On Feb. 9, 2015, the Korean Ministry of Food and Drug Safety (the “Ministry”) announced its plan to reform regulations governing mobile health products in light of the rapid growth of this emerging sector. In furtherance of this plan, the Ministry will commission policy research on classifying and regulating mobile medical devices according to the purpose of use, i.e., medical versus non-medical. Depending on the research results, the Ministry will determine whether to amend relevant regulations and to propose amendments to relevant statutes.
The policy research is not the Ministry’s first attempt at reform in the mobile health and medical devices sector. On Dec. 31, 2013, the Ministry issued Guidelines on Safety Management of Mobile Medical Apps. These guidelines provide guidance on whether medical apps on mobile devices such as smart phones are classified as medical devices. Further, on Aug. 18, 2014, the Ministry amended the Regulations on Approval, Declaration, and Review of Medical Devices. Through the amendment, the Ministry granted sellers of selfdiagnosis apps as well as mobile devices containing such apps an exemption from the filing required to sell medical devices. These prior efforts at reform, however, implemented change only at the downstream level of administrative regulations rather than at the upstream level of statutes that established the underlying principles governing the mobile health and medical devices sector. As such, these prior efforts at reform failed to adequately reflect the technological trends and demands of the sector.
The policy research commissioned by the Ministry focuses on three key topics: (i) technological trends of mobile medical devices and changes in their service environment, (ii) relevant statutory provisions of the eight member countries of the International Medical Device Regulatory Forum (IMDRF), including definitions, classification criteria, regulatory means, and current status of medical devices, and (iii) proposals on reasonable regulation of products with a non-medical purpose under the Korean medical device statute. The policy research is expected to be completed by the first half of 2015. Once the policy research is completed, the Ministry expects to devise concrete reform measures within 2015 after a public hearing at which it will solicit comments from experts and interested parties.