Document retention Policy for Japan's PMDA

bill.Kal

Involved In Discussions
#1
hi Medtech Community,
Who can help me retrieve the following in info?
  1. What is the document retention policy when submitting documentation to launch a medical device in Japan?
  2. Is there a difference for clinical investigations?
Thank you for your help!
 
Elsmar Forum Sponsor

ECHO

Involved In Discussions
#2
What is the document retention policy when submitting documentation to launch a medical device in Japan?
I believe they follow ISO 13485.
Here is an article about record retention for ISO 13485:
ISO 13485 Quality Record Retention Period

Is there a difference for clinical investigations?
I assumed you mean compared to FDA. Short answer is yes. Long answer is it really depends on your product.
Try this first. https://www.pmda.go.jp/files/000153732.pdf
 
Thread starter Similar threads Forum Replies Date
B Document Retention Policy for NMPA China Medical Device Regulations 1
D Document Retention Policy IATF 16949 - Automotive Quality Systems Standard 5
Marc FDA Document and Records Retention Policy Requirements US Food and Drug Administration (FDA) 4
M Medical and Administration department Document and Record Retention policy Document Control Systems, Procedures, Forms and Templates 8
B Document Retention period for MHRA submission UK Medical Device Regulations 0
H Document retention period Canada Medical Device Regulations 2
Q ISO 9001/IATF 16949 Audit Finding Question - Document Retention IATF 16949 - Automotive Quality Systems Standard 11
R Document Retention - Discard hard-copies after scanning? ISO 13485:2016 - Medical Device Quality Management Systems 2
D PMA A&P Document (i.e. Promotional Brochures, Flyers) Retention Requirements Other US Medical Device Regulations 10
B The Reason and Effectiveness of Retention Document - CB Audit Results ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Questions pertaining to our last audit - Fix or Minimum Document Retention time? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
E Document Retention Schedule Requirements per ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 4
R ISO/TS 16949 Document Retention Guidelines IATF 16949 - Automotive Quality Systems Standard 23
J Medical Device Document Retention Time Requirements ISO 13485:2016 - Medical Device Quality Management Systems 4
K 93/42/EEC Obsolete Document Retention requirements - New timeframe? Document Control Systems, Procedures, Forms and Templates 3
Jerry Eldred Document Retention of Obsolete Calibration Procedures General Measurement Device and Calibration Topics 4
V Hard copies from 10-20 years ago - Document Control and Retention Times question Document Control Systems, Procedures, Forms and Templates 19
A Obsolete Document Retention Requirements ISO 13485:2016 - Medical Device Quality Management Systems 4
B PPAP Document Submission and Retention requirements APQP and PPAP 21
R Document Retention - Customers who each have different document retention periods Document Control Systems, Procedures, Forms and Templates 2
E Document and record retention periods for the different OEM's Customer and Company Specific Requirements 2
S Determining Document Retention Times QS-9000 - American Automotive Manufacturers Standard 3
R Document Retention Requirements QS-9000 - American Automotive Manufacturers Standard 4
T Ensuring Document Review AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
T TipQA Document Management AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
A Document control system for QMS in Google Drive? Document Control Systems, Procedures, Forms and Templates 6
M On-demand EU MDR Compliance toolkit with online training courses, templates & document management system Training - Internal, External, Online and Distance Learning 0
C Document Record/Template Minimum Requirements ISO 13485:2016 - Medical Device Quality Management Systems 3
E Do anyone have document of automotive production risk and control of risk? Lean in Manufacturing and Service Industries 1
Q Document representation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J Document Control of Online Management Software ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
W Document control Document Control Systems, Procedures, Forms and Templates 10
D Increasing efficiency - Capt. Proj. Document Review Matrix Document Control Systems, Procedures, Forms and Templates 4
A ISO 9001:2015 8.5.6 and 7.5.3 Document Control Questions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
qualprod Sheets into a spreadsheet document control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
J Document Changes that don't have to be approved Document Control Systems, Procedures, Forms and Templates 11
D Electronic Document Management System ISO 13485:2016 - Medical Device Quality Management Systems 16
M Document Control - Applying Suitable Identification to Obsolete Documents ISO 13485:2016 - Medical Device Quality Management Systems 5
D Document Control Question involving DocuSign US Food and Drug Administration (FDA) 6
M Document Control ISO and FDA ISO 13485:2016 - Medical Device Quality Management Systems 7
D Document Change Approval ISO 13485:2016 - Medical Device Quality Management Systems 6
R Does anyone use iQMS for their ISO based document control? Manufacturing and Related Processes 1
C Document Identification Question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
A If document coding is change will there be a revision Document Control Systems, Procedures, Forms and Templates 1
S Document numbering question? ISO 13485:2016 - Medical Device Quality Management Systems 7
R Quality policy review document IATF 16949 - Automotive Quality Systems Standard 3
dpenbert AS9100 7.5.3 - Manual Document Control AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
S Software design document NMPA guidance and consultant China Medical Device Regulations 4
qualprod Is it worth to document all the processes? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S Help in document control procedure Document Control Systems, Procedures, Forms and Templates 14

Similar threads

Top Bottom