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.
| Posted date | Device name | Detailed information on revisions of PRECAUTIONS (from MHLW) | Summary of investigation results (from PMDA) |
|---|---|---|---|
| December, 24, 2021 | Power Morcellators | Revision of Precautions in the Package Insert of Power Morcellators | not applicable |
| November 22, 2019 | Artificial ventilator, etc. expected to be used at home | Revision of Precautions for Artificial Ventilator, etc. Expected to be Used at Home | not applicable |
| October 10, 2019 | Drug-eluting coronary stent Drug-coated balloon dilatation catheter for coronary angioplasty |
Revision of Precautions to the Package Inserts of Drug-eluting Coronary Stent or Drug-coated Balloon Dilatation Catheter for Coronary Angioplasty | not applicable |
| June 7, 2019 | Gel-filled Breast Implant | Revision of Precautions to the Package Insert of Gel-filled Breast Implant | not applicable |
| November 13, 2018 August 8, 2018 (Originally Posted in Japanese) |
Ultrasonic Surgical Aspirator Devices | Revision of Precautions to the Package Inserts of Ultrasonic Surgical Aspirator Devices | Revision of Precautions to the Package Inserts of Ultrasonic Surgical Aspirator Devices |
| November 30, 2017 November 2, 2017 (Originally Posted in Japanese) |
Medical Devices Containing Chlorhexidine Gluconate or Chlorhexidine Hydrochloride | Revision of Precautions in the Package Inserts of Medical Devices Containing Chlorhexidine Gluconate or Chlorhexidine Hydrochloride | not applicable |
| July 26, 2016 July 25, 2016 (Originally Posted in Japanese) |
Power Morcellators | Precautions in the Package Insert of Power Morcellators | not applicable |
| April 11, 2016 March 31, 2016 (Originally Posted in Japanese) |
Metal-on-Metal Artificial Hip Prosthesis | Revision of the Precautions in the Package Insert of Medical Devices that Constitute Metal-on-Metal Artificial Hip Prosthesis | not applicable |
| September 7, 2015 July 29, 2015 (Originally Posted in Japanese) |
Electrosurgical devices and Intraocular lens | Partial modifications to instructions on revisions of the precautions associated with amendments to the notes on compilation for medical device package inserts | |
| September 1, 2015 July 21, 2015 (Originally Posted in Japanese) |
Medical devices and in vitro diagnostics for blood glucose measurements using enzymatic electrodes | Revision of the Precautions in the package insert of Medical devices and in vitro diagnostics for blood glucose measurements using enzymatic electrodes | |
| June 19, 2015 December 9, 2014 (Originally Posted in Japanese) |
Small-intestinal capsule endoscope | Revision of the Precautions in the package insert of the Small-intestinal capsule endoscope | not applicable |
| July 15, 2015 July 28, 2014 (Originally Posted in Japanese) |
Drug-eluting coronary stent or Drug-coated balloon dilatation catheter for coronary angioplasty | Revision of the Precautions in the package insert of Drug-eluting coronary stent or Drug-coated balloon dilatation catheter for coronary angioplasty | not applicable |