A notice is given for Limited Revision regarding Medical Device Act 1081; released May 9, 2014 of the South Korea medical device regulations as below:
1. Reasons for Revision
A. Subcontracting
B. In-Vitro Diagnostic
C.License Modification exemption
D.Distribution Quality Management Standard
E.Periodic Reporting
F. Recall Notification
The pharmaceutical drugs and the medical devices are currently divided and managed separately. By consolidating the management system regarding vitro diagnostic products into a unified channel, it can prevent confusion within the related industries, and promote consumer convenience when purchasing vitro diagnostic products. Moreover, it is sought to implement and balance certain operational deficiencies in the current system as such that the manufacturers and importers of medical device need not submit the license in the future when requesting the modification of license, as well as the removal of limitations on the extent of subcontracting medical device manufacturing process.
2. Key Details
A. Subcontracting
Lifting limitation on the extent of subcontracting medical device manufacturing process (Proposed Section 5, Article 1.2 and Appendix 2, Article 1.3)
Limitation on the extent of subcontracting medical device manufacturing process is lifted. The subcontracting company is to provide the subcontractor with the manual of product specifications (such as the Device Master Record or DMR) for the product quality control, and the subcontractor is to record the details of manufacturing and product quality control based on the manual. It is to define the management responsibility of the manufacturer that subcontracts the manufacturing process and the subcontractor.
B. In-Vitro Diagnostic
Unifying the management system of vitro diagnostic products (Proposed Section 7, Article 3; Section 12, Article1.3; Appendix 1.1.C and Addendum Section 6)
In-Vitro diagnostic products that are currently managed as pharmaceutical products under 「Pharmaceutical Act」 may be managed along with vitro diagnostic reagents as vitro diagnostic medical device, and the name of vitro diagnostic reagents is to be reclassified as vitro diagnostic medical device.
C.License Modification exemption
Extending the extent of exemption for medical device importing license (Proposed Section 19.2, Article 1)
1) When performing clinical tests of medical devices, it is necessary to use separate medical devices in order to verify the conditions of the clinical test subjects as well as the use of medical devices that are subject to the clinical tests and the medical devices themselves. Nonetheless, if the clinical tests of said medical devices prove to be impossible because of the difficulties stemming from importing license of said medical devices, then they may be exempted from obtaining importing license.
2) When importing medical devices for the purpose of research, such as the development of medical device, consideration may be given to allow importing medical devices for testing without importing license. Accordingly, the legal authority is to be clarified.
D.Distribution Quality Management Standard
Adopting of distribution quality management standards for medical devices (Proposed Section 25, Article 1; Proposed Appendix 6.2 newly established)
The distribution quality management standards such as the standard of facilities and equipment that manufacturers or leasing agents are required of, are to be established, The manufactures or leasing agents are to be required of adhering those standards.
E.Periodic Reporting
Establishing periodic reporting of medical devices subject to tracking, as well as standardizing codes (Proposed Section 31, Article 2; Proposed Section 31, Article 5 newly established)
Manufacturers/importers/distributors/leasing agents and repairing agents of the medical devices subject to tracking are to be required of submitting records and data monthly regarding medical devices subject to tracking. The Minister of Food and Drug Safety is to establish and operate standardized codes that can be attached or recorded to the container or external packaging of the medical device subject to tracking.
F. Recall Notification
Notifying recall fact of medical devices subject to recall by the establisher of medical facility (Proposed Section 32.3, Article 5 newly established)
The establisher of medical facility is to be required of notifying the patients regarding the medical device that is being used for their treatment when the said medical device is subject to recall for the reasons that the use of such medical device may cause an irreparable side effects or lead to death.
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