[비즈한국] A leading domestic testing organization that conducts non-clinical trials for medical devices has been caught performing tests after changing conditions based on a client’s request without any scientific justification. The incident is expected to cause a significant stir regarding the reliability of non-clinical trial data and the independence of testing institutions.
The Ministry of Food and Drug Safety (MFDS) issued a warning on the 28th of last month to the Bio-Chemical Division of the Korea Conformity Laboratories (KCL), a designated non-clinical medical device testing institution, for violating the Enforcement Rules of the Medical Device Act and Good Laboratory Practice (GLP) standards.
According to the administrative action, it was confirmed that KCL conducted tests on medical devices intended for export and issued final reports by applying elution conditions requested by the client, deviating from the test guidelines that form the basis of the non-clinical trial protocol, without providing any separate theoretical justification.
The MFDS deemed this a violation of GLP and issued a warning. As a warning is the lowest level of administrative action, it does not carry legal consequences such as the revocation of KCL’s GLP designation or the suspension of its testing operations, allowing the institution to continue its normal operations and issuance of test reports.
Nevertheless, the assessment is that this action is not trivial, as it rings an alarm regarding the objectivity and independence that a GLP-certified institution must maintain when setting and modifying test conditions, extending beyond mere procedural negligence.
KCL, the organization caught in this incident, is a prominent agency under the Korean Agency for Technology and Standards of the Ministry of Trade, Industry and Energy, and is the largest comprehensive testing and certification body in the country. It conducts testing, inspection, and certification across the entire industrial spectrum, including construction materials, environment, household goods, and chemicals, in addition to medical devices.
In particular, the KCL Bio-Chemical Division serves as a medical device GLP-certified institution designated by the MFDS, specializing in biological safety evaluations such as cytotoxicity, genotoxicity, and implantation tests, as well as chemical characterization tests. The division conducts hundreds of medical device biological safety and GLP tests annually, producing data used by domestic medical device companies for domestic MFDS approvals as well as international certifications like FDA and CE MDR.
Since GLP institutions play a role in objectively verifying the safety of medical devices, test data is used not only for MFDS reviews but also for submission to overseas regulatory agencies, making the objectivity and reproducibility of results paramount.
GLP is a system designed to ensure the reliability of test data by standardizing the entire process from test execution to protocol preparation, modification of test methods, and reporting of results. When changing test conditions, the scientific basis and reasons for the change must be clearly recorded and verified; test methods must not be altered simply at the request of a client.
Industry experts view this disciplinary action not as a case questioning the safety of the medical devices themselves, but as a reminder of the importance of maintaining the independence of testing institutions and ensuring data integrity. Specifically, they note that because medical device companies use GLP test data for domestic and international approvals, the objectivity of the testing institution is directly linked to the reliability of the entire industry.
A source in the medical device industry pointed out, "Since test reports must be issued in accordance with established standards to be valid, this is not a common occurrence in the industry. While it is possible that a company requested special conditions to meet specific requirements from an export destination, such as overseas approvals, accepting those requests and issuing a report without scientific evidence or reference to relevant standards could lead to misuse or abuse."
The names of the companies that requested the tests, the specific medical devices involved, and whether the test data were actually used for regulatory approvals were not disclosed in this administrative action. A KCL official stated, "Information regarding the client and the product is subject to confidentiality obligations under our contracts, making it difficult for the research institute to disclose it at its own discretion."