Micrus Endovascular received approval for the devices from the Pharmaceuticals and Medical Devices Agency
(PMDA), an independent administrative agency, on March 1.
As a result the Medical Devices Agency
issued a hazard notice and in December the DOH said reusable instruments could again be used.
found that device regulation is swathed in secrecy, with the Medical Devices Agency
(MDA) refusing to give details about action it takes against specific companies.
But an investigation by the Medical Devices Agency
found 'inadequacies' in the makers' safety assessments.
The Department of Health's Medical Devices Agency
in London is sending a team to the plant, and has been in contact with the US agency.
The implants containing soya oil were withdrawn in March last year and now the government's Medical Devices Agency
is advising women that they could cause cancer.
The Medical Devices Agency
and the Health and Safety Executive were asked to investigate the lamps to see if there was a national problem.
Mycovia has reached agreement on pivotal study designs with the US Food and Drug Administration, European Medicines Agency and Japan's Pharmaceuticals and Medical Devices Agency
Merck announced today that Keytruda, Merck's anti-PD-1 therapy, has simultaneously received five new approvals from the Japan Pharmaceuticals and Medical Devices Agency
, or PMDA, including three expanded uses in advanced non-small lung cancer, or NSCLC, one in melanoma, as well as a new indication in advanced microsatellite instability-high, or MSI-H, tumors.
Starpharma Holdings Limited (Starpharma) (ASX:SPL) (OTCQX:SPHRY) announced on Tuesday that its VivaGel condom has received final regulatory approval in Japan, following the completion of the Japanese Pharmaceuticals and Medical Devices Agency
(PMDA) review of the product's medical device classification and associated data.
The 30-day review period of clinical trial notification of the regenerative cell therapy SB623 for traumatic brain injury in Japan, submitted to the Japanese Pharmaceuticals and Medical Devices Agency
(PMDA) on March 7 lapsed without any expressions of concern.