Company News

AOJ Medical Receives CE(MDR) Certificate Under the New European Medical Device Regulation

Views : 254
Author : AOJ Medical
Update time : 2022-11-04 15:32:48
AOJ Medical, a product-focused provider of medical device supply chain services, has received CE (MDR) certificate in compliance with the new European Medical Device Regulation (MDR (EU) 2017/745) in October, 2022. 

The CE(MDR) certificate includes all product lines of AOJ medical: non-invasive blood pressure monitors(NIBP), pulse oximeters and digital thermometers, which makes AOJ Medical become the first batch of medical device manufacturers in China who have obtained the CE(MDR) certificate, issued by TÜV SÜD.
CE(MDR) Certificate

As the “VISA” to enter the EU (European Union) market, CE certificate is the critical requirement for all the product which can be sold in EU. The MDR (Medical Device Regulation) has replaced the previous MDD (Medical Device Directive) since May 2020, with the aim to establish a modernized and more robust EU legislative framework to ensure better protection of public health and patient safety.

Compared with the Medical Device Directive (MDD), the MDR is stricter in product risk management, product performance safety standards, clinical evaluation, and post-market vigilance and supervision. At the same time, it is also a challenge to the medical manufacturer's quality management system, product safety, and effectiveness.

AOJ Medical pay great attention to global certifications
As a medical device manufacturer, since established, AOJ Medical has consistently invested in R&D as well as quality and regulatory compliance. 

AOJ Medical will take this opportunity to pay more attention to product quality and safety, and continue to help our customers develop the EU market and the global market.
Related News
Read More >>
AOJ Medical RPM Products Shows at CMEF AOJ Medical RPM Products Shows at CMEF
Nov .24.2022
The 86th China International Medical Equipment Fair (CMEF) started in Shenzhen on November 23, 2022. AOJ Medical presented new RPM (Remote Patient Monitoring) products at Hall 10, Booth 10D45.
AOJ Medical Showcases New Vital Signs Monitoring Devices at MEDICA AOJ Medical Showcases New Vital Signs Monitoring Devices at MEDICA
Nov .18.2022
MEDICA 2022 ended successfully. AOJ Medical's vital signs monitoring products got the attention of many customers
AOJ MEDICAL Attend MEDICA Trade Fair 2022 AOJ MEDICAL Attend MEDICA Trade Fair 2022
Nov .15.2022
On 14th November 2022, MEDICA More than 4000 companies from more than 70 countries and regions participated in the exhibition. AOJ Medical team attended MEDICA with our vital signs monitoring devices on the international stage.
9 of 10 People Measure Blood Pressure Incorrectly! 9 of 10 People Measure Blood Pressure Incorrectly!
Aug .17.2022
When measuring blood pressure at home, the value fluctuates up and down. Some people suspect that the blood pressure is "inaccurate"; others worry that their blood pressure is "out of control". In fact, the reason why many people's blood pressure values a