Company News

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

Views : 1906
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 participated in the 2024 Spring Canton Fair. AOJ MEDICAL participated in the 2024 Spring Canton Fair.
May .07.2024
AOJ MEDICAL 2024 Spring Canton Fair continues to be hot!
This exhibition will present a series of high-quality medical equipment, including thermometer, oximeter, sphygmomanometer and maternal and infant products!
The 2024 Thailand Mother & Baby Show concluded successfully The 2024 Thailand Mother & Baby Show concluded successfully
Apr .28.2024
The atmosphere at AOJ MEDICAL 2024 Thailand Mother & Baby Show was electric! It is a place where the industry's cutting-edge mother and baby products and superb value for money are brought together.
The spring 2024 Hong Kong Electronics Show came to a successful conclusion. The spring 2024 Hong Kong Electronics Show came to a successful conclusion.
Apr .17.2024
Hello everyone! Welcome to Spring 2024 Hong Kong Electronics Show. With the theme of "One-stop blood pressure monitor manufacturer, Maternity & Children Baby Medical Device and Vital signs monitoring", we present you with a series of innovative medical eq
Shanghai CMEF opened, and the atmosphere was very warm! Shanghai CMEF opened, and the atmosphere was very warm!
Apr .15.2024
The atmosphere at CMEF Shanghai Exhibition is very warm! The cutting-edge medical equipment and solutions are gathered here to jointly display the latest medical technology and achievements.