MFDS Publishes Three MDSAP Audit Response Guidelines to Support Medical Device Exports

The Ministry of Food and Drug Safety (MFDS) has issued three MDSAP audit response guidelines to help South Korean medical device manufacturers enter overseas markets.

According to the MFDS on the 28th, the guidelines describe how manufacturers of three key device types, selected based on domestic medical device export performance and other factors, can prepare for audits to obtain MDSAP certification: electrosurgical units, tissue-engineered medical products and general-purpose ultrasonic imaging diagnostic devices.

The Medical Device Single Audit Program (MDSAP) is an international initiative under which five countries—the U.S., Canada, Japan, Australia and Brazil—jointly audit medical device manufacturing and quality management systems (GMP). MDSAP certification can exempt manufacturers from all or part of the GMP certification audits in those countries.

The devices covered by the guidelines are electrosurgical units (Class III), tissue-engineered medical products (Class IV) and general-purpose ultrasonic imaging diagnostic devices (Class II). Electrosurgical units use high-frequency electrical current for procedures such as cutting or coagulation. Tissue-engineered medical products are biologically derived materials used to replace, repair or reconstruct human tissues and organs, including blood vessels, the heart, septa, fascia and skin. General-purpose ultrasonic imaging diagnostic devices transmit ultrasonic energy to a patient’s affected area and receive reflected signals to produce diagnostic images.

The guidelines cover an overview of the MDSAP audit program, requirements of MDSAP member countries, audit characteristics by manufacturing process, audit criteria for sterile medical devices, and quality document forms and examples. They also include items to prepare for audits based on the characteristics of different medical devices, such as machinery and instruments, and materials and supplies.

The MFDS said it expects the guidelines to strengthen the audit response capabilities of domestic manufacturers preparing for MDSAP certification and help them enter overseas markets. The agency added that it will continue support programs to strengthen the global competitiveness of domestic companies.

Details are available on the MFDS website (www.mfds.go.kr) under Laws and Data → Legal Information → Guidance for Public Officials/Guides for Civil Petitioners.