02664oam 2200577I 450 991078611250332120230803025725.00-429-07135-3981-4411-22-110.1201/b14081 (CKB)2670000000343265(EBL)1165926(OCoLC)837602091(SSID)ssj0000905630(PQKBManifestationID)11563941(PQKBTitleCode)TC0000905630(PQKBWorkID)10927400(PQKB)10744803(MiAaPQ)EBC1165926(Au-PeEL)EBL1165926(CaPaEBR)ebr10681933(CaONFJC)MIL501536(EXLCZ)99267000000034326520180331d2013 uy 0engur|n|---|||||txtccrHandbook of medical device regulatory affairs in Asia /Jack Wong, Raymond K.Y. TongBoca Raton, Fla. :CRC Press,2013.1 online resource (610 p.)Description based upon print version of record.981-4411-21-3 Includes bibliographical references.pt. 1. Introduction -- pt. 2. Medical device safety and related ISO standards -- pt. 3. Harmonization of medical devices in Asia -- pt. 4. Medical device regulatory system in the United States and the European Union -- pt. 5. Medical device regulatory system in Asia-Pacific region.Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. Handbook of Medical Device Regulatory Affairs in Asia covers medical device regulatory systems inMedical instruments and apparatusSafety regulationsAsiaMedical instruments and apparatusStandardsMedical instruments and apparatusSafety regulationsMedical instruments and apparatusStandards.610.284Wong Jack.1495394Tong Raymond(Raymond Kai-yu)959181MiAaPQMiAaPQMiAaPQBOOK9910786112503321Handbook of medical device regulatory affairs in Asia3719472UNINA