KFDA Notification No. 2014-178 2014.10.31
The Ministry of Food and Drug Safety (MFDS) is publishing Korea medical device regulations update on a regular basis. It recently published a notice to inform that several changes would occur and is collecting opinions from the industry.
The original publication can be found here (published on Feb. 2, 2015).
Here is the summary of the publication:
- Selection of the medical devices which require submission of clinical trial data,
- evaluation of the software,
- clarification about sterility test data and increasing data requirement,
- ensure safety and effectiveness of high risk medical devices
Maintaining the regulation selecting the medical devices which require submission of clinical trial data and the exemption cases
When evaluating the technical documents, in case of the product being essentially equivalent to the already approved medical devices, the submission of the clinical trial data is exempted. However among the class 4 high risk medical devices, for the device which requires evaluation of clinical effectiveness, it is necessary to review its safety and effectiveness through its own submitted clinical test data, not the equivalent comparison
Appointing 63 items such as life support systems to be the medical devices which require submission of clinical test data, and maintain the exemption regulation for the data.
In case the medical devices have built-in software or in case of standalone software, the approval evaluation requires more clarified and simplified performance data
For medical devices with current built-in software or standalone software, the approval evaluation requires all the information that can verify the main function of the software. Therefore it is necessary to specify required information in detail or exemption documents to enhance the efficiency.
A Regulating of the template for documents and reports submitted for the evaluation and suitability verification is proposed.
Expansion of required document type for sterility test of sterilizing medical device
In case of sterilizing medical device, the suitability is determined by the sterility test data, however it is needed to ease the burden of the industry by recognizing internationally accredited verification report of sterilization.
Verification document recognition range is expanded, by recognizing internationally accredited verification report of sterilization besides the sterilization test data.
Expand the range of exempted products for the evaluation certificate of first class second-hand medical devices
In case of first class medical devices which has almost no potential risk, the requirement of evaluation certificate hinders the circulation of the second-hand device in the market.
Create a standard to exempt evaluation certificates for 1st class second-hand medical devices.
Clarification of required test items and submitted documents for appending data for Approval·Evaluation of medical devices
Among current technical document evaluation data, the evaluation items to verify performance and safety is stated already, so it is necessary to clarify about it in this announcement.
Define the test items for the data needed regarding biocompatibility , through the corresponding specifications, and also clearly define the types of data needed regarding physical and chemical characteristics of medical devices which utilize products of animal origin.
Rationalize the STED document template medical devices
When evaluating a technical document in STED template, detailed summarizing manner per data is regulated, however some of the unnecessary items may be removed, and the template should better reflect the product characteristics.
When creating a STED document, the specific template with the product characteristics is now allowed to be used through switching summary regulation of the template to information regulation, and the detailed entry items are improved by removing unnecessary entries.
Fixed and improved the operational inadequacies , such as defining same product family, maintaining description item for the shape, structure and manufacturing method on the application, adjusting the clinical performance data requirement of in vitro diagnosis medical devices to be aligned with other medical devices.