AOJ Medical Receives CE(MDR) Certificate Under the New European Medical Device Regulation
AOJ Medical, a product-focused provider of medical device supply chain services, has received CE (MDR) certificate in compliance with the new European…
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.
