Chung-Ang University Hospital Obtains Certification as an International Medical Device Clinical Trial Institution

Exterior view of Chung-Ang University Hospital.

[Asia Economy Reporter Lee Gwan-joo] Chung-Ang University Hospital announced on the 29th that it has obtained international medical device clinical trial institution certification (ISO14155 certification) from T?V S?D, a global testing and certification organization based in Germany.

With this certification, domestic medical device manufacturers can secure clinical trials and clinical data for medical devices according to the ISO14155 standard (international standard for clinical trials of medical devices on humans - GCP) through Chung-Ang University Hospital, enabling active response to the enhanced European Medical Device Regulation (MDR).

Since May of last year, all medical devices launched in the European Union (EU) market must comply with the European Medical Device Regulation, and clinical data based on the ISO14155 standard must be submitted mandatorily when applying for CE certification. Until now, domestic medical device manufacturers had to mainly outsource clinical trials to overseas medical institutions to obtain certifications (FDA, CE, etc.) for entry into overseas markets such as the US and Europe, which led to increased development costs and extended development periods for medical devices.

Lee Han-jun, director of Chung-Ang University Hospital, said, “With this certification, Chung-Ang University Hospital will enhance the safety and efficacy of domestically produced medical devices to international standards and further contribute to the activation of global market entry of Korean medical devices by promptly responding to international regulations.”

Since May of last year, Chung-Ang University Hospital has opened a Clinical Trial Center to ensure scientific and ethical clinical trials according to international standards such as KGCP (Korean Good Clinical Practice for pharmaceuticals and medical devices), ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use), and ISO14155 guidelines, playing a leading role in usability testing of domestic medical devices and their overseas expansion.

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