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The 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 perform these activities are assessed, by issuing a renewed approval.*
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Procedure
Online
Companii
National
Details
The purpose of this procedure is the submission and processing of the request for issuing a renewed operating permit for activities in the field of medical devices. The renewed operating permit is issued at the request of the economic operator, when the applicant holds an operating permit for activities in the field of medical devices, which is within the renewal period, valid. The request will be accompanied by the OPIS of the documentation for evaluating the import/distribution activity of medical devices and/or the OPIS of the documentation for evaluating the installation and/or maintenance activity of medical devices, completed using diacritics in the economic operator's field, as well as all documents requested in the OPIS specific to the activity, in the order of the OPIS. All information necessary for the process of issuing a renewed operating permit, as well as the 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 from the address https://www.anm.ro/dispozitive-medicale/avize-de-functionare/. The evaluation of the file is subject to payment of the corresponding fee.
The authorization of activities in the field of medical devices carried out by legal persons or authorized individuals is materialized through 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 renewed operating permit in the field of medical devices, which represents a document with legal value of an administrative act with individual character, in favor of its holder. The renewed operating permit will be accompanied by the Evaluation Report that formed the basis for the issuance of the renewed permit.
Renewed operating permits issued in accordance with these applicable methodological regulations are valid for a period of 3 years from the date of issuance, provided that the conditions on which the authorization was based remain unchanged. The application for renewing the operating permit must be submitted to ANMDMR at least 6 months before the expiry of its validity. Otherwise, the authorization procedure will be resumed.
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 APPLICATION FOR ISSUANCE RENEWAL OF NOTICE*
Descarcă
2 DESCRIPTION DOCUMENTATION ASSESSMENT ACTIVITY IMPORT DISTRIBUTION MEDICAL DEVICES*
Descarcă
3 DESCRIPTION DOCUMENTATION EVALUATION ACTIVITY OF INSTALLATION AND/OR MAINTENANCE OF MEDICAL DEVICES*
Descarcă
4 INFO CATEGORIES AND GROUPS MEDICAL DEVICES*
Descarcă
5 LIST OF OWN PERSONNEL*
Descarcă
6 DM MANUFACTURERS TABLE*
Descarcă
Issued documents
Denumire
Tip document
Descarcă
-
Fees
Title
Payment method
Value
Currency
None
Deadlines
Resolution time:
120
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 a legitimate interest by ANMDMR through an administrative act or by failing 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 common law provisions are applicable.
*Additional information
More info:
Links
Assistance and problem-solving services
None
Last updated:
02 August 2022
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.
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
Table of contents
Competent entities
Direcţia Avizare
Serviciul Registratură și Arhivă
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