The Pharmaceuticals and Medical Devices Agency (PMDA) within the Japanese Ministry of Health, Labour and Welfare (MHLW) is responsible for the registration of medical devices in Japan. A manufacturer must appoint a Market  Authorization Holder (MAH), who is responsible for the release of the product to the market.
 
Medical device classification is divided into General Medical devices (Class I), Controlled Medical Devices (Class II) and Specially Controlled Medical Devices (Class III and IV). IVDs are classified as medical devices.
 
IVDs are not classified under class IV. IVD reagents belong to class II. For manufacturers of medical devices, certificates of Japanese Good Manufacturing Practice (GMP) and Good Vigilance Practice (GVP) are required.  Our country specific (*) regulatory services in Japan include:
 
Medical Device specific regulation strategy reports, Medical Device Registration with PMDA, Japan Health Technical documents Preparation, Japan Market Authorized Holder and local Representative (MAH), Japan GMP compliance and Arazy Group’s unique line of GlobaR - Global Regulatory Hub™ products.
 
GlobaR Dossier™
GlobaR - One World Process™
GlobaR Submission Center ™
Universal Authorized Representative™
 
Please fill the following form, submit your inquiry or discuss it with one of our online specialists. Let's get your products registered in Japan!

(*) Japanese Regulatory Affairs services are part of the diverse professional consulting services provided by Arazy Group and can be found thorough this web site and inquired on through our form or online chat services.