csdt common submission dossier template ˜ ˜˜˜ ˜ - fda all rights reserved health sciences...
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1 All Rights Reserved Health Sciences Authority
Dr Jiang Naxin Health Sciences Authority, Singapore
9 October 2012
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in vitro Diagnostic Medical Devices
CSDT Common Submission Dossier Template
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Scope
§ Overview
§ Executive Summary
§ Other CSDT Sections
§ Submission Requirements
§ Q&A
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DE001
DE002
DE003
Model 001 Model 002 Model 003 Model 004
DE003
C-12345
1 grouped product registration application
1 dossier
Single OR
Multiple SMDR listings
Multiple product models
DE001
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ASEAN Common Submission Dossier Template (CSDT)
Includes elements of the GHTF Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)
Intended as a harmonised format for pre-market
submission in ASEAN member economies
Product Registration submissions to HSA must be prepared in the ASEAN CSDT format.
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Main Sec�ons of the CSDT
Executive Summary Relevant Essential Principles and Method Used to
Demonstrate Conformity Device Description Summary of Design Verification and Validation
Documents Device Labeling Risk Analysis Manufacturer Information
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Scope
§ Overview
§ Executive Summary
§ Other CSDT Sections
§ Submission Requirements
§ Q&A
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Execu�ve Summary
Overview Commercial marketing history Intended uses and indications Regulatory approval or marketing clearance obtained Status of pending regulatory approval Important safety or performance information
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Regulatory Approval or Marketing Clearance obtained Ø Registration status in reference agencies
Execu�ve Summary
Reference agency
Intended use submitted for registration
Indications of use submitted for registration
Registration status (e.g. pending approval, rejected or withdrawn)
Reason of rejection or withdrawal
Australia - TGA
Canada – Health Canada
European Union – CE marked as Medical Device
Japan – MHLW
US - FDA
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Important Safety and Performance related Information Ø Summary of adverse events and FSCAs
Execu�ve Summary
Description of adverse event
Frequency of occurrence (number of reports/total units sold)
Date of FSCA/ Recall Reason for FSCA / Recall
Countries where FSCA/ Recall was conducted
Year Product Name FSCA Description
Actions/comments Status
2009 XXXX Device Missing application software
Recall Close
2008 Software Application Card
Replacing old cards
Cards exchange Close
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Main Sec�ons of the CSDT
Executive Summary Relevant Essential Principles and Method Used to
Demonstrate Conformity Device Description Summary of Design Verification and Validation
Documents Device Labeling Risk Analysis Manufacturer Information
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Relevant Essen�al Principles and Method Used to Demonstrate Conformity
Essential Principles and Evidence of Conformity
Ø Essential Principles (EPs) of Safety and Performance comprises of:
- General requirements of safety and performance that apply to ALL medical devices
- Design and manufacturing requirements of safety and performance, relevant to specific medical device
No. Essen�al Principles – General Requirements
Applicable to the Device?
Method of Conformity
Iden�ty of Specific Documents
1 Medical Devices should be designed and manufactured in such a way that, when used under the condi�ons and for the purposes intended and, where applicable, by virtue of the technical knowledge, experience, educa�on or training of intended users, they will not compromise the clinical condi�on or the safety of pa�ents, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use cons�tute acceptable risks when weighed against the benefits to the pa�ent and are compa�ble with a high level of protec�on of health and safety.
Yes Quality System Standard:
-‐ ISO 13485: 2003
Risk Management Standard:
-‐ ISO 14971:2007
Design Control Procedures:
-‐S83782
Mfg A Ltd Corporate Quality Manual
ISO 13485 cer�ficate No. 135
Risk Management Report
Design Specifica�ons 322/2005/08
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Scope
§ Overview
§ Executive Summary
§ Other CSDT Sections
§ Submission Requirements
§ Q&A
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Main Sec�ons of the CSDT
Executive Summary Relevant Essential Principles and Method Used to
Demonstrate Conformity Device Description Summary of Design Verification and Validation
Documents Device Labeling Risk Analysis Manufacturer Information
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Ø Manufacturer determines the applicable EPs and demonstrates conformity to each applicable EP
Ø Generally documented in a checklist format
Reference: GN-16 Guidance on Essential Principles for Safety
and Performance of Medical Devices. http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/medical_devices/regulatory_guidances.html
Relevant Essen�al Principles and Method Used to Demonstrate Conformity
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Device Descrip�on General description Principles of operation Risk class and applicable rule (GN-13, GN-14
Guidance) Description of accessories or products which are
used in combination with the device List of configurations or variants Description of key functional elements, e.g. components, software, composition. Labeled pictorial representation, if appropriate Explanation of any novel features
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List of Configura�ons
