As each year, between July 1 and September 1, 2018 manufacturers of Medical Devices emitting radiation are required to submit the Annual Report to the CDRH (Center for Devices and Radiological Health).
All manufacturers who have already submitted a Product Report are responsible for submitting the Annual Report, regardless of any indication of changes by means of the Supplemental Report.
Every Manufacturer of Medical Devices requested to submit the Annual Report will be required to submit a report covering production for the United States (the volume of products manufactured, sold or installed) from July 1 of the previous year until June 30 of the current year.
Once the Report is received, the CDRH will reassign the Accession Number, a reference to be communicated to the local Importer in order to effect the regularly place the devices emitting radiation on the US market.
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