西瓜 发表于 2025-3-23 10:45:48

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

闪光东本 发表于 2025-3-23 16:22:47

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

Obedient 发表于 2025-3-23 18:01:15

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periodontitis 发表于 2025-3-24 00:12:52

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幼稚 发表于 2025-3-24 04:11:46

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 发表于 2025-3-24 07:51:04

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 发表于 2025-3-24 11:12:17

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.

饥荒 发表于 2025-3-24 18:22:02

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.

预感 发表于 2025-3-24 20:19:58

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Flatus 发表于 2025-3-25 01:13:11

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