Ni 28 th khan .April 2022 khan Joytech chuan kan non-invasive blood pressure monitor te tan EU MDR initial issuance a hmu a,a chipchiar zawng chu i hre thei ang hetah.
Kum 2023-ah chuan Joytech contact thermometer, non contact thermometer leh blood pressure monitor thar te chu EU MDR pawmpui vek a ni.
CE(MDR) tih hi eng nge ni?
CE certificate chungchang sawi dawn chuan mi zawng zawngin kan hre chiang hle.Industry zawng zawng deuhthaw hian a inmil CE certification an nei vek a.MDR hi European Medical Device Regulation tih tawi a ni a, hei hi CE (MDD) update a ni a, medical devices himna leh hnathawh dan tur chungchangah thil tul sang zawk a siam a ni.CE(MDR) kan ti bawk.
CE(MDD) leh CE(MDR) te hi eng nge an danglamna?
MDR hi regulation a ni a, MDD hi directive a ni.Upgrade a nih avangin directive atanga regulation thlengin EU member ramte chuan certification process leh result-ah thuneihna khauh zawk an nei dawn a ni.
A bik takin a hnuaia thilte hi a lang chiang hle:
1) Thil siamtu mawhphurhna a tichak.
a) Thil siamtu chuan damdawi lam hmanrua lama thiamna nei compliance officer pakhat tal a nei tur a ni (MDD directive-ah hian chiang taka tih tur a awm lo)
b) Thil siamtu chuan technical documentation a siam ang a, a update chhunzawm zel ang a, national competent authority-in a dil hunah a awm theih nan a enfiah ang.
c) Technical documents update leh system enkawl dan tur enfiah turin thil siamtute chuan engtik lai pawhin notified body-te’n puan loh enfiahna an dawn chuan an chhang tur a ni(Class II thil siam chhuah) .
d) Trading company-te thil siam risk sang tak tan chuan CE dil a harsa zawk ang.
2) Regulatory provision tihpun leh certification review khauh zawk siam.
a) Classification dan tihpun: MDD-ah 18 aangin MDR-ah 22-ah;
b) Basic requirements checklist items tihpun a ni: MDD-a item 13 atanga MDR-a item 23-ah;
c) CE technical documents structure a danglam a, hetiang hian then a ni: product technical documents leh post-marketing documents (MDD hian product technical documents chauh a mamawh a);
d) Clinical evaluation report tih a ni.MDR chuan company-te chu clinical evaluation report version palina pe turin a ti a, hei hi version pathumna aiin a khauh zawk a;
3) A hman theihna tur zau zawk
a) MDD hian damdawi atana hman tur thil siam chauh a target a, MDR erawh chuan damdawi ni lo hmanrua thenkhat chu hmanna huam chhungah a huam a, chu chu thlai contact lens, beauty product, etc. te hi a ni
b) MDD-ah chuan reusable devices chu medical device class-ah dah a ni a, notified body-in a inrawlh a ngai lo va, MDR-ah chuan notified body-in reusable surgical devices-te conformity assessment a neih a ngai thung
4) MDR hian langtlang leh zawn chhuah theihna nasa zawk a mamawh a ni
a) Product traceability tihpun nan unique device identifier UDI a rawn hmang a;
b) Company chungchanga thu pawimawh tak takte chu European Medical Device Database (EUDAMED)-ah dahkhawm a ni ang a;
c) Post-market surveillance (PMS) system siam;
d) Notified body chuan puan loh enfiahna a nei ang.
MDR CE hi eng clinical evaluation nge ni?
Kan sawi tum clinical practice hi a tlangpuiin chi hnih ah then a ni a:
a) Mihring chungah clinical trial hmangin a him leh him loh finfiah nan data lak a ni.
b) Clinical report-ah hian product tehkhin (aspect pathum aangin: clinical data, technical parameters, leh biological performance), data analysis, leh literature review hmangin product him leh tangkaizia a finfiah ber a ni.
c) Clinical evaluation report hi CE technical document-a tel a ni a, key component a ni bawk (CE certification dil hunah CE technical document-a report pawimawh tak a ni).
d) Tunah hian clinical evaluation report version palina chu kalpui a ni a, chu chu clinical evaluation guideline MedDev 2.7.1 angin clinical evaluation report siam a ni.
MDR certification pass tihna a ni Joytech hmanga thisen sang enfiahna leh digital thermometer hian design, production leh quality control-ah standard khauh tak a thleng tawh a, khawvel hmun hrang hranga hmangtute tan damdawi hmanraw him zawk leh rintlak zawk a pe thei a ni.
Joytech blood pressure monitor leh digital thermometer te hian an tehna result dik tak, user-friendly design leh performance tha tak an neih avangin hmangtute zingah lungrual takin fak an hlawh hle.Tunah chuan MDR certification an pass tawh a, hei hian rinhlelh rual lohvin kan thil siamte chunga hmangtute rinna leh lungawina a tipung lehzual dawn a ni.
Joytech Healthcare chuan a pe chhunzawm zel dawn a ni damdawi hmanraw tha tak tak leh khawvel hmun hrang hranga hmangtute hriselna atana thawhhlawk tak takte a ni.Kan thawhrimna hmang hian kan thil siam quality tha tak takte hian khawvel pum huap market-a i nun hrisel tak atan a pui dawn niin kan ring.
Kan blood pressure monitor leh thermometer products chungchanga zawhna leh mamawh i neih chuan min rawn zawt thei ang.
