WholeLife Co., Ltd., the authorized representative of the P-Cure Proton Therapy System, is pleased to announce that the system’s manufacturing facility officially passed the Quality System Documentation (QSD) review by the Taiwan Food and Drug Administration (TFDA) on December 11, 2025.

A Major Milestone Toward Excellence in Quality

Receiving QSD approval signifies that the P-Cure manufacturing site’s quality management system fully complies with the rigorous requirements of Taiwan’s Medical Device Act and the Regulations Governing the Excellence of Medical Device Quality Management Systems. This achievement is not only a critical entry threshold for P-Cure products into the Taiwan market but also reinforces our steadfast commitment to introducing high-specification, premium-quality medical equipment.

Future Outlook

Guided by the principle of integrity, our company is dedicated to introducing medical devices that meet international standards and regulatory requirements. This successful QSD approval establishes a solid foundation for subsequent product registration and market promotion. We will continue to deepen our presence in the Taiwan healthcare market, bringing in advanced technologies to enhance local medical capacity and service quality.