Table of Contents
Medical Device Registration in Japan
Classification | Example | Medical Device Registration in Japan Regulation | Document submit to |
Class I General medical devices | X-ray film, surgical knife, most of IVD device | Notification (Self-declaration) | PMDA |
Class II Controlled medical devices | MRI, Electro-Endoscope, Dental Alloy | Certification (Device with certification criteria) | RCB |
Approval (Device without certification criteria)
Seldom happens | PMDA | ||
Class III Highly controlled medical devices | Synthetic bone, balloon catheter for cardiac blood vessels, ventilator | Certification (Device with certification criteria) | RCB |
Approval | PMDA | ||
Class IV Highly controlled medical devices | Pacemaker, stent, artificial cardiac valve | Approval | PMDA |
Class I
Review of related documents & Data gap analysis Investigation of other similar products Determine the classification of your device according to the Japan Pharmaceutical Affairs Law and JMDN code Lead time 2 mths
|
Class I General Medical devices |
Submit Pre-market Notification to PMDA**
|
Launch
|
**PMDA: Pharmaceuticals and Medical devices Agency
Class II
Review of related documents & Data gap analysis Investigation of other similar certificated products Determine the classification of your device according to the Japan Pharmaceutical Affairs Law and JMDN code Evaluate the necessity of clinical trials in Japan 3 months, 12 months in case of clinical trial | |||
Class II Specified controlled Medical devices*
| Class II Controlled Medical devices
| ||
Meet the certification standards
| Not meet the certification standards
| Submit Pre-market Approval application to PMDA & Examination 10 months
| Conduct a clinical trial in Japan 12～24 months
|
Submit Pre-market certification to RCB***& Examination 4 months
| Submit Pre-market Approval application to PMDA & Examination 10 months
| Reimbursement activity to MHLW 2 months
| Submit Pre-market Approval application to PMDA & Examination 12 months
|
Reimbursement activity to MHLW 2 months
| Reimbursement activity to MHLW 2 months
| Launch
| Reimbursement activity to MHLW 8 months |
Launch
| Launch
| Launch
| |
*Specified Controlled Devices: Devices which meet the certification standards based on ISO.
***RCB: Registered Certification Body
MHLW:Ministry of Health, Labour and Welfare
Class III and IV
Review of related documents & Data gap anaysis Investigation of other similar approved products Determine the classification of your device according to the Japan Pharmaceutical Affairs Law and JMDN code Evaluate the necessity of clinical trials in Japan
4 months, 12 months in case of clinical trial
| ||||
Class III Highly controlled Medical devices
| Class IV Highly controlled Medical devices
| |||
Meet the Approval standards
| Not meet the Approval standards
| Conduct a clinical trial in Japan 12～24 months
| Submit Pre-market Approval application to PMDA & Examination 10 months
| Conduct a clinical trial in Japan 12～24 months
|
Submit Pre-market Approval application to PMDA & Examination 9 months
| Submit Pre-market Approval application to PMDA & Examination 10 months
| Submit Pre-market Approval application to PMDA & Examination 12 months
| Reimbursement activity to MHLW 2 or 8 months
| Submit Pre-market Approval application to PMDA & Examination 12 months
|
Reimbursement activity to MHLW 2 months
| Reimbursement activity to MHLW 2 or 8 months
| Reimbursement activity to MHLW 8 months
| Launch
| Reimbursement activity to MHLW 8 months
|
Launch
| Launch
| Launch PMS 12～36 months
| Launch PMS 12～36 months
| |
