Report of the OTO Advisory Council (April 12, 1993)

1-(6) Simplifying process of obtaining examination certificates for imports of medical equipment samples

1. Complainant: Keidanren

2. Ministry concerned: Ministry of Health and Welfare

3. Complaint:

Regarding imports of pharmaceuticals for testing and research purposes which have not been approved under the Pharmaceutical Affairs Law, the importer must undergo prior examination by a pharmaceuticals examiner and obtain an examination certificate which is required for customs clearance.

Documents needed to obtain an examination certificate are an import report form, a testing program certificate, an affidavit certifying that the articles have not been imported to sell or give away, and an invoice. If an importer orders multiple units and these are imported in a number of shipment, in connection with the invoice and air waybill.

The complainant states that in the case of medical equipment, it is common for shipment to be divided even when only one order for samples was placed; It is very inconvenient to have to obtain an examination certificate each time and the procedure should be simplified.

4. Results of deliberation:

The purpose of the examination certificate is to determine the appropriateness of the types, amount, and purpose of medicines not approved under the Pharmaceutical Affairs Law being imported. In cases like those described in the complaint, where identical products are imported in more than one shipment, office procedures could be amended to make it possible to verify the appropriateness of the imports expected in the initial application. Accordingly, these procedures should be reviewed.

In the light of this complaint, the ministry or agency concerned is currently examining the situation in order to change procedures for obtaining examination certificates, and this is expected to settle the matter.

Government decision (May 27, 1993)

The process of obtaining examination certificates for imports of medical equipment samples will be simplified.