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Revisions of PRECAUTIONS

PRECAUTIONS in package inserts include information such as Warning, Contraindications, Important Precautions, and Clinically Significant Adverse Reactions. When a new risk is identified, the Pharmaceuticals and Medical Devices Agency (PMDA) thoroughly investigates the risk and discusses a necessity of revision of PRECAUSIONS with expert advisors so that the PMDA can recommend an additional safety measure to the Ministry of Health, Labour and Welfare (MHLW). Following the investigation results from the PMDA, the MHLW issues a notice to revise PRECAUSIONS. Marketing authorization holders consequently revise PRECAUTIONS according to the notice.
 

Posted date Device name Detailed information on revisions of PRECAUTIONS (from MHLW) Summary of investigation results (from PMDA)
July 26, 2016

July 25, 2016
(Originally Posted in Japanese)
Power Morcellators Precautions in the Package Insert of Power Morcellators N/A
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
N/A
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
PDF
September 1, 2015

July 21, 2015
(Originally Posted in Japanese)
Medical devices and in vitro diagnostics for blood glucose measurements using enzymatic electrodes
PDF
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 -
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 -

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Revisions of PRECAUTIONS
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