Joytech Medical hi April 28, 2022 khan TüVSüD SÜD-in EU Quality Management System Certificate (MDR) a pe a, certification pekna huam chhungah hian: digital thermometer hmanga teh a ni, thisen sang enfiahna tur, infrared beng thermometer, infrared hmai thermometer, multifunction hmai thermometer , electric hnute pump, kut hmanga hnute pump.China rama regulation thar MDR requirements hnuaia CE compliance certificate dawng hmasa ber pawl a ni a, domestic electronic thermometer, infrared ear thermometer leh breast pump-a MDR certificate hmasa ber a ni bawk.
Joytech Medical hi medical device enterprise a ni a, R&D, hriselna enkawlna leh natna khirh tak enkawlna atana medical device siam leh hralhna lam a ngaihtuah a ni.A din tirh aṭang khan Hangzhou-ah national high-tech enterprise leh high-tech R&D center enterprise anga pawm a ni.Joytech Medical hian ISO13485, MDSAP leh quality management system dangte a paltlang tawh a ni.Kan thil siamte hian ram chhunga NMPA, US FDA, EU CE, Canada CMDCAS, Japan PMDA leh certification leh registration dangte kan hmu tawh a, hralh chhuah phalna kan nei tawh bawk.Tin, ram chhung leh ram pawna enterprise lar tam tak nen hun rei tak chhunga strategic cooperation kan nei tawh bawk.
EU hian member ramte inkara sumdawnna lama harsatna awmte tihbo a, mipui, service, capital leh thil siam (damdawi hmanrua ang chi) zalen taka an kal theih nan, unified market lian takah a insiam zau zauh zauh a ni.Medical devices lamah chuan European Commission chuan member state tinte accreditation system hmasa ber thlak turin EU directive pathum a siam a, chutiang chuan chutiang thil hralhna chungchanga dan siamte chu a inmil thei ang.
EU MDR tih hian EU-in official Medical Device Regulation (MDR) a tihchhuah (Medical Device Regulation (EU) 2017/745) a kawk a, hei hi MDR Article 123-a thil tulte atanga siam a ni.MDR hi May 26, 2017 atang khan hman tan a ni a, official-in Medical Device Directive hlui (MDD 93/42/EEC) leh May 26, 2020 atanga Active Medical Device Directive (AEDD) , Implantable Medical Devices Directive (AIMDD 90) te chu a thlak ta a ni /385/EEC hmanga tih a ni).
Medical Device Directive (MDD) nena khaikhin chuan MDR hi product risk management, product performance leh safety standard, clinical evaluation, bakah post-market vigilance leh product enkawl danah a khauh zawk a ni.Tin, siamtute quality management system leh product safety effectiveness-ah pawh harsatna lian tak a ni.
MDR certification hlawhtlinna hian Joytech Medical thil siamte standard leh quality sang tak leh EU market-a hriat hlawh a nihzia a tilang chiang hle.Joytech Medical hian MDR CE certification hi hmasawnna hun thar atan a hmang dawn a, hei hian khawvel market layout a thuk zawk a, khawvel medical industry-ah a thawhhlawk hle dawn a ni.
