Each issue includes summaries in German, French and Spanish

In the current issue...

Interview: Sinisa Tomic, Director of the Croatian Agency for Medicinal Products and Medical Devices talks to the JMDR
MDD revisions: David Jefferys discusses the future revision of the European Medical Devices Directives
Clinical trials: Haroon Atchia questions the ethics of offshoring clinical trials
FDA PMA disapprovals: Ralph Jugo performs an analysis of the reasons and merits for FDA PMA disapproval
Dispute resolution: Sharon Frank asks whether a centralised dispute resolution procedure is needed for borderline and classification matters
Reimbursement: Barb Peterson looks at medical device reimbursement in the USA
Regulatory updates: Australia, Brazil, Canada, China, Europe, Germany, Hong Kong, India, International, Italy, Korea, Paraguay, Saudi Arabia, Singapore, South Africa, Switzerland, Thailand, Turkey, the UK, the USA, and Vietnam plus standards and regulatory personnel on the move
Country overview: the medical device regulatory requirements in Brazil
Elemental Essentials: investigational device exemptions (IDEs) in the USA
Book review: 'Pharmaceutical and Medical Device Validation by Experimental Design'
NB-MED: List of NB-MED Recommendations on Council Directives 90/385/EEC, 93/42/EEC and 98/79/EC