Titlebook: In vitro Diagnostic Medical Devices: Law and Practice in Five EU Member States; Bernhard Maassen,Robin Whaite,Gonzalo Ulloa,Bernha Book 19

西瓜

https://doi.org/10.1007/978-94-015-8319-0English; European Union (EU); Germany

閃光東本

978-90-481-4439-6Springer Science+Business Media B.V. 1994

Obedient

periodontitis

幼稚

Law and Practice in Italy,In Italy, IVDMDs are expressly provided for in Presidential Decree no. 128 of 13 March 1986, relating to the manufacturing and marketing of medico-surgical devices (“DPR 128/86”).

Foment

Law and Practice in Spain,The Spanish Health Act (“Ley General de Sanidad, 1986”) in Article 40 gives the Central Administration the power to regulate, authorize and approve health products. Article 110 provides that the Ministry of Health controls the safety of health and medical technology.

amplitude

Summary of Findings of the National Reports,Regulations on IVDMDs in the five nations studied (France, Germany, Italy, Spain and the United Kingdom) vary considerably from country to country in scope and content.

饑荒

Law and Practice in the United Kingdom,ts, are regulated by non-governmental administrative codes of practice and commonly adhered to standards. The exceptional area of law relating directly to IVDMDs is a Statutory Instrument (secondary legislation) regulating the sale and supply of HIV testing kits to the public. This is discussed in section 2 of this report.

預(yù)感

Flatus