PRECAUTIONS in package inserts include information such as Warning, Contraindications, Important Precautions, and Clinically Significant Adverse Reactions. When a new risk is identified, the PMDA thoroughly investigates the risk and discusses the necessity of revision of PRECAUTIONS with expert advisors so that the PMDA can recommend an additional safety measure to the MHLW. Following the investigation results by the PMDA, the MHLW issues a notice to revise PRECAUTIONS. The marketing authorization holders consequently revise PRECAUTIONS in accordance with the notice.
| Date | Device name | Revisions of PRECAUTIONS (by the MHLW) Summary of investigation results by the PMDA) (if applicable) |
|---|---|---|
| December, 24, 2021 | Power morcellators | Revision of PRECAUTIONS [119 KB] |
| November 22, 2019 | Artificial ventilator, etc. expected to be used at home | Revision of PRECAUTIONS [147 KB] |
| October 10, 2019 | Drug-eluting coronary stent Drug-coated balloon dilatation catheter for coronary angioplasty |
Revision of PRECAUTIONS [172 KB] |
| June 7, 2019 | Gel-filled breast implant | Revision of PRECAUTIONS [58.7 KB] |
| August 8, 2018 | Ultrasonic surgical aspirator devices | Revision of PRECAUTIONS [51.3 KB] Summary of investigation results [768 KB] |
| November 2, 2017 | Medical devices containing chlorhexidine gluconate or chlorhexidine hydrochloride | Revision of PRECAUTIONS [140 KB] |
| July 25, 2016 | Power morcellators | Revision of PRECAUTIONS [117 KB] |
| March 31, 2016 | Metal-on-metal artificial hip prosthesis | Revision of PRECAUTIONS [101 KB] |
| July 29, 2015 | Electrosurgical devices and intraocular lens | Revisions of PRECAUTIONS [34.3 KB] Summary of investigation results [159 KB] |
| July 21, 2015 | Medical devices and in vitro diagnostics for blood glucose measurements using enzymatic electrodes | Revision of PRECAUTIONS [29.2 KB] Summary of investigation results [135 KB] |
| December 9, 2014 | Small-intestinal capsule endoscope | Revision of PRECAUTIONS [34.0 KB] |
| July 28, 2014 | Drug-eluting coronary stent or drug-coated balloon dilatation catheter for coronary angioplasty | Revision of PRECAUTIONS [103 KB] |