TPD policy, information regarding device licence applications that have been received or are being processed is also considered confidential. Once a licence has been granted, basic information about a device, such as that listed in section 3. Regulations, is considered public information. Format of Application. This section outlines the format for Class III and Class IV non- in vitro diagnostic medical devices licence applications and licence amendment applications. The application's Table of Contents should use the headings provided in Tables 1 and 2, with clear references to the corresponding page numbers that contain the relevant information. If no information is available or required under a specific heading, that section of the application should be marked . The Administrative Information is detached from the Application and/or Amendment prior to being reviewed. For medical device licence amendment applications, a full device description and the intended use (or indication for use) statement are required in addition to those sections that are relevant to the change. Where information under a specific heading remains unchanged, that section or subsection of the application should be marked . The cross- reference should include the Canadian licence number, device name and where possible application ID and manufacturer's name as it appears in the previously filed application. Electronic Applications. Health Canada is developing a phased migration plan from the current paper- based application to an electronic- based application for medical devices. To facilitate this transition, applicants are encouraged to submit premarket review documents for Class III and IV medical device licence applications and amendment applications in electronic format, as well as the required paper copy. Electronic documents should be provided on compact discs (CDs) or digital video discs (DVDs). Please refer to the current Health Canada Notice, Guidance for Industry: Preparation of a Premarket Review Document in Electronic Format for a Class IV Medical Device Licence Application for additional details. The electronic- based application should also include a Letter of Attestation confirming that the content of the electronic application is identical to that of the accompanying paper copy. The Letter of Attestation should be on the manufacturer's letterhead and signed and dated by a senior official of the manufacturer. Applicants should consult the updated notice on the preparation of a premarket review document in electronic format for a sample Letter of Attestation and electronic file requirements. Abbreviations and Acronyms. BGTDBiologics and Genetic Therapies Directorate. CASChemical Abstract Service. CMDCASCanadian Medical Devices Conformity Assessment System. CSACanadian Standards Association. CTOCells, Tissue and Organs. Do. CDeclaration of Conformity. HPFBHealth Products and Foods Branch. HPLCHigh Performance Liquid Chromotography. ICHInternational Conference on Harmonisation. ISOInternational Organization for Standardization. IUPACInternational Union of Pure Applied Chemistry. IVDDIn Vitro Diagnostic Device. LALLimbus Amebocyte Lysate. MDBMedical Devices Bureau. MDLMedical Devices Licence. MSDSMaterial Safety Data Sheets. SALSterility Assurance Level. SAPSpecial Access Programme. SDS- PAGESodium Dodecyl Sulfate Polyacrylamide Gel Electrophoresis. TPDTherapeutic Products Directorate. TSETransmissible Spongiform Encephalopathies. Definitions. In Vitro Diagnostic Device is a medical device that is intended to be used in vitro for the examination of specimens taken from the body.
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