| Regulatory Authority | The Pharmaceuticals and Medical Devices Agency (PMDA) |
|---|---|
| Regulatory Authority Website Link | Click Here |
| Device Classification | I, II, III, IV |
| Medical Device Regulations | Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Same Regulations for IVD) | Click Here |
| IVD Classification | I,II,III |
| In Vitro Diagnostics Regulations | https://www.japaneselawtranslation.go.jp/en/laws/view/3213/en#je_ch0 |
| Registration Process | Regulations and Approval/Certification of Medical Devices | Click Here |
| Registration Timeline | Class I: 1 monthClass II: 3 monthsClass III and IV: 6 months to 2 years |
| Conformity Assessment Route |
Class I devices: Notification to the PMDA |
| Technical Documentation Format |
Summary Technical Documentation (STED): Harmonizing a Predictable Regulatory Submission | Click Here |
| Requirement of Authorized Representative | YES |
| Language Requirement | Labels must be in Japanese Language |
| Clinical Trials Information |
A "clinical trial" involves conducting clinical trials to determine the effects and side effects of using drugs, machinery and equipment, processed cells, etc., and collecting data to be included in applications for approval of pharmaceuticals, medical devices, regenerative medicine, and other products. | Click Here |
| Certificate of Free Sale |
Issuance of Certificates for Medical Devices for Export | Click Here |
| Recalls |
Recall Information | Click Here |
| Additional Information | There are two regulatory authorities responsible for regulation of medical devices in Japan: the Ministry of Health, Labour and Welfare (MHLW) and the PMDA. The MHLW is responsible for the administrative actions. On the other hand, the PMDA undertakes product review and post-market safety measures. |