Regulatory application service
In order to sell medical devices in Japan, companies must comply with Japanese regulations.
| Criteria for medical devices | Examination | Grant approval |
|---|---|---|
| Specially controlled medical device Controlled medical device | Application to PMDA*1 | Approved by the MHLW*2 |
| Designated specially controlled medical device Designated controlled medical device | Application to RCB*3 | Certificate by RCB |
| General medical device | Notification to PMDA | － |
Medical devices must receive approval (certification) for each item by Japanese regulatory authorities, including the RCB, the Pharmaceuticals and Medical Devices Agency (PMDA), and the Ministry of Health, Labour and Welfare (MHLW).
Please contact us for draft and support of the following Regulatory application.
- Registration of Foreign Medical Device Manufacturer
- 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 - 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 - Consultation services (various types of consultation support for PMDA)
①Package inserts consultation
②Face-to-face advice
Please contact us for more information.