Medical Device Manufacturing and Quality Control Audit Procedures to Be Accelerated

MFDS Announces Administrative Notice of Revised Medical Device GMP Standards
Simultaneous Domestic and International GMP Assessments for Export Companies

The Ministry of Food and Drug Safety announced on the 11th the administrative notice of the revision of the "Medical Device Manufacturing and Quality Control Standards," which includes improvements to enable rapid approval of Good Manufacturing Practice (GMP) conformity assessments for medical devices, and will accept opinions until the 31st.

First, the Ministry plans to establish a "combined assessment" system that allows simultaneous evaluation of domestic GMP conformity certification and the Medical Device Single Audit Program (MDSAP) recognized by export countries. With this revision, medical device exporters can apply for both domestic GMP conformity assessment and MDSAP assessment as a combined assessment to the quality control assessment agency, enabling them to undergo two types of assessments simultaneously within the same period.

Additionally, to support expedited assessments, the Ministry has arranged for private quality control assessment agencies with expertise to conduct GMP assessments independently for Class 3 manufacturing and imported medical devices, which were previously conducted jointly by regional MFDS offices and quality control assessment agencies.

Following the enforcement of the Digital Medical Device Act in January, regulations for GMP assessments of software medical devices will also be revised.

The Ministry emphasized, "We will continue to improve the medical device GMP system to support the launch of innovative products applying advanced technologies, expand treatment opportunities for patients, and support the export of domestic companies."