Joytech Medical was awarded the EU Quality Management System Certificate (MDR) issued by TüVSüD SÜD on April 28, 2022. The scope of certification includes: digital thermometer, blood pressure monitor, infrared ear thermometer, infrared forehead thermometer, multifunction forehead thermometer, electric breast pump, manual breast pump. It is one of the earliest companies in China to get the CE compliance certificate under the new regulation MDR requirements, and is the first MDR certificate for domestic electronic thermometers, infrared ear thermometers and breast pumps.
Joytech Medical is a medical device enterprise focusing on the R&D, production and sales of medical devices for health monitoring and chronic disease management. Since its establishment, the company has been recognized as a national high-tech enterprise and a high-tech R&D center enterprise in Hangzhou. Joytech Medical has passed ISO13485, MDSAP and other quality management systems. Our products have obtained domestic NMPA, U.S. FDA, EU CE, Canada CMDCAS, Japan PMDA and other certifications and registrations, and have been approved for marketing. And we have reached long-term strategic cooperation with many famous enterprises at home and abroad.
The EU is gradually building into a large unified market to eliminate trade barriers between member states and ensure the free flow of people, services, capital and products (such as medical devices). In the field of medical devices, the European Commission has developed three EU directives to replace the original accreditation system of each member state, so that the regulations concerning the marketing of such products can be harmonized.
The EU MDR refers to the official Medical Device Regulation (MDR) issued by the EU (Medical Device Regulation (EU) 2017/745), based on the requirements of Article 123 of the MDR. the MDR entered into force on May 26, 2017 and officially replaces the former Medical Device Directive (MDD 93/42/EEC) and the Active Medical Device Directive (AEDD) as of May 26, 2020 , the Implantable Medical Devices Directive (AIMDD 90/385/EEC).
Compared to the Medical Device Directive (MDD), the MDR is more stringent in terms of product risk management, product performance and safety standards, clinical evaluation, as well as post-market vigilance and supervision of products. It is also a major challenge to the manufacturer's quality management system and product safety effectiveness.
The successful achievement of MDR certification demonstrates the high standard and quality of Joytech Medical's products and the recognition of the EU market. Joytech Medical will take the MDR CE certification as a new development opportunity to further deepen the global market layout and contribute to the global medical industry.