LEADER 02664oam 2200577I 450 001 9910786112503321 005 20230803025725.0 010 $a0-429-07135-3 010 $a981-4411-22-1 024 7 $a10.1201/b14081 035 $a(CKB)2670000000343265 035 $a(EBL)1165926 035 $a(OCoLC)837602091 035 $a(SSID)ssj0000905630 035 $a(PQKBManifestationID)11563941 035 $a(PQKBTitleCode)TC0000905630 035 $a(PQKBWorkID)10927400 035 $a(PQKB)10744803 035 $a(MiAaPQ)EBC1165926 035 $a(Au-PeEL)EBL1165926 035 $a(CaPaEBR)ebr10681933 035 $a(CaONFJC)MIL501536 035 $a(EXLCZ)992670000000343265 100 $a20180331d2013 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 10$aHandbook of medical device regulatory affairs in Asia /$fJack Wong, Raymond K.Y. Tong 210 1$aBoca Raton, Fla. :$cCRC Press,$d2013. 215 $a1 online resource (610 p.) 300 $aDescription based upon print version of record. 311 $a981-4411-21-3 320 $aIncludes bibliographical references. 327 $apt. 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. 330 $aMedical 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 in 606 $aMedical instruments and apparatus$xSafety regulations$zAsia 606 $aMedical instruments and apparatus$xStandards 615 0$aMedical instruments and apparatus$xSafety regulations 615 0$aMedical instruments and apparatus$xStandards. 676 $a610.284 700 $aWong$b Jack.$01495394 701 $aTong$b Raymond$g(Raymond Kai-yu)$0959181 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910786112503321 996 $aHandbook of medical device regulatory affairs in Asia$93719472 997 $aUNINA