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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 a renewed approval*
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Procedure
Online
Companii
National
The purpose of this procedure is the submission and processing of the request for issuing a renewed operating authorization for activities in the field of medical devices. The renewed operating authorization is issued at the request of the economic operator, when the applicant holds an operating authorization for activities in the field of medical devices, within the renewal period, valid. The request will be accompanied by the INDEX of documents evaluating the activity of import/distribution of medical devices and/or the INDEX of documents evaluating the activity of installation and/or maintenance of medical devices, filled in using diacritics in the section for the economic operator, as well as all documents requested in the index specific to the activity, in the order of the index. All necessary information in the process of issuing a renewed operating authorization, 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 upon payment of the corresponding fee.
The authorization of activities in the field of medical devices carried out by legal entities or authorized natural persons is materialized by the issuance by the Authorization Department within the General Department of Medical Devices of the National Agency for Medicines and Medical Devices of Romania of a renewed operating authorization. in the field of medical devices representing a document with legal value as an administrative individual act, in favor of its holder. The renewed operating authorization will be accompanied by the Evaluation Report that formed the basis for the issuance of the renewed authorization.
The renewed operating authorizations issued in accordance with these current methodological norms are valid for a period of 3 years from the date of issuance, if the conditions that formed the basis of the authorization remain unchanged. The request for renewal of the operating authorization must be submitted to ANMDMR at least 6 months before its expiry date. Otherwise, the authorization procedure will restart.
The General Department 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 ISSUANCE/RENEWAL OF APPROVAL*
Descarcă
Formular tipizat
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
2 DESCRIPTION OF DOCUMENTATION EVALUATION ACTIVITY FOR IMPORT DISTRIBUTION OF MEDICAL DEVICES*
Descarcă
Formular tipizat
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
3 DESCRIPTION DOCUMENTATION EVALUATION ACTIVITY OF INSTALLATION AND/OR MAINTENANCE 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 PERSONAL OE LIST*
Descarcă
Formular tipizat
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
6 DM MANUFACTURERS TABLE*
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 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.
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
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Competent entities
Direcţia Avizare
Serviciul Registratură și Arhivă
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