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Procedure regarding the approval of activities in the field of medical devices carried out by authorized legal or natural persons, for which the applicant's competence and capability to carry out the respective activities are evaluated by issuing a temporary approval*
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The purpose of this procedure is the submission and processing of the application for the issuance of a temporary operating permit for activities in the field of medical devices. The temporary operating permit is issued at the request of the economic operator, when the applicant does not have an operating permit for activities in the field of medical devices, valid. The request will be accompanied by the LIST of documents required for the provisional authorization of the import/distribution/storage activity of medical devices, filled out using diacritics in the economic operator’s section, as well as all the documents requested in the list specific to the temporary permit, in the order of the list. All the information necessary in the process of issuing a temporary operating permit, as well as the forms for the required documents, can be downloaded from the website of the National Agency for Medicines and Medical Devices of Romania www.anm.ro at the address https://www.anm.ro/dispozitive-medicale/avize-de-functionare/. The assessment of the file is subject to payment of the related fee.
The authorization of activities in the field of medical devices carried out by legal entities or authorized individuals is materialized by the issuance by the Authorization Directorate within the General Directorate of Medical Devices of the National Agency for Medicines and Medical Devices of Romania of a temporary operating permit in the field of medical devices, which represents a document with the legal value of an individual administrative act, in favor of its holder. The operating permit will be accompanied by the Assessment Report that formed the basis for the issuance of the temporary permit.
In the event of the establishment of a state of emergency on the territory of Romania by decree of the President of Romania, to ensure the availability of absolutely necessary medical devices in that situation, ANMDMR will issue a temporary operating permit. The validity period of the temporary permit is 6 months. Temporary operating permits are identified by the initial T preceding the permit number. The temporary operating permit will be issued within a maximum of 7 days from the submission of all requested documents and confirmation of payment of the fiscal invoice.
The General Directorate of Medical Devices of the National Agency for Medicines and Medical Devices of Romania is the national competent authority in the field of medical devices.
*Entitled persons
Regulated professions
Required documents
Denumire
Descriere
Obligatoriu
Semnătură digitală
Tip document
Descarcă
-
Issued documents
Denumire
Tip document
Descarcă
-
Fees
Title
Payment method
Value
Currency
None
Deadlines
Resolution time:
7
Calendar days
Case filling duration:
30
Calendar days
Notification deadline:
14
Calendar days
Legislation
Appeal routes
Any person who considers themselves harmed in one of their rights or in a legitimate interest, by ANMDMR through an administrative act or by the failure to resolve a request within the legal term, may address the competent administrative court under the conditions established by the Administrative Litigation Law no. 554/2004.
In the case of a dispute between the beneficiary and the competent authority, the provisions of common law are applicable.
*Additional information
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Last updated:
17 February 2021
Publicat de către:
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Institution responsible with document:
Publicat de către:
A paragraph is a self-contained unit of a discourse in writing dealing with
a particular point or idea. Paragraphs are usually an expected part of
formal writing, used to organize longer prose.
National Agency for Medicines and Medical Devices of Romania*
*Content marked with an asterisk (*) has been automatically translated and may not fully reflect the original meaning. For objective interpretation, please consult the Romanian version.
Str. Aviator Sănătescu 48
Telefon:
+40213171100
Fax:
+40213163497
Email:
secretariat@anm.ro
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Competent entities
Direcţia Avizare
Serviciul Registratură și Arhivă
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