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Procedure regarding the approval of activities in the field of medical devices carried out by authorized legal or natural persons who hold a valid operating approval and who wish to modify it by issuing an annex to the held operating approval*
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Procedure
Online
Companii
National
The purpose of this procedure is the submission and processing of the request for amending the operating authorization held by the economic operator for activities in the field of medical devices. The annex to the held 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, valid, and wishes to amend it by expanding or restricting the field of activity. The request will be accompanied by the LIST of documents for evaluation of import/distribution activity of medical devices and/or the LIST of documents for evaluation of installation and/or maintenance activity of medical devices, completed using diacritics in the economic operator's section, as well as all documents requested in the LIST specific to the activity, in the order of the LIST, in case the extension of the field of activity is requested by adding a work point with activity in the field of medical devices or by adding activity to an address already in the held authorization. If the change of the registered office address is requested, an office where activities in the field of medical devices are carried out, it will be treated as the addition of a work point. For all other amendments provided in the request for amending the operating authorization (Annex 2 to the current methodological norms in force), the documents provided in the application shall be attached as well as all documents requested by the inspector responsible for the file. All necessary information for the process of issuing an annex to the held 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 at www.anm.ro at the address https://www.anm.ro/dispozitive-medicale/avize-de-functionare/. File evaluation is conditioned by payment of the corresponding fee.
The authorization of new activities or new locations where activities are carried out in the field of medical devices by legal entities or authorized natural persons is materialized 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 annex to the operating authorization held in the field of medical devices, which represents a document with legal value as an administrative act of individual character, in favor of its holder. The annex to the operating authorization is valid only accompanied by the initial authorization, for the duration of the validity of the authorization. The annex to the operating authorization will be accompanied by the Evaluation Report which formed the basis for issuing the annex only if one or more work points with activity in the field of medical devices are added, or if one or more activities are added to one or more addresses already in the held authorization.
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 REQUEST TO MODIFY OPERATING NOTICE*
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 DOCUMENTATION EVALUATION 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 OE STAFF*
Descarcă
Formular tipizat
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
6 TABLE MANUFACTURERS DM*
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
Other documents (the decision of the ANMDMR president for temporary suspension or cessation of activity, the decision of the ANMDMR president for file closure, file closure letter at the request of the economic operator, unfavorable evaluation report)*
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:
42
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.
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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