Clinical Data Evaluation for Foreign Medical Device Companies Seeking Japanese PMDA Approval

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If you plan to register a “new to market” or "high risk" medical device in Japan with few predicate devices, clinical trials may be required for your medical device.

In Japan, the MHLW enforces Ordinance No. 36, "GCP Regulation," concerning the Standards for Executing Clinical Tests on Medical Devices. Furthermore, in August, 2008, a notice was issued regarding "Necessary Scope of Clinical Investigation Data on Medical Devices." It is based on GHTF SG5 N2-R08 "Clinical Evaluation."

The main contents of this new notice are as follows:

When the clinical efficacy and safety of a medical device cannot be evaluated based only upon the results of non-clinical investigations such as performance tests and animal tests, or existing literature, etc., a clinical study must be conducted and technical documents on the results of the clinical investigation must be submitted.
Whether the technical documents on clinical investigation records are necessary will be determined on a number of factors including the characteristics of the particular medical device, equivalency with an existing medical device, and non-clinical investigation results. Therefore, if necessary, use the clinical evaluation consultation or pre-application consultation service offered by the Pharmaceuticals and Medical Devices Agency (PMDA) to determine whether such technical documents are necessary.

Most of the time, the PMDA accepts the results of clinical trials conducted outside of Japan if such investigation conforms to the equivalent standard in Japan's GCP Regulation. To determine acceptability of the foreign clinical data, we can assist you in scheduling a pre-consultation meeting for clinical evaluation with the PMDA. At that time the PMDA may require additional clinical investigations to be conducted in Japan. If the PMDA requires additional clinical investigations to be conducted, Emergo Japan can assist you with contracts, protocol preparation, GCP documentation, clinical investigation document review and more.