Sep 28, 2020
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.
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:
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.”
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:
A revision to the law governing medical devices states that marketing authorizations now last for five years rather than indefinitely.
The Ministry of Food and Drug Safety (MFDS) published the regulatory changes after a period of public consultation.
The South Korean Ministry of Food and Drug Safety (MFDS) has moved to reduce registration submiss
New regulation will set specific registration requirements for IVD devices