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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 an approval*
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Procedure
Online
Companii
National
The purpose of this procedure is the transmission and processing of the application for the issuance of 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 INDEX of the documentation for the evaluation of import/distribution activity for medical devices and/or the INDEX of the documentation for the evaluation of the activity of installation and/or maintenance of medical devices, completed using diacritics in the economic operator’s section, as well as all documents requested in the index specific to the activity, in the order of the index. All the information necessary for 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 at 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 entities or authorized natural persons materializes by issuing, by the Authorization Directorate within the General Directorate for Medical Devices of the National Agency for Medicines and Medical Devices of Romania, an operating permit in the field of medical devices, which represents a document with the legal value of an administrative act with an individual character, in favor of its holder. The operating permit will be accompanied by the Evaluation Report that formed the basis for the issuance of 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 for authorization remain unchanged. The application for renewal of the operating permit must be submitted to the 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 ISSUANCE RENEWAL OF NOTICE*
Descarcă
Formular tipizat
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
2 DESCRIPTION DOCUMENTATION EVALUATION ACTIVITY OF IMPORT DISTRIBUTION MEDICAL DEVICES*
Descarcă
Formular tipizat
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
3 DESCRIPTION OF DOCUMENTATION ASSESSMENT OF INSTALLATION AND/OR MAINTENANCE ACTIVITY FOR 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 STAFF O.E.*
Descarcă
Formular tipizat
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
6 TABLE DM PRODUCERS*
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 a right or a legitimate interest, by the ANMDMR through an administrative act or by the failure to resolve a request within the legal term, may address the competent administrative litigation court under the conditions established by the Law on Administrative Litigation 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
Table of contents
Competent entities
Direcţia Avizare
Serviciul Registratură și Arhivă
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