Provisional Translation

OTO No. 434 Classification MHW-209
Date of Acceptance December 4, 1990 Ministry/Agency Receiving Complaint Economic Planning Agency
Responsible Ministries Ministry of Health and Welfare Related Laws The Pharmaceutical Affairs Law
Complainant Domestic firm Exporting Countries Denmark
Subject Clarification of the period required for obtaining approval for medical equipment and for the simplification and acceleration of this process.
Details of Measures In this particular case, the applicant applied for approval import and sell medical equipment and for import approval for the specific equipment at the same time.
Generally, the time required to process an application for approval for medical equipment is four months, but efforts are made in such cases as this one to complete the processing in about three months.
The complainant was under the mistaken impression that such processing routinely takes four months, but it was explained that the processing was completed in slightly less than three months.
Classification of Processing Ca Directions I-b
II-a
Remarks

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