When a letter of exemption is required
The letter of exemption signed by the Ministry of Healthcare serves as to justify that registration is not required for a specific medical product whenever there is disagreement on the issue. For instance, the customs agencies and trade regulators can demand such a document.
Who issues the letter of exemption
In Russia, the letter of exemption should be issued by a special accredited body authorized to certify goods for their sale on the Russian territory. The letter of exemption is an official response to the regulator demanding this document in order to allow the sale of a product. The letter of exemption is issued in the name of one legal entity.
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