Philosys Obtains Medical Device Single Review Program Certification... Exemption from Certification Reviews in 5 Countries Including the US and Japan

[Asia Economy Reporter Eunmo Koo] Philosis, an affiliate of Philosis Healthcare, announced on the 15th that it has obtained MDSAP (Medical Device Single Audit Program) certification for five countries: the United States, Canada, Japan, Australia, and Brazil.

MDSAP (The Medical Device Single Audit Program) is a certification system created by the International Medical Device Regulators Forum (IMDRF) to ensure the safety and quality management of medical devices. Currently, the countries participating in MDSAP are the United States, Canada, Japan, Australia, and Brazil. The program conducts a single audit to determine whether the manufacturer's production process and product quality meet the medical device standards of these five countries, and then decides on MDSAP certification.

Companies that obtain MDSAP certification are fully or partially exempted from medical device certification audits in the five countries: the United States (FDA), Canada (Health Canada), Japan (MHLW), Australia (TGA), and Brazil (ANVISA). This not only saves time and costs required for approval but also serves as a strong proof of quality since MDSAP is one of the most stringent certification systems in the medical device field.

Additionally, companies with MDSAP certification are recognized for their quality systems to the extent that the U.S. Food and Drug Administration (FDA) exempts them from on-site inspections of manufacturing facilities. With this certification, Philosis and its affiliate Philosis Healthcare are expected to gain momentum in exporting diagnostic kits.

This content was produced with the assistance of AI translation services.