Regulatory application service

In order to manufacturing and sale medical devices in Japan, applications and notifications are required for each product according to the product name of the medical device in accordance with the Pharmaceuticals and medical devices act (PMD Act).

Criteria for medical devicesExaminationGrant approval
Specially controlled medical device  
Controlled medical device
Application to PMDA*1Approved by the MHLW*2
Designated specially controlled medical device   
Designated controlled medical device
Application to RCB*3Certificate by RCB
General medical deviceNotification to PMDA

       

Medical devices must receive approval(certification) for each such item by Japanese regulatory authorities, including the RCB, the Pharmaceuticals and Medical Devices Agency (PMDA) and Ministry of Health, Labour and Welfare (MHLW).
Please contact us for draft and support of the following Regulatory application.

  1. Registration of Foreign Medical Device Manufacturer
  2. Application for manufacturing and sale of Medical Devices, etc.  
    ①Marketing Notification of Medical Device  
    ②Application for approval of manufacturing and sale of designated (specially) controlled medical device  
    ③Application for sale approval of (specially) controlled medical device
  3. Procedures for changes in approved and other matters for medical devices  
    ①Judging the validity of changes  
    ②Application for partial changes to approved (certified) items  
    ③Notification of minor changes in approved (certified) matters
  4. Consultation services (various types of consultation support for PMDA)  
    ①Package inserts consultation  
    ②Face-to-face advice
  1. PMDA:Pharmaceuticals and Medical Devices Agency ↩︎
  2. MHLW:Japan’s Ministry of Health, Labour and Welfare ↩︎
  3. RCB:Registered Certification Bodies ↩︎

Please contact us for more information.