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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 are evaluated by issuing an approval*
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Procedure
Online
Companii
National
Details
The purpose of this procedure is the submission and processing of the application for issuing an operating permit for activities in the field of medical devices. The operating permit is issued at the request of the economic operator, when the applicant does not hold an operating permit for activities in the field of medical devices, valid. The request will be accompanied by the OPIS of the documentation for the evaluation of import/distribution activity of medical devices and/or OPIS of the documentation for the evaluation of installation and/or maintenance activity of medical devices, completed using diacritics in the economic operator's section, as well as all the documents requested in the OPIS specific to the activity, in the order of the OPIS. All necessary information in the process of issuing an 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 at the address https://www.anm.ro/dispozitive-medicale/avize-de-functionare/. The evaluation of the file is conditional upon payment of the corresponding fee.
The approval of activities in the field of medical devices carried out by legal persons or authorized individuals is achieved 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 an operating permit in the field of medical devices, which is 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 that formed the basis of issuing the permit.
Operating permits issued in accordance with these current methodological norms are valid for a period of 3 years from the date of issue, if the conditions that formed the basis of the approval remain unchanged. The application for renewal of the operating permit must be submitted to ANMDMR at least 6 months before its expiration. 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 competent national authority in the field of medical devices.
*Entitled persons
Regulated professions
Required documents
Denumire
Descriere
Obligatoriu
Semnătură digitală
Tip document
Descarcă
-
1 REQUEST FOR ISSUANCE RENEWAL OF NOTICE*
Descarcă
2 DESCRIPTION DOCUMENTATION EVALUATION ACTIVITY IMPORT DISTRIBUTION MEDICAL DEVICES*
Descarcă
3 DESCRIPTION DOCUMENTATION EVALUATION OF THE ACTIVITY OF INSTALLATION AND/OR MAINTENANCE OF MEDICAL DEVICES*
Descarcă
4 INFO CATEGORIES AND GROUPS OF MEDICAL DEVICES*
Descarcă
5 LIST OE PERSONNEL*
Descarcă
6 TABLE MANUFACTURERS DM*
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 failure to resolve a request within the legal term, 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:
02 August 2022
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
Table of contents
Competent entities
Direcţia Avizare
Serviciul Registratură și Arhivă
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