Japan's MHLW #169 vs ISO 13485:2003

R

RG Ohidy

I have been looking for a cross reference table between Japans MHLW #169 and ISO 13485:2003.

Any suggestions on where to look for such a table, or if someone has one they would like to share?

Thanks,

Rich
 

Al Rosen

Leader
Super Moderator
R

RG Ohidy

Ok, thanks, but I already have the 169, was just wondering if anyone had put a matrix together.
I'll see what I can do, and post one.
 

Al Rosen

Leader
Super Moderator
RG Ohidy said:
Ok, thanks, but I already have the 169, was just wondering if anyone had put a matrix together.
I'll see what I can do, and post one.
Thanks!!
 
R

RG Ohidy

Here is a table I created. The table can be modified to include other standards/requirments, as well as listing procedures that apply to each.

Rich
 

Attachments

  • MHLW #169 vs ISO 13485 2003.xls
    32 KB · Views: 1,298
U

username

Hi
That was a great work!
Do you happen to have an updated version of ISO 13485:2003 Vs. MHLW (Ministerial Ordinances on GQP & GMP) 2005?
Thanks
S
 
M

Mary Flynn

Thank you so much for this matrix, you have saved me a lot of time.
 
C

CBAL08

Is the Matrix still valid after the changes as well which occured in November 2014?
 
Thread starter Similar threads Forum Replies Date
K MHLW MO169 2021 Japan Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostics Japan Medical Device Regulations 4
P Japan MHLW Ordinance No 94. (QMS structure Regulation) Japan Medical Device Regulations 1
N Need guidance on registration of medical device with MHLW (Japan) Japan Medical Device Regulations 1
N Over labelling in Japan Japan Medical Device Regulations 1
H Need guidance on importation of Custom-made devices into Japan Japan Medical Device Regulations 1
B Document retention Policy for Japan's PMDA Japan Medical Device Regulations 1
D Japan adverse event form Japan Medical Device Regulations 1
B Registration of a CE-marked medical device in Japan -Will they accept conformity with GSPRs? Japan Medical Device Regulations 0
J Japan registration need manual without temperature reading Japan Medical Device Regulations 0
JoCam Electrical Testing for Japan, PSE or CB Scheme Other Medical Device Regulations World-Wide 2
A Medical Device Vigilance decision tree for Japan for class 2 devices. Japan Medical Device Regulations 1
V OEM / PLM Japan Japan Medical Device Regulations 1
M Brazil and Japan - Essential requirements Other Medical Device Regulations World-Wide 3
A Japan's Requirements for Reporting Medical Device Adverse Events Other Medical Device Regulations World-Wide 3
Ajit Basrur Refurbisher of medical devices in Japan Japan Medical Device Regulations 0
F Vietnamese Post-Market Surveillance Requirements for a medical device in Japan Other Medical Device Regulations World-Wide 0
F Looking for a Japan MAH recommendation that is not too expensive Japan Medical Device Regulations 6
supadrai Informational Japan Minor Change Notification Application Form - Found it? Japan Medical Device Regulations 0
J Medical Devices in Japan - Conformity of QMS to ISO 13485 Japan Medical Device Regulations 1
S Scope change in Japan - Class I disposable medical devices Japan Medical Device Regulations 0
Q JIS T 1115 Comparison (Japan Medical Device Standard) Japan Medical Device Regulations 0
J Japan's Definition of Should and Shall Japan Medical Device Regulations 1
shimonv Off-Label Use of a Medical Device in Japan Other Medical Device Regulations World-Wide 2
J MDSAP Regulatory Requirements other than in Japan, Brazil, Australia, Canada, US ISO 13485:2016 - Medical Device Quality Management Systems 3
J Japan AE (Adverse Event) Reporting Requirements Japan Medical Device Regulations 5
C Does Japan accept the Bracketing Approach for Process Validation Japan Medical Device Regulations 1
B Where can I find an English version of Japan's PMD Act? Other ISO and International Standards and European Regulations 2
P Content of an IVD Technical Dossier to Register a Device to Japan Japan Medical Device Regulations 0
E IVD Classification in Japan based on the Japanese Pharmaceutical Affairs Law Japan Medical Device Regulations 2
A Japan Medical Device Labeling Requirements Japan Medical Device Regulations 5
F If Japan Can?Why Can?t We? (Claire Crawford-Mason) Philosophy, Gurus, Innovation and Evolution 3
R Selling of Medical Power Supply in Australia/New Zealand and Japan Other Medical Device Regulations World-Wide 5
C Japan Regulations - Resistance of Medical Gloves to Permeation Japan Medical Device Regulations 1
T Testing bluetooth medical devices against Japan Radio Law requirements Japan Medical Device Regulations 2
B Japan Medical Device Recall Requirements Japan Medical Device Regulations 4
J Requirements for Importing Research Use Only Medical Devices into Japan Japan Medical Device Regulations 1
U Language requirements - Software interface - Japan and South Korea Japan Medical Device Regulations 4
E Japan - Medical Device Classification for Mass Spectrometry Japan Medical Device Regulations 2
B Japan PAL QMS Audit Experience Other Medical Device and Orthopedic Related Topics 8
C Revision of Japan's Pharmaceutical Affairs Law (PAL) in 2014 Japan Medical Device Regulations 10
J EU CE Mark Validity in Non EU countries - Brazil. Taiwan, China, Japan, Mexico EU Medical Device Regulations 1
P Japan Requlatory Requirement for Nerve Scaffold using Human Tissue Japan Medical Device Regulations 2
D Japan Rules for Marketing Authorization Holders Japan Medical Device Regulations 1
P Sampling QC Requirements for Medical Electrical Device Export to Japan Japan Medical Device Regulations 1
R Reporting Times & Requirements for when an Adverse Event has occurred (Japan) Japan Medical Device Regulations 3
N Barcode Registration Requirements for Japan and GUDID Japan Medical Device Regulations 2
S QMS to demonstrate Compliance to Canada, Europe and Japan Other Medical Device Regulations World-Wide 7
R Equivalent CE for export to Japan - Stand exibition with LED lights CE Marking (Conformité Européene) / CB Scheme 3
F Biocompatibility study conducted in the GLP lab outside Japan Japan Medical Device Regulations 2
G More than one Marketing Authorization Holder (MAH) in Japan Japan Medical Device Regulations 2

Similar threads

Top Bottom