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
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
has initiated dialog with the Japanese regulatory authority, the Pharmaceuticals and Medical Devices Agency
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The implants containing soya oil were withdrawn in March last year and now the government's Medical Devices Agency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.