on 28 Th . April 2022 khan Joytech chuan kan non-invasive blood pressure monitors te tan EU MDR initial issuance a hmu a,a chipchiar zawngin i hmu thei ang hetah.
Kum 2023 khan joytech contact thermometers, non contact thermometers leh blood pressure monitor thar te chu EU MDR pawm vek an ni.
CE,MDR chu eng nge ni?
CE certificate chungchang sawi dawn chuan mi zawng zawngin an hre vek a ni. Industry zawng zawng deuhthaw hian a inmil CE certification an nei vek. MDR hi European Medical Device Regulation tih tawi a ni a, hei hi CE (MDD) update a ni a, damdawi hmanrua himna leh hnathawh danah thil mamawh sang zawk a siam a ni. Tin, CE-a kan ti bawk a,mdr).
CE,MDD) hi eng nge a danglamna, CE,MDR)
MDR hi regulation a ni a, MDD hi directive a ni. Upgrade a nih avangin, directive atanga regulation thlengin EU Member State te chuan certification process leh result chungchangah thuneihna khauh zawk an nei ang.
A bik takin a hnuaia thil awmte hi a lang chiang hle:
1) Thil siamtu mawhphurhna a tichak.
a) thil siamtu chuan damdawi hmanrua lama thiamna nei compliance officer pakhat tal a neih a ngai a (MDD Directive-ah hian thil tih tur chiang tak 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 document update leh system enkawl a nih theih nan engtik lai pawha hriattir loha hriattir loh enfiahna chu thil siamtute chuan an chhang tur a ni (Class II Thil siam chhuah) .
d) Trading company-te thil siam hlauhawm tak takte tan chuan CE dil a harsa zawk ang.
2) Regulatory provision tihpun leh certification enfiah khauh zawk.
a) Classification rules tihpun: MDD-a 18 aṭanga MDR-a 22-ah;
b) Basic requirements checklist items te chu tihpun a ni: MDD-a thil 13 atanga MDR-a thil 23 thleng;
c) CE technical documents siam dan a danglam a, chu chu: Product Technical Documents leh Post-Marketing Documents (MDD chauh hian product technical documents a mamawh);
d) clinical evaluation report a ni. MDR chuan company-te chu clinical evaluation report palina, a pathumna aiin a khauh zawk a, a khirh zawk a ni;
3) A hmanna tur scope tihzauh .
A) MDD hian damdawi lam thila thil siamte chauh a target a, MDR erawh chuan hmanna hmun (scope of application) ah hian non-medical device thenkhat, vegetable contact lens, beauty products, etc. te a dah tel a
b) MDD-ah chuan hman nawn theih hmanrua chu damdawi hmanrua class anga dah a ni a, notified body-in a inrawlh a ngai lo va, MDR chuan notified body-in reusable surgical device-te conformity assessment a neih a ngai a
4) MDR hian transparency leh traceability nasa zawk a mamawh a ni .
a) Product traceability tihpunna tur device identifier UDI unique tak chu a rawn luh tir a;
b) Company-in thu pawimawh a neihte chu European Medical Device Database (Eudamed)-ah a la lut ang a;
c) Post-market surveillance (PMS) system siam;
d) Notified body chuan hriattir loh enfiahna a nei ang.
MDR CE hi eng clinical evaluation nge a nih?
Kan sawi tum clinical practice hi a tlangpuiin chi hnih ah then a ni a:
A) Clinical trial hmangin mihringte chu an thil siam him leh him loh finfiah nan data an la thin.
b) Clinical report-te chuan product tehkhin (three aspects: clinical data, technical parameters, leh biological performance), data analysis, leh literature review hmangin product tehkhin dan (aspect pathum aangin) a himna leh a angkaizia a finfiah ber a ni.
c) Clinical evaluation report hi CE Technical Document-a tel a ni a, key component a ni bawk (Clinical Evaluation Report hi 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 report a ni a, clinical evaluation guideline Meddev 2.7.1 angin a siam a ni.
MDR certification pass tih awmzia chu . Joytech thisen sang enfiah leh . Digital thermometer hian design, production leh quality control-ah standard khauh tak a siam a, khawvel hmun hrang hranga hmangtute tan damdawi hmanrua him leh rintlak zawk a pe thei bawk.
Joytech Blood Pressure Monitor leh Digital Thermometer te chuan an tehna result dik tak, user-friendly design leh performance tha tak an neih avangin users te hnen atangin fakna lungrual tak an dawng a ni. Tunah chuan MDR certification an pass tawh a, hei hian kan thil siamah hian users-te rinna leh lungawina a tipung lehzual dawn tih rinhlelh rual a ni lo.
Joytech Healthcare chuan 2018 a pe chhunzawm zel dawn a ni. damdawi hmanrua tha tak tak leh khawvel hmun hrang hranga hmangtute hriselna atana thawhhlawk tak a ni. Kan thawhrimna hmang hian kan thil siam quality te hian khawvel market-a i nun hriselna atan a puih ngei kan ring.
Kan thisen sang monitor leh thermometer product chungchanga zawhna emaw mamawh emaw i neih chuan min rawn biak theih reng e.
