Won Saudi SFDA Authoritative Certification, Ruipu Medical Adds Another Heavyweight Milestone to Its Internationalization Strategy

From Product to System: Passing the Strict Review of Saudi SFDA

Pulmonary hypertension and respiratory failure are major challenges in the treatment of critical illnesses. With years of technological accumulation in the field of inhaled nitric oxide therapy, Ruipu Medical successfully passed the evaluation of the Saudi Food and Drug Authority (SFDA). This authorization not only covers the main unit system, but also includes a full set of consumables such as disposable corrugated tubes, neonatal/adult connectors, and disposable split-flow mixers in the scope of approval, achieving coverage of clinical scenarios for patients of all ages, from adults to neonates. This marks that Ruipu has established a complete solution capability from "core equipment" to "supporting accessories," laying a solid product foundation for entering the high-end respiratory support market.

Saudi SFDA Certification: An Access Credential for the Middle East's High-End Medical Market

As one of the largest and most stringent medical device markets in the Middle East, Saudi Arabia's SFDA certification is regarded as an important threshold for entering the region. Obtaining this authorization means that Ruipu's products can be legally sold and used in hospitals and medical institutions within Saudi Arabia, providing a compliance basis for subsequent participation in local tenders and clinical procurement.

Compliance Capability: A Reflection of Corporate Responsibility

Amid the trend of continuously strengthening medical device regulation globally, whether a company can meet the regulatory requirements of different countries is directly related to its sustainable development. The MDMA authorization obtained by Ruipu this time strictly complies with the provisions of the Saudi Royal Decree "Medical Devices Law," covering the full-process requirements from product design and clinical

evaluation to post-market management. Ruipu always insists on internalizing compliance as a daily operational standard, thereby winning the trust of users and partners.

Continuous Improvement: Every Certification Is a New Starting Point

Obtaining the Saudi SFDA authorization is not the end, but the starting point for further expanding into international markets. Ruipu will continue to track regulatory developments in various countries, continuously improve its quality management system, and ensure product safety and quality in an institutionalized and systematic manner.