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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 permit and who wish to modify it by issuing an annex to the held operating permit*
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Procedure
Online
Companii
National
The purpose of this procedure is the submission and processing of the application for the modification of the operation permit held by the economic operator for activities in the field of medical devices. The annex to the operation permit held is issued at the request of the economic operator, when the applicant holds a valid operation permit for activities in the field of medical devices and wishes to modify it by extending or restricting the scope of activity. The request will be accompanied by the INDEX of documents for activity evaluation for import/distribution of medical devices and/or the INDEX of documents for activity evaluation for installation and/or maintenance of medical devices, completed using diacritics in the economic operator’s section, as well as all the documents requested in the index specific to the activity, in the order of the index, in case the extension of the scope of activity is requested by adding a work location with activity in the field of medical devices or by weathering an activity at an address already existing in the held permit. 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 location. For all other modifications provided for in the request for modification of the operation permit (annex 2 to these current methodological norms), the documents provided for in the request as well as all documents requested by the inspector responsible for the file must be attached. All information necessary in the process of issuing an annex to the held operation 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 assessment of the file is subject to payment of the related fee.
Approval of new activities or new locations where activities in the field of medical devices are performed by legal or authorized natural persons is materialized by issuing, by the Approval Directorate within the General Directorate for Medical Devices of the National Agency for Medicines and Medical Devices of Romania, an annex to the operation permit held in the field of medical devices, which represents a written document with the legal value of an individual administrative act, in favor of its holder. The annex to the operation permit is valid only with the initial permit, for the duration of the permit's validity. The annex to the operation permit will be accompanied by the Evaluation Report which formed the basis for issuing the annex only in the case where one or more work locations with activity in the field of medical devices are added or one or more activities are added at one or more addresses already existing in the held permit.
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 CHANGE OF OPERATING PERMIT*
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 DOCUMENTATION EVALUATION ACTIVITY OF INSTALLATION AND/OR MAINTENANCE 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 PERSONAL LIST OE*
Descarcă
Formular tipizat
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
6 TABLE 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
Other documents (the decision of the ANMDMR president for temporary suspension or termination of activity, the decision of the ANMDMR president to close the file, letter of file closure 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 a right or in a legitimate interest by ANMDMR through an administrative act or through 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:
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.
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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