Japan Requlatory Requirement for Nerve Scaffold using Human Tissue

P

pseudoazurin

Involved In Discussions
Hi there,

Anyone got any idea about Japan requlatory requirement for for nerve scaffold from decellularized extracellular matrix from human peripheral nerve for the repair and protect nerves.
 
Ronen E

Ronen E

Problem Solver
Moderator
pseudoazurin said:
Hi there,

Anyone got any idea about Japan requlatory requirement for for nerve scaffold from decellularized extracellular matrix from human peripheral nerve for the repair and protect nerves.
Click to expand...

I don't - it sounds like something very specialized. My experience re. Japan is that you need someone local, but on the other hand you might have communication issues if they're too local... Maybe try to ask these guys (absolutely no affiliation here):

http://www.emergogroup.com/services/japan

All the best,
Ronen.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
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
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
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
P Japan MHLW Ordinance No 94. (QMS structure Regulation) 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
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
N Need guidance on registration of medical device with MHLW (Japan) Japan Medical Device Regulations 1
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
A Japan Medical Devices Vigilance Regulations or Guidelines Japan Medical Device Regulations 4

Similar threads

Top Bottom