Any experts experience in Japan product registration???
May know which website and where can I know where to search regards product registration in Japan market? Looking into the rules and regulations in regards about that.
Any experts experience in Japan product registration???
May know which website and where can I know where to search regards product registration in Japan market? Looking into the rules and regulations in regards about that.
I'm dealing with Japanese regulations for already 3 years - including about 5 product approvals (sterile and electromechanical) and management of QMS according to JPAL requirements. For me this book was very helpful:
The Regulatory System and Requirements in Japan for Medical Devices by TUV SUD Japan. This book provides an explanation of Shonin application as well as detailed product related requirements. In additon, you can find there the overview of the PAL requiremens and info regarding the licences and registration. Further info is here: http://www.tuv-sud.jp/english/infoservice/pharmaceutical_affairs_law.html
In addition to my previous post refer the Synergus link How to Manage Regulatory Affairs for a Medical Device in Japan - A guideline focusing on European manufacturers of medical devices. You can find the details including Japanese regulatory framework for medical devices, Steps to register a medical device in Japan, product registration process, managing product modification, clinical trial in Japan, post marketing surveillance and adverse event reporting and medical device reimbursement and so on.
Hello - I looked through all the information - thank you - and the point of reference in English anyway, is often from the foreign manufacturing point of view. My colleagues in Japan are all asleep now - can anyone tell me if a Japan manufacturer has to use a RCB (3rd party) for Class II submissions or if they can apply directly to PMDA?
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