MISR TECHNOLOGY FOR BIOLOGICAL INDUSTRIES
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Responsibilities and obligations of the distributor
Terms of Conditions
Responsibilities and Obligations of The Distributor
The distributor must store and transport the medical diagnostic kits according to the manufacturer’s specifications. The distributor must always accompany the diagnostic kit any related quality documentation if instructed by the manufacturer. In case the distributor is involved in translating the package insert and label, the distributor should follow the manufacturer’s translation procedure. In particular, translation should be reviewed by a professional third party translator who should issue a statement of correctness.
Time Limitation for Reporting
Incidents should be reported without delay in accordance with the required urgency of attention but in any case within a maximum of 3 days from the Incident. If a delay is likely to cause danger, the notification shall be made immediately.