The Ministry of Food and Drug Satefy of Korea (the "MFDS") announced major policy initiatives in the medical device sector (among others) for 2017 on January 9, 2017 (the "Policy Initiative"). With respect to the medical device sector, the MFDS declared plans to select the "Enhancement of the Safety Management System" as its main priority, and thereby strengthen user-centered safety management as well as to offer support in bolstering global competitiveness.
Further, the MFDS published the "Prospect Analysis Report of Novel Medical Devices" which applies new technologies (the "Report") on February 2, 2017. Based on the Report, the MFDS intends to support a proactive industry response by discussing the current status of technological developments and trends of novel medical devices stemming from the Fourth Industrial Revolution, which use big data and artificial intelligence (AI) technology (i.e. smart medical devices).
An introductory overview of the Policy Initiative for medical devices among the MFDS' major policy initiatives and the details of the Report are as follows.
1. Policy Initiative
(1) Improved Recall System for Non-Conforming Medical Devices
Introduced Sales Prevention System for Hazardous Medical Devices
Under the Policy Initiative, a slaes prevention system for hazardous medical devices will be introduced in order to create a conducive environment for the use of distributed medical devices by consumers. As a means to prepare the basis for the prompt recall of products that are exempt from the sales business report requirement, such as digital thermometers and pregnancy test devices, the MFDS plans to newly introduce a "sales prevention system for hazardous medical devices" to large retailers handling personal/household medical devices and mail-order vendors from March 2017.
Expanded Scope of Hazardous Medical Devices to be Recalled
In October 2017, the MFDS will proceed to amend the Medical Devices Act of Korea (the "MDA") to expand the scope of the to-be-recalled hazardous medical devices. The current MDA prescribes that the to-be-recalled hazardous medical devices are those that "pose the risk of causing serious harm to or fatal impact on public health". However, the MFDS plans to expand the scope of such medical devices by amending this provision to those that "cause harm or risk causing harm to the public health".
(2) Established Integrated Information Systems of Medical Devices
Under the Policy Initiative, the MFDS will proceed to establish an integrated information system, which collects and manages a medical device's lifecycle information by personally identifiable codes (the "Medical Device ISS") in order to fulfill the safety management of patients through the background traceability management, which is based on the medical device's lifecycle, i.e., from the manufacturing to the distribution/use of the medical device. In addition to establishing the systematic/policy basis for the Medical Device ISS under the MDA, which was amended and promulgated on December 2, 2016, the MFDS intends to concretize the implementation plan within 2017 and execute such plan in stages from 2018.
Under the amendment of the MDA, the Product Standard Code of a medical device shall be listed on the container or wrapper thereof, in case a medical device vendor/renter, the supplying entity shall report the supply details to the MFDS. Further, the MFDS shall establish and operate the Medical Device IIS and medical device manufacturers (among others) shall register the Product Standard Code and details of the medical device under the Medical Device IIS.
2. Report Details
The Report mainly consists of the market size, development status and trends (among others) of 3D printing medical devices, robotic medical devices and biomaterial medical devices respectively. These medical devices are briefly introduced below.
3D Printing Medical Devices
The Report forecasts that the market in Korea for 3D printing medical devices will grow by an annual average of 29.1% and reach KRW 40 billion (approximately equivalent to USD 37 million) in 2021.
3D printing medical devices currently in developed in Korea or abroad include dental medical devices, such as orthodontic retainers and dental implants, and implantable medical devices, such as artificial bones and joints. Further, 3D printing medical devices which were approved or reported in Korea include cranioplasty plates, spinal cages (or intervertebral body fusion devices) and guides for medical devices.
ICT-based Medical Devices
The Report forecasts that the Korean market for ICT-based medical devices will increase up to KRW 14 trillion (approximately equivalent to USD 12 billion) in 2020.
In Korea and abroad, ICT-based medical devices, including mobile apps for monitoring blood sugar levels and contact lens tonometers, are being developed. Further, U-healthcare gateways and U-healthcare blood glucose monitoring devices were approved and reported in Korea.
Robotic Medical Devices
The Report forecasts that the current market in Korea for robotic medical devices is dramatically growing by an annual average of 45.1% and is expected to reach KRW 56.6. billion (approximately equivalent to USD 49 million) in 2018. According to the Report, surgical robots used for teleconsulting are known to be subject to research and development. Further, robotic medical devices that were approved in Korea include automated robotic surgical system and robot-guided rehabilitation system.
Biomaterial Medical Devices
Biomaterial medical devices constitute an extremely diverse category of items. They refer to medical where biomaterials that are degradable and absorbable in the human body are inserted into such medical devices. Biomaterial medical devices that were approved in Korea include coronary stents.