Medical Device Regulations

Medical Device Regulations

A Complete Guide

Deep, Aakash

Elsevier Science & Technology

01/2022

186

Mole

Inglês

9780323911269

15 a 20 dias

410

Descrição não disponível.
1. Introduction of medical devices
2. Ethics of clinical trials of medical devices
3. Regulations for medical devices in the United States
4. Regulations of medical devices in Europe
5. Regulations of medical devices in ASEAN countries
6. Regulations of medical devices in Japan and China
7. Regulations of medical devices in Canada
8. Regulations of medical devices in India
9. Regulations of medical devices in Australia
10. Regulations of medical devices in GCC countries
11. Regulations of medical devices in Sri Lanka
12. Regulations of medical devices in Russia
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?ASEAN; Approval process; Australian regulatory authority; CDDA; Central Drugs Standard Control Organization; China; Classification; Classifications; Clinical investigation; Clinical investigational plan; Clinical investigations; Common Submission Dossier Template; Conformity Europeans; Conformity assessment; Drugs Controller General of India; EU MDR Framework; European Medicines Agency; Food and Drug Act; Food and Drug Authority; Gulf Cooperation Council; ISO 13485; ISO 14155; ISO 14971; Investigational device exemption; Japan; Labeling requirement; Labeling requirements; MDEC; MHLW; Medical Product Life Cycle; Medical devices; Medical devices regulation in United States; Myanmar; NAFTA; NMRA; National Medicines Regulatory Authority; North American Free Trade Agreement; PMDA; Philippines; Premarket approval; Registration procedures; Registration process; Regulation; Safety managements; Singapore; Therapeutic Good Act