The Japanese Ministry of Health, Labor and Welfare (MHLW) recently announced the establishment of a new Good Laboratory Practice (GLP) regulation for medical device testing in Japan. The new GLP will take effect on October 1, 2003 and will regulate pre-clinical trial data collection in order to ensure high data quality. The GLP will define the duties of the applicant in conducting pre-clinical tests on medical devices. The new GLP also specifies that reports submitted as part of the application for medical device approval must coincide with the final test results and be endorsed by the appropriate person from the quality assurance department. The new GLP requires that the following be submitted for medical device applications:
- The certificate of the person in charge of endorsing the final test results, and a statement that certifies that the report is based on the final test results.
- A statement certifying that the test data was collected in accordance to the new GLP standard by the responsible supervisor or technician. Foreign data must also be certified with a statement indicating that the data collection was made in accordance with GLP standards equivalent to those of the Japanese GLP. If the clinical trials were not performed in accordance with the Japanese GLP, a statement must be submitted specifying any deviation from the Japanese GLP and its possible effects on the data obtained.
- A foreign government or public institution must certify foreign data to be submitted to the MHLW. The foreign authority must state that the data was collected in accordance with the foreign government’s GLP.
The MHLW also reserves the right to audit the test facility of companies periodically to ensure that they are in compliance with GLP.