Certification
MFDS (KFDA)
• MFDS certification of other software, class II, for in-vitro diagnosis 24-875 (Qanti IHC) • MFDS certification of digital medical device software, 25-4006 (Qanti Ki-67 Micro) The Ministry of Food and Drug Safety (MFDS) is responsible for evaluating and managing the safety and effectiveness of medical device, including the certification of in vitro diagnostic (IVD) medical devices and digital medical device. IVD medical devices analyze specimens such as blood, urine, and tissues to diagnose diseases without being inserted into the human body. Digital medical devices software incorporate technologies such as artificial intelligence (AI) and software (SW) to support disease diagnosis, treatment, and health management. Through this certification process, IVD medical devices and digital medical devices software approved by the MFDS are proven to be safe and effective, making them reliable for use by both medical institutions and individuals.
Products:
ISO 13485:2016
ISO 13485 is an international standard for quality management systems in the medical device industry, serving as the basis for domestic GMP (Good Manufacturing Practice for medical devices) audits. It is a fundamental certification commonly recognized for meeting regulatory requirements for medical devices worldwide, making it essential for entering the global medical device market.
GMP (KTL-CABA-20982)
It is a quality management system that defines the requirements to ensure the quality of medical devices across all processes, from development to raw material procurement, manufacturing, inspection, packaging, installation, storage, shipment, and handling of claims or returns, to ensure a consistent supply of high-quality products. Certification is essential to guarantee that medical devices produced by manufacturers are safe, effective, and consistently meet the intended use at a high level of quality.