Global Medical Device Regulation tihkhauh a nih tak avangin Europe leh American market-a lut ram pawn lama company-te chuan complex pre-market approval requirements chauh ni lovin, stringent flying inspection (no notice inspection) leh post-market surveillance (PMS) te pawh an tlin a ngai a ni. US FDA leh EU MDR/IVDR te hi regulatory logic, inspection method leh penalty ah te danglamna nasa tak a awm a ni.
What is FDA (US Food and Drug Administration) ? FDA hian United States-a damdawi hmanrua te himna leh a thatna tur a enkawl a. Device tam zawk tan chuan siamtute chuan an thil siam chu a him a, a hlawk zawk a, a hman tawh device awm tawh nen a inang tlang hle tih finfiah turin 510(k) an thehlut tur a ni.
MDR (Medical Device Regulation) chu ? MDR chu European Union-in medical device-te tana dan a siam a ni a, MDD hlui (Medical Device Directive) thlaktu a ni. Damlote himna leh langtlang zawka kalpui theihna turin clinical evaluation, post-market surveillance, leh technical documentation-ah te mamawh khauh zawk a nei a ni.
FDA leh MDR pahnih kal hi a buaithlak hle a—mahse a pawimawh hle. Joytech-ah hian kan sumdawnna puite’n heng thil phut mamawh tak takte hi rintlak taka an tlin theih nan global compliance system nghet tak kan siam a ni. US-a i inzarpharh emaw, MDR hnuaia EU-a i luh emaw pawh nise, kan certified products, technical documentation, leh regulatory expertise te chu i thlawp turin a awm a ni.
W hats 1000 . ni a ?
Joytech-ah hian khawvel puma kan thawhpui te tihchakna tur regulatory foundation nghet tak kan din a. Joytech chuan medical market lian hrang hranga khawvel pum huapa regulatory requirements zawm thei compliance framework kimchang leh hmalam thlir mek a siam a.
FDA 510(k) tihthianghlimna tur a ni.
Joytech hian hun rei tak chhung chu US market-ah hian awmna nghet tak a lo din tawh a, kan core product line zawng zawng chu FDA-in a tifai vek tawh a , global partner-te hnenah active takin a supply tawh bawk. He certified foundation hi dinin, clinical needs leh partner-specific project demands evolving tak tak phuhruk nan product innovation leh regulatory renewal-ah sum kan seng chhunzawm zel a ni.
Kum 2025 khan FDA portfolio chu certification thar engemaw zat nen kan tizau a:
Tubeless upper arm blood pressure monitors — portability leh user experience tihchangtlunna a pe.
Large-Arm Digital BP Monitors (DBP‐6186 / 6286b) — Arm size zau tak (40–56 cm) atana siam, Bluetooth option nei.
Joytech hi Chinese manufacturer zingah EU MDR certification nei hmasa ber zinga mi a ni a, hei hi regulation thar hnuaiah a ni. -ah khan April 2022 Tüv Süd atangin kan MDR certificate hmasa ber kan dawng a, chu chu digital thermometers, infrared thermometers (ear & forehead), breast pump, leh non-invasive blood pressure monitors ang chi products te a ni— China-a MDR phalna hmasa ber chu electronic thermometer leh breast pump te pawh a huam tel a ni.
Chumi hnuah chuan kum tin kan MDR-certified portfolio chu kan tizau zel a. thleng khan Kum 2023 October thla thisen sang monitor leh thermometer thar zawng zawng chuan CE (MDR) pawmpuina an dawng tawh a ni. atang khan February 2025 kan batch lina chu: certified products
Hetianga a lo zau zel hian Joytech-in zawm tur, product innovation, leh regulatory excellence lama a inpekna thuk tak a lantir a ni. Kan product lifecycle kimchang—design, testing, manufacturing, documentation, leh post-market surveillance—chu Europe-a standard khauh ber berte a ni a, EU ram puma certified, ready-to-market solution hmanga kan thawhpui te chu a tichak a ni.
Regulatory standard dangte .
Kan thil siam dan hi ISO 13485 leh MDSAP hnuaiah certified a ni a, US, Canada, Australia, Japan, leh Brazil-te regulatory needs a phuhruk a ni.
Tin, joytech products pawh NMPA (China), ROHS nen a inmil a, reach directives, Asia leh EU huam chhunga safety, environmental, leh documentation standards zawm te pawh a awm bawk.
Kan thawhpui te tan eng nge a awmzia .？
Joytech nena thawh dun hian thil siam chhuah (product) sourcing mai ni lovin thil dang a kawk a ni—chu chu international compliance-a thil harsa tak takte hrethiam thei tur strategic partner neih a ni.
v regulatory risk leh costs hniam zawk – kan ready-to-go certifications leh global audit lama kan tawnhriat te hian i local registration process-a phurrit a tihziaawm.
v Market access rang zawk – Pre-certified device hmang hian i target region-ah speed sang zawk leh delay tlem zawk hmangin i launch thei ang.
v Technical leh clinical support customized – Technical documentation atanga clinical data thlengin kan in-house regulatory team chuan i ram hrang hranga i mamawh phuhruk nan tailored support an pe a.
V Proven quality leh audit readiness – Kan quality system hian third-party audit tam tak a paltlang tawh a, kan documentation pawh audit-ready-a dah reng a ni a, langtlang leh efficiency a awm theih nan.
Thutlukna: Regulations a lo thang zel angin, keini pawhin kan ti ve ang. Joytech chuan a global compliance roadmap chu ang chi certification hmanga tihzauh zel a tum a ni FDA leh MDR —kan thawhpuiten regulated market-a certified, high-quality medical devices an hmuh theih lohna tura tih a ni.
Khawvel hmun pawimawh hrang hrangah certification kan nei tawh a, chung zingah chuan North America, EU, Asia leh a chhehvel pawh a tel.
I market-a certified kan nih leh nih loh hriat duh em?
Regulatory-ready OEM/ODM solution i zawng em?
Vawiin hian kan team te nen inzawm la, i project atana product certification details, technical documentation, leh tailored solutions te chhui rawh. Joytech hmang hian compliance chu i competitive advantage a lo ni ta a ni.
