South Korea’s MFDS publishes draft regulatory revision and new guidance documents

South Korea’s Ministry of Food and Drug Safety (MFDS) solicited public feedback on a draft revision to its medical device regulatory system that would, among other changes, introduce a separate category for software as a medical device (SaMD). The regulatory body also released a series of guidance documents on medical respirators, digital treatment devices, innovative medical devices and software, and medical device re-evaluation.

Draft revision would introduce new and revised product classification codes

The MFDS held a period of public consultation for the draft revision to the Regulation on Medical Device Codes and Classification (Notice No. 2020-34, link in Korean), which ended on September 16. The proposed amendments include:

• A new category in the product classification system for SaMD, particularly innovative medical device software that employs artificial intelligence, virtual reality, and augmented reality technologies;
• a new category for medical respirators; and
• minor adjustments to existing medical device product classification codes.

The new software category is divided into 11 sub-categories, arranged according to fields of clinical practice (e.g., cardiovascular and neurological), and further subdivided into 90 more specific product groupings.

In a translated press release, the MFDS noted that the overall revision is intended to make it easier for South Korean manufacturers to export their products to the US and other markets with specific regulations for SaMD. It is also intended to serve as part of the foundation of a “smart” medical infrastructure in line with the principles of the recently announced economic stimulus plan dubbed the “Korean New Deal.”

MFDS publishes guidance documents on medical respirators and innovative devices

The MFDS released a guidance document titled Medical Respiratory Protective Equipment Licensing and Review Guidelines (Handbook-1048-01), outlining the approvals and examination processes for medical-grade respiratory protective equipment. The guidance also provides information on the required performance tests and technical data for submission, and it offers a comparison of the Korean regulations for these devices with international standards.

The MFDS additionally published several new device-specific guidance documents:

• Guidelines for the Approval/Examination of Digital Treatment Devices (Handbook-1045-01), which includes instruction on technical document preparation;
• Guidelines for the Step-by-Step Screening of Innovative Medical Devices (Handbook-1046-01), providing an overview of the initial screening process and application requirements for innovative devices; 
• Guidelines for Major Modifications in Innovative Medical Device Software (Handbook-1047-01), which specifies the types of modifications to innovative medical device software that require approval from the MFDS; and
• an updated version of the Medical Device Re-evaluation Guidelines (Handbook-0100-002).

Additional South Korean medical device regulatory resources from Emergo by UL:

• South Korean MFDS medical device registration consulting
• Korea Good Manufacturing Practice (KGMP) quality system support
• Whitepaper: Medical device registration in South Korea
• Regulatory process chart: MFDS approval for medical devices