Content of an IVD Technical Dossier to Register a Device to Japan

P

Pythagore

Hello everybody,
I am searching details on the content of a IVD technical dossier to register a device to Japan.
To be more specific: all the data that are necessary and their presentation (reproducibility, comparison method, LoB, LoD, sensitivity ...).
Thank you very much for all your help.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
T New guidance "Content of Premarket Submissions for Device Software Functions" IEC 62304 - Medical Device Software Life Cycle Processes 5
D How to address the content deviation of 'cannot apply criteria of risk acceptability prior to...' ISO 14971 - Medical Device Risk Management 1
Watchcat New Draft Guidance on Content of Premarket Submissions for Software Device "Functions" Other US Medical Device Regulations 2
Miner Reported content: Post in thread 'Form of real time study for establish shelf time' Document Control Systems, Procedures, Forms and Templates 1
shimonv Document Control Procedure Header Content Document Control Systems, Procedures, Forms and Templates 4
S Looking for Quality Content to Build Medical Device Curriculum - Concept to Commercialization Training - Internal, External, Online and Distance Learning 4
A Several sections of traditional 510(K) have the same or similar requirement of content. US Food and Drug Administration (FDA) 4
F Calibration certificate content - Average Value and True Value ISO 17025 related Discussions 6
Raffy ISO 14001 9.2.2 Internal Audit Programme Content Internal Auditing 10
F Control of medical device IFU content Other Medical Device and Orthopedic Related Topics 3
U Manufacturing solutions and keeping records on quality Content CE Marking (Conformité Européene) / CB Scheme 3
L Label Content Requirements under MDR regulation EU Medical Device Regulations 5
dgrainger MHRA - Creation of new UK Responsible Person section with added content. Medical Device and FDA Regulations and Standards News 0
L Content of Declaration of conformity (MDR) EU Medical Device Regulations 1
E Calibration Certificate Content Requirements General Measurement Device and Calibration Topics 3
G ISO 9001 - 9.3.1 Management Review - Content and Frequency Management Review Meetings and related Processes 12
Dean Bell QMS Content for one-man consultancy Consultants and Consulting 19
I Environmental Policy Content - ISO 14001 Clause 5.2 ISO 14001:2015 Specific Discussions 2
F Organising IQ, OQ and PQ content in a "smart" way Qualification and Validation (including 21 CFR Part 11) 3
M Informational USFDA final guidance – Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions Medical Device and FDA Regulations and Standards News 0
L Class IIa Medical Device, CE Mark & 510k - Labeling Content CE Marking (Conformité Européene) / CB Scheme 4
M Informational EU – MDCG 2018-8 – Guidance on Content of the certificates, voluntary certificate transfers Medical Device and FDA Regulations and Standards News 0
L EU-MDR-Annex I - 10.4 (CMR & Endocrine-disrupting properties) - Labeling Content EU Medical Device Regulations 5
M FDA News USFDA Final Guidance – Manufacturing Site Change Supplements: Content and Submission Medical Device and FDA Regulations and Standards News 1
G Regulatory requirements for secondary packages in terms of label content Other Medical Device Regulations World-Wide 2
M Is referenced content sufficient to meet record content requirements? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S Corrections and Removals - Fiber Content in our textile products was incorrect Other US Medical Device Regulations 1
D Technical file structure/content requirements for Class IIa devices & new MDR EU Medical Device Regulations 14
H Numbering for documents with same content but different language ISO 13485:2016 - Medical Device Quality Management Systems 4
R ISO 9001:2015 Transition Quality Manual Update - Redundant Content ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
C Software for Medical Devices - Requirements Content for compliance with IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 1
V Periodic Audit Trail Review - Scope, Content & Frequency Qualification and Validation (including 21 CFR Part 11) 13
Q Changing Terminology in ISO 9001:2015 - Documentation Content ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Work Instruction Content or Sequence Changes and Operation Numbering Document Control Systems, Procedures, Forms and Templates 3
C AS9102 FAIR Form 1 Content Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
Ronen E FDA issues draft guidance on form & content of UDI Other US Medical Device Regulations 0
T ISO 62304 - Software requirements content IEC 62304 - Medical Device Software Life Cycle Processes 3
H Cause analysis for an Audit Finding - Purchasing Procedure Content ISO 13485:2016 - Medical Device Quality Management Systems 9
O Question on the Content of an Abbreviated 510(k) US Food and Drug Administration (FDA) 1
Q Scope in procedure and content for 7.6 Monitoring and Measuring Equipment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
A API (American Petroleum Institute) Design Package Content Requirements Oil and Gas Industry Standards and Regulations 1
S Required PFMEA Content - Final QC Inspection FMEA and Control Plans 7
R Inconsistent Form Content including User Changes Document Control Systems, Procedures, Forms and Templates 3
B External Label Content of multi-device (sterile and nonsterile) EU Medical Device Regulations 3
J Document Control Features (Document Content Requirements) and 21 CFR 820.40 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M Scope content of TS 16949 certificate under Rules 4 IATF 16949 - Automotive Quality Systems Standard 6
D Class II Disposable Medical Device Label Content Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Change in wording, but not content - Special 510k? Other US Medical Device Regulations 2
D ESD Policy Content Best Practices Manufacturing and Related Processes 8
S Glove Protein Content in μg/dm2 to μg/g and Powder Amount mg/dm2 to mg/glove Other Medical Device Regulations World-Wide 4

Similar threads

Top Bottom