- List of Approved Products
- Review Reports: Drugs
- Review Reports: Medical Devices
- Package Inserts (in Japanese)
- Good Review Practice
- Projects Across Multi-Offices in PMDA
- Record of Consultations on Pharmacogenomics / Biomarkers
- Task Force for Advanced Review and Consultation with Electronic Data
- PMDA Risk Communications
- The Yellow Letter / Blue Letter
- Safety Information announced by MHLW
- MHLW Pharmaceuticals and Medical Devices Safety Information
- PMDA Medical Safety Information
- PMDA Request for Proper Use of Drugs
- Risk Management Plan (RMP)
- Other Information (in Japanese)
- MIHARI project
- Regulations (in Japanese)
The following English translations of review reports are intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese originals and the translations, the former shall prevail. PMDA shall not be responsible for any consequence resulting from use of the English versions.
The review reports were selected for translation among those of new medical devices that recently received marketing approval, in consideration of relevant factors including the novelty and priority.
- English translations of the review reports are under preparation. They will be uploaded sequentially.
|Brand Name||Generic Name||Approved In||PDF
|DuraHeart Left Ventricular Assist System||implantable ventricular assist device||Dec. 2010|
|Endeavor Coronary Stent System||coronary stent||Mar. 2009|
|GORE TAG Thoracic Aortic Stent Graft System||aortic stent grafts||Mar. 2008|
|Implantable Ventricular Assist System EVAHEART||implantable ventricular assist device||Dec. 2010|| 1.
|JACE||other surgical/orthopedic materials (autologous cultured epidermis)||Oct. 2007|