MFDS launches ‘CAPA Helper’ program for noncompliant medical device manufacturers

The Ministry of Food and Drug Safety (MFDS) is launching the “CAPA Helper” program to prevent the recurrence of noncompliant medical devices and improve quality management at small businesses.

The MFDS said on the 16th that it will implement the “CAPA Helper Operation for Medical Device Quality Improvement” program with the Daegu-Gyeongbuk Medical Innovation Foundation. “CAPA” (Corrective Action & Preventive Action) refers to corrective and preventive actions taken to identify the cause of a nonconformity and prevent its recurrence.

The program targets domestic medical device companies found to have failed collection and inspection requirements, produced products with foreign matter, or violated quality management requirements. External experts will visit manufacturing facilities in person to analyze the causes and provide tailored solutions.

The measure takes into account the industry’s structure, in which more than 80% of domestic medical device manufacturers are small businesses with annual production valued at less than 1 billion won. The goal is to fundamentally prevent the recurrence of noncompliant products by strengthening small businesses’ quality management capabilities.

This year’s program will run through November for companies that wish to participate. It will include on-site assessments by experts, technical support from an external expert group, and effectiveness verification through satisfaction surveys.

An MFDS official said, “The core of the program is to provide companies where nonconformities have occurred with practical opportunities to improve quality,” adding, “We will continue to support efforts to strengthen quality management capabilities at manufacturing sites so that people can use medical devices with confidence.”