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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 competence and capability of the applicant to carry out the respective activities is evaluated by issuing a temporary approval.*
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Procedure
Online
Companii
National
The purpose of this procedure is the submission and processing of the request 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 a valid operating permit for activities in the field of medical devices, valid. The request will be accompanied by the OPIS Required documents for temporary authorization of activity for import/distribution/storage of medical devices, filled in using diacritics in the economic operator's section, as well as all documents requested in the specific opis for the temporary permit, in the order of the opis. All the information required in the process of issuing a temporary operating permit, as well as forms for the requested 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 evaluation of the file is conditioned by the payment of the corresponding fee.
The authorization of activities in the field of medical devices carried out by legal persons or authorized natural persons 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 legal value as an individual administrative act, in favor of its holder. The operating permit will be accompanied by the Evaluation Report which was the basis for issuing 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, the 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 which precedes 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 the payment of the tax 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
-
1 REQUEST FOR TEMPORARY AUTHORIZATION ISSUANCE*
Descarcă
Formular tipizat
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
2_ DESCRIPTION OF DOCUMENTS REQUIRED FOR TEMPORARY APPROVAL OF THE ACTIVITY OF IMPORT DISTRIBUTION STORAGE OF MEDICAL DEVICES*
Descarcă
Formular tipizat
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
3 OE PERSONAL LIST*
Descarcă
Formular tipizat
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
4 PRODUCERS TABLE DM*
Descarcă
Formular tipizat
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Issued documents
Denumire
Tip document
Descarcă
-
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
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 a right or legitimate interest, by ANMDMR through an administrative act or by failure to resolve a request within the legal deadline, may address the competent administrative litigation 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
More info:
Links
Assistance and problem-solving services
None
Last updated:
17 February 2021
Publicat de către:
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a particular point or idea. Paragraphs are usually an expected part of
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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.
The 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.
The National Agency for Medicines and Medical Devices of Romania*
Str. Aviator Sănătescu 48
Telefon:
+40213171100
Fax:
+40213163497
Email:
secretariat@anm.ro
Table of contents
Competent entities
Direcţia Avizare
Serviciul Registratură și Arhivă
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