Mr Loughton said: "The
Medical Devices Agency concluded it was isolated to the flanges manufactured for here only and decided it was just a local problem.
Food and Drug Administration (FDA) and clearance in Japan from the Pharmaceutical and
Medical Devices Agency, PMDA.
AstraZeneca (LON: AZN) and MSD (NYSE: MRK), known as Merck & Co in the US and Canada, have submitted a new drug application (NDA) to Japan's Pharmaceuticals and
Medical Devices Agency (PMDA) for Lynparza (olaparib) tablets in resectable or recurrent BRCA-mutated breast cancer, the Anglo-Swedish multinational pharmaceutical company disclosed on Monday.
In Japan, osimertinib was granted Priority Review by the Pharmaceuticals and
Medical Devices Agency (PMDA).
has initiated dialog with the Japanese regulatory authority, the Pharmaceuticals and
Medical Devices Agency (PMDA); and
It is important for foreign medical device companies to be aware of what is required by the Ministry of Health, Labor and Welfare (MHLW) and by the Pharmaceuticals and
Medical Devices Agency (PMDA) to sell in this market.
based spinal device firm was recently given approval by Japan's Pharmaceuticals and
Medical Devices Agency to sell its MESA spinal screw system there.
Based on the results of clinical trials conducted in the Japan, EU and the US, the company plans to launch a global phase III clinical trial in August, with consent from both FDA and the Pharmaceuticals and
Medical Devices Agency.
All women who had their implants removed after the Government's
Medical Devices Agency made its recommendation in June will receive compensation, regardless of whether they have suffered any health problems or not.
The implants containing soya oil were withdrawn in March last year and now the government's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.
Gambro and the
Medical Devices Agency issued a warning to all health authorities, advising them to change the date on the equipment or manually disinfect the machines.
The
Medical Devices Agency and the Health and Safety Executive were called in and three operating theatres taken out of use while checks were carried out.
