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

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.

Previous : AOJ MEDICAL Attend MEDICA Trade Fair 2022

Next : FIME 2022 Completed Successfully

Hong Kong Electronics Fair (Autumn Edition)

Oct .16.2024

Our booth was like a treasure trove of health. There are brand new blood pressure monitors here, accurately controlling the dynamics of blood pressure and protecting your cardiovascular health.
Thermometer, small but powerful, quickly and accurately meas

2024 CMEF Shenzhen

Oct .16.2024

On October 12, our booth made a wonderful debut, with an accurate and reliable sphygmomanometer to protect your health at any time, a sensitive and convenient thermometer to keep an eye on your body temperature changes, and an oximeter that can quickly de

Kind + Jugend 2024

Sep .06.2024

The theme of our booth is rich and varied products, including the intimate breast pump, which provides mothers with convenience and comfort; the accurate thermometer, which always guards the healthy temperature of the whole family; the practical nasal asp

Medical Fair China 2024 came to a successful conclusion!

Aug .26.2024

Our booth attracted a lot of attention with the theme of “Vital signs monitoring”, “Maternity & Children Baby Medical Device” and “One- stopBlood Pressure MonitorManufacturer”. stop Blood Pressure Monitor Manufacturer” as the theme, attracted a lot of att