Present your devices/models/components/accessories clearly
Well Organized list of configurations = Correct SMDR listing
Avoid Repetitions in models
Organize components that are intended to be used together
For IVDs, list the controls, calibrators and analyzers with the corresponding reagent kits for easy identification
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Device Descrip�on
Intended use Indications Instructions of use Contraindications Warnings Precautions Potential adverse effects Alternative therapy
Instructions For Use
(IFU)
Sections not included in IFU must be addressed separately in the dossier
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Main Sec�ons of the CSDT
Executive Summary Relevant Essential Principles and Method Used to
Demonstrate Conformity Device Description Summary of Design Verification and Validation
Documents Device Labeling Risk Analysis Manufacturer Information
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Pre-‐clinical studies -‐ IVD Analytical Sensitivity Analytical Specificity Interfering Substances Precision (Repeatability/ Reproducibility) Linearity (Reportable Range) Trueness Recovery Stability of reagent Specimen type and storage recommendations Potential Carryover
Traceability & Expected Values (Controls, Calibrators, Methods)
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Clinical studies -‐ IVD Performance evaluation studies using human specimens
Clinical Sensitivity Clinical Specificity Performance evaluation studies in comparison to a
predicate/ well-established device Clinical Cut-off Reference Interval For self-testing and point-of-care IVD, performance
evaluation when used by the target users e.g. lay person in case of self-testing IVD
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Main Sec�ons of the CSDT
Executive Summary Relevant Essential Principles and Method Used to
Demonstrate Conformity Device Description Summary of Design Verification and Validation
Documents Device Labeling Risk Analysis Manufacturer Information
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Copies (in original colour) of: Ø Labels on the device and its packaging
ü For all levels of packaging ü Artwork ü If representative label provided for variants, variable fields on
artwork to be annotated
Ø Instructions for use (including operating manual and user manual)
Ø Patient information leaflet (where applicable)
Ø Promotional material (including brochures and catalogues)
Device Labelling
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Main Sec�ons of the CSDT
Executive Summary Relevant Essential Principles and Method Used to
Demonstrate Conformity Device Description Summary of Design Verification and Validation
Documents Device Labeling Risk Analysis Manufacturer Information
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To conduct risk analysis and risk management activities according to the ISO 14971: 2007 (recommended)
Provide the risk management report containing details on risk analysis, risk evaluation, risk control and mitigation as conducted for the medical device
Risk Analysis
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Main Sec�ons of the CSDT
Executive Summary Relevant Essential Principles and Method Used to
Demonstrate Conformity Device Description Summary of Design Verification and Validation
Documents Device Labeling Risk Analysis Manufacturer Information
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Manufacturer
Ø Identify sites for design and manufacturing activities – including OEM manufacturers
Ø Provide Quality Management System (QMS) certificates for design and manufacturing sites (including OEM) as an Annex to CSDT
Ø Manufacturing Process (flow chart)
Manufacturer Informa�on
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QMS Certificate – ISO 13485
Manufacturer Informa�on
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Scope
§ Overview
§ Executive Summary
§ Other CSDT Sections
§ Submission Requirements
§ Q&A
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IVD -‐ Data Requirements CSDT Sec�on No.
Heading Abridged Submission Full Submission
Class B Class C Class D Class B Class C & D
3.0 Execu�ve Summary
Required 4.1.1 Essen�al Principles and
Evidence of Conformity
4.2 Device Descrip�on
4.4 Device Labelling
4.5.1 Risk analysis May be Required for certain medical devices
Required
4.6.1 Manufacturer Informa�on and Manufacturing Process Required
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IVD -‐ Data Requirements CSDT Sec�on No.
Heading Abridged Submission Full Submission
Class B
Class C
Class D
Class B
Class C & D
4.3.1 Pre-‐clinical studies Analy�cal Sensi�vity and Specificity Linearity and Reportable Range Precision and Trueness Stability of reagent Specimen type and Storage Biological material informa�on Instruments/Analyzers -‐ Poten�al Carryover -‐ linearity, Precision -‐ So�ware Verifica�on & Valida�on Traceability & Expected Values (Controls, Calibrators, Methods)
Summary Detailed informa�on
4.3.1
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IVD -‐ Data Requirements CSDT Sec�on No.
Heading Abridged Submission Full Submission
Class B
Class C
Class D Class B
Class C & D
4.3.2 Clinical evidence
§ Diagnos�c Sensi�vity and Specificity
§ Comparison Studies using Clinical Specimens to performance of predicate device
§ Comparing device performance to accepted diagnos�c procedures
Summary Detailed informa�on
§ Performance evalua�on studies for the normal condi�ons of use -‐ for self-‐tes�ng and near pa�ent tes�ng
Summary Detailed informa�on
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Organiza�on of the Dossier Certificates/Reports/Supporting Documents
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Scope
§ Overview
§ Executive Summary
§ Other CSDT Sections
§ Submission Requirements
§ Q&A
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Thank You!