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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 renewed approval.*
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Procedure
Online
Companii
National
The purpose of this procedure is to transmit and process the request for the issuance of 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, within the renewal period, valid. The request shall be accompanied by the OPIS for evaluating the import/distribution activity of medical devices and/or OPIS for evaluating the installation and/or maintenance activity of medical devices, completed using diacritics in the economic operator's section, as well as all documents required in the OPIS specific to the activity, in the order of the OPIS. All the necessary information 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 at www.anm.ro at the address https://www.anm.ro/dispozitive-medicale/avize-de-functionare/. The evaluation of the file is conditional on payment of the corresponding 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 Department within the General Directorate for 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 constitutes a document with the 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 which constituted the basis for issuing the renewed permit.
Renewed 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 for authorization remain unchanged. The request for renewal of the operating permit must be submitted to ANMDMR at least 6 months before its validity expires. Otherwise, the authorization procedure will be resumed.
The General Directorate for 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 RELEASE RENEWAL OF AUTHORIZATION*
Descarcă
Formular tipizat
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
2 OPIS DOCUMENTATION EVALUATION OF ACTIVITY IMPORT DISTRIBUTION MEDICAL DEVICES*
Descarcă
Formular tipizat
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
3 DESCRIPTION OF DOCUMENTATION EVALUATION OF INSTALLATION AND/OR MAINTENANCE ACTIVITY OF MEDICAL DEVICES*
Descarcă
Formular tipizat
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
4 INFO CATEGORIES AND GROUPS OF MEDICAL DEVICES*
Descarcă
Formular tipizat
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
5 LIST OF OE STAFF*
Descarcă
Formular tipizat
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
6 TABLE OF DM MANUFACTURERS*
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:
120
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 failure to resolve a request within the legal timeframe, 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
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.
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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