Xiangyu Medical Accelerates Global Expansion with CE and FDA Certification Efforts

Dec 19, 2023 00:09 CST Updated 00:09

Sunnyou

Intelligent Rehabilitation Equipment R&D and Manufacturer

Source: Siyu MedTech; Editor: Zheng Siyu

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2023December 13,Sunnyou Medical (688626)Disclosed the record of investor relations activities in December.

Regarding the progress of the overseas expansion plan, Sunnyou Medical stated,After more than 20 yearsAfter years of market cultivation and brand building, the company has gained certain competitiveness internationally and established a customer base and brand recognition both at home and abroad, thanks to its excellent product quality and comprehensive service system.

To accelerate the overseas expansion process,The company has established a registration department under the International Business Department, specifically responsible for CE, FDA, and other countries' certifications.

In addition, in order to leverage the advantageous technical resources from various regions, the company hasEstablished long-term research cooperation with 12 countries, 39 research institutions and enterprises, and set up R&D centers in the headquarters, Shenzhen, Shanghai, Nanjing, Tianjin, Zhengzhou, Chengdu and other places.

At the same time, the companyEstablished foreign trade offices, forming a research and development system geared towards global demands. With years of continuous research and development, the company has achieved multiple products that fill domestic gaps in China and possess certain competitiveness in terms of exports.

# About Sunnyou Medical

Sunnyou Medical was founded in 2002 and isA comprehensive product manufacturing and service provider in the field of rehabilitation equipment, providing a series of rehabilitation products and comprehensive solutions to medical institutions at all levels in China, elderly care facilities, disabled rehabilitation centers, welfare homes, educational systems, and households.

Sunnyou has been deeply engaged in the "full track" of comprehensive rehabilitation for more than two decades, and has developed into a manufacturer covering a relatively complete product system in the field of rehabilitation medicine.Own products include:Rehabilitation assessment equipment, rehabilitation training equipment, rehabilitation physiotherapy equipment, rehabilitation aids, rehabilitation nursing equipment. CompanyCurrentlyHas obtained nearly 400 registration certificates/filing certificates, more than 600 varieties,A product system with more than 1,000 models has formed 38 clinical specialty solutions, demonstrating the capability for integrated clinical rehabilitation across the entire hospital and integrated regional health and wellness development.

The company continues to increase its R&D investment and innovation platform construction, focusing on the layout of frontier technology fields such as "brain-computer interface, artificial intelligence, and rehabilitation robots." It develops high value-added AI medical devices to maintain competitive advantages in solution capabilities and scientific research innovation.

# What isCE Certification？FDA certification?

1.CE Certification

CE Mark, also known as CE Marking, is the English term for "CE Marking." The letters "CE" are an abbreviation of the French phrase "Conformité Européene," which means "European Conformity."

CE is a safety certification mark.，Regarded as the passport for manufacturers to open and enter the European market.

In the EU market, the "CE" mark belongs toCompulsory Certification Mark, whether it is products produced by companies within the EU or products produced in other countries,If exporting to any of the 30 member countries of the European Economic Area (EEA), including the European Union (EU) and the European Free Trade Association (EFTA), CE certification may be required.Affix the CE Mark to the Product, to demonstrate that the product complies with the essential requirements of the EU's "New Approach to Technical Harmonization and Standardization" directive.

Since May 2021, medical device manufacturers must comply with the EU Medical Device Regulation 2017/745 instead of the Medical Device Directive 93/42/EEC., in order to obtain CE mark approval. Therefore, medical devices must be based onEU Medical Device Regulation (MDR) for classification.

2.FDA Certification

U.S. Food and Drug Administration(Food and Drug Administration)Abbreviation: FDA, the FDA is one of the enforcement agencies established by the U.S. government within the Department of Health and Human Services (DHHS) and the Public Health Service (PHS). As a scientific management organization,The FDA's responsibility is to ensure the safety of foods, cosmetics, drugs, biological products, medical devices, and radiological products produced domestically or imported into the United States.It is one of the earliest federal agencies with the primary function of protecting consumers.

FDA certification is the market access certification requirement by the U.S. Food and Drug Administration (FDA) for medical devices. By obtaining FDA certification, a product meets the quality and safety standards of the U.S. market.

The FDA manages medical devices through the Center for Devices and Radiological Health (CDRH), which oversees that manufacturers, packagers, and distributors of medical devices conduct their business operations in compliance with the law.

The scope of medical devices is very broad, ranging from medical gloves to heart pacemakers, all of which are under the supervision of the FDA, based on their medical uses and potential harm to the human body.FDA Divides Medical Devices into Class I, II, III, Class III represents the highest risk level, and the product classification and management requirements for each type of medical device are clearly stipulated.

Editor-in-Chief | Zhao Qing Reviewed by | Yi He