Medical Devices Agency

There is much concern for the safety of personnel handling articles contaminated with pathogenic viruses such as hepatitis B virus (HB V) and human immunodeficiency vims (HIV) which causes acquired immune deficiency syndrome (AIDS). Some agents have been recommended for disinfection of HBV and HIV depending on the circumstances and level of contamination these are hsted in Table 10.4. Disinfectants must be able to treat rapidly and reliably accidental spills of blood, body fluids or secretions from HIV infected patients. Such spills may contain levels of HIV as high as lO" infectious units/ml. Recent evidence Irom the Medical Devices Agency evaluation of disinfectants against HIV indicated that few chemicals could destroy the vims in a... 

Sterilization, Disinfection and Cleaning of Medical Equipment Microbiology Advisory Committee (1993) Guidance on Decontamination fixMnttie Microbiology Advisory Committee to Department of Health Medical Devices Directorate. Part 1 Principles. London HMSO. van Bueren J., Salman H. Cookson B.D. (1995) The Efficacy of Thirteen Chemical Disinfectants against Human Immunodeficiency Virus (HIV). Medical Devices Agency Evaluation Report. 

The Pharmaceutical and Medical Device Agency (PMDA) of the MHLW is responsible for drug approval in Japan. 

Drug approval processes go through IND and NDA procedures in Japan. The MHLW of Japan has set up the Pharmaceutical and Medical Device Agency (PMDA), which provides technical consultation services for clinical trials. There are four types of consultations before IND, at the end of Phase II studies, before NDA, and consultation on individual protocols. 

PMDA Pharmaceutical and Medical Devices Agency (Japan)... 

On the 12 September 2002, the Health Minister, Lord Philip Hunt announced that the MCA and the Medical Devices Agency (MDA) would merge with effect from 1 April 2003. The merged agency would be known as the Medicines and Healthcare products Regulatory Agency (MHRA). 

Different national agencies have different practices on what action they may take when faced with dangerous products. The UK Medical Devices Agency, for example, operates a practice of issuing a sequence of three advisory notices to UK health services, for which the criteria for the various safety warning categories are as follows. ... 

Guidance Notes for Manufacturers or Clinical Investigations to be carried out in the UK, Medical Devices Agency, September 1996. 

The Medical Devices Vigilance System European Commission Guidelines, Medical Devices Agency, undated. 

Medical Devices Agency, Guidance on the Recall of Medical Devices, 2000. 

Responsibility for regulatory review has been passed to an Incorporated Administrative Agency, the Pharmaceutical and Medical Devices Agency (PMDA). PMDA also intensively checks applications for GCP compliance and reliability compliance. Another important role of PMDA includes an advice to sponsors on clinical trials and on which result can be submitted at the time of a new drug application. 

U.K. Medical Device Agency (1994), Standards, Bulletin No. 13, November. 

In 1999, the UK Medical Devices Agency announced the voluntary withdrawal of a breast implant that contained soybean oil. The decision was taken because not enough was known at that time about the long-term safety and the rate of breakdown of the soybean oil in the filling and its possible effects on the body. "" ... 

The PFSB, the Health Policy Bureau, with the assistance of the PAFSC, and the Pharmaceuticals and Medical Devices Agency (PMDA or Kiko in Japanese) represent the managing authorities of Japanese pharmaceutical administration, in charge of reviewing drug application for approval, reexamination or re evaluation. 

UK Medical Devices Agency (MDA) Medical device regulations and guidance notes for industry on European Directives for medical devices Web site httpWwww. medical-devices.gov.uk/... 

The amount of detail for approval of the device increases from Class I to Class III. In the UK submission of data and subsequent approval is through the Medical Device Agency (MDA). Devices have to be independently assessed by MDA Notified Bodies, which on approval can issue the authorised CE mark this allows unrestrained distribution across Europe. 

MDA SN9617 (1996) Zirconia Ceramic Heads for Modular Total Hip Femoral Components Advice to Users on Resterilization. Medical Device Agency Adverse Incident Center, Department of Health, London, Safety Notice, June 1996. 

This study was supported in part by the Program for the Promotion of Fundamental Studies in Health Sciences (MPJ-6) of the Pharmaceuticals and Medical Devices Agency (PMDA). The authors thank Yakult Honshu Co. for generously donating SN-38 and SN-38 glucuronide, and Ms. Clue Knudsenfor her secretarial assistance. 

The Japanese regulatory process was revised in 2004, creating the Pharmaceutical and Medical Devices Agency (PMDA), and provisions relating to medical devices came into effect on April 1, 2005 [16], In Japan two submissions may be required a KIT Drug J-NDA submission and a separate Medical Device Certification the latter of these has to be filed with PMDA. It should be noted that the review timelines for KIT Drug and Medical Device Certification submissions... 

Pharmaceutical and Medical Devices Agency (PMDA) Japan website, http //www.pmda.go.jp/ english/index.html... 

---