Joytech Medical chu April 28, 2022 khan Tüvsüd Süd-in a tihchhuah EU Quality Management System Certificate (MDR) chu a dawng a, certification huam chhungah hian: Digital thermometer hmanga siam a ni., Thisen sang enfiahna ., Infrared ear thermometer, infrared forehead thermometer, multifunction forehead thermometer , electric hnute pump, manual breast pump. China rama CE compliance certificate chu Regulation MDR mamawh thara dawng hmasa ber pawl a ni a, domestic electronic thermometer, infrared ear thermometer leh breast pump-te tan MDR certificate hmasa ber a ni bawk.
Joytech Medical hi medical device enterprise a ni a, R&D, health monitoring leh chronic disease management atana medical device siam leh hralhna lam a ngaihtuah a ni. A din tirh aṭang khan company hi National High-Tech Enterprise leh Hangzhou-a high-tech R&D center enterprise anga pawm a ni tawh a ni. Joytech Medical chuan 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 a, marketing atan pawh pawm a ni. Tin, ram chhung leh ram pawnah pawh enterprise lar tak tak tam tak nen hun rei tak chhung atan strategic cooperation kan thleng tawh bawk.
EU hian Member State-te inkara sumdawnna lama harsatna awmte tihbo nan leh mipui, service, capital leh thil siam (medical device ang chi) te zalen taka a luang chhuah theih nan market lian takah a insiam zauh zauh mek a ni. Medical devices lamah chuan European Commission chuan Member State tinte original accreditation system thlak turin EU directive pathum a siam a, chutiang chuan chutiang thil hralh chhuah chungchanga dan siamte chu a inmil thei ang.
EU MDR hian EU-in official medical device regulation (MDR) a tihchhuah (Medical Device Regulation (EU) 2017/745) a sawi a, MDR Article 123-a thil tih turte aangin a sawi a ni. MDR hi May 26, 2017 khan hman tan a ni a, May 26, 2020 , Implantable Medical Devices Directive (AIMDD
Medical Device Directive (MDD) nen khaikhin chuan MDR hi product risk management, product performance leh safety standards, clinical evaluation bakah post-market vigilance leh products supervision lamah a khauh zawk a ni. Tin, siamtu quality management system leh product safety effectiveness tan pawh harsatna lian tak a ni bawk.
MDR certification hlawhtling taka an tihhlawhtlin hian Joytech Medical thil siamte standard leh quality sang tak leh EU market hriatpuina a lantir a ni. Joytech Medical chuan MDR CE certification chu hmasawnna hun remchang thar atan a la dawn a, hei hian khawvel puma market layout thuk zawk leh khawvel puma medical industry-a thawhpui turin a pui dawn a ni.
