In accordance with Article 2 of the on approval of the Methodological rules for application of Title XX of Law 95/2006 on healthcare reform, regarding the approval of activities in the field of medical devices (MD), approved through Order of the Minister of Health no. 566/2020 (hereinafter referred to as the Rules), the activities related to marketing and service provision in the field of medical devices subject to approval control are:
a) import of medical devices;
b) distribution of medical devices;
c) installation and/or maintenance of medical devices.
download Order of the Minister of Health no. 566/2020 
Explanations regarding the payment of tariffs for evaluation of files for the activities subject to control through approval
In accordance with Order No. 3467 of 17 November 2022 on approval of the tariffs for the activities carried out by the National Agency for Medicines and Medical Devices of Romania (NAMMDR) in the field of medical devices, issued by the Ministry of Health, published in the Official Gazette, Part I, no. 1123 of 22 November 2022, the tariffs applied for issuance, renewal and/or modification of the operation permit for import/distribution/installation and maintenance activities are collected based on the invoice sent to the economic operator, after the application was submitted. As provided by Article 10 (1) of Order no. 566/2020, the invoice will be issued within a maximum of 90 days from the date of submission of the application. Failure to pay the tax invoice within the term mentioned on it leads to the filing of the file.
Order no. 3467 of 17 November 2022 on approval of the tariffs for the activities carried out by the National Agency for Medicines and Medical Devices of Romania (NAMMDR)
download Order of the Minister of Health no. 3467/2022
In this section, the National Agency for Medicines and Medical Devices of Romania (NAMMDR) provides, in editable format, all the documents required to be completed by economic operators (EOs), in line with the requirements of Article 5, paragraphs 1-4 of the Rules, so that the documentation submitted to the file is complete. You can also find clarifications regarding the approval of certain activities or the drafting of certain documents.
I. Clarifications concerning the submission of files for evaluation of activities subject to approval control
The documentation required for the issuance, renewal or modification of the OPERATION PERMIT must comply with the following requirements:
> to be preceded by the application form in Annex 1 (for issuance or renewal of the operation permit) or by the application form in Annex 5 (for modifying the operation permit), as the case may be;
> to contain all the documents required in line with the specifics of the request, with signature, date, registration number or certification “in accordance with the original“, as the case may be;
> to be entered in the List for assessment documentation of the approved activity (Annex 2, Annex 3 or Annex 6), in the column intended for economic operators (EOs), as appropriate;
> to contain complete documents, specified in the List, without missing pages, in A4 format, legible.
As regards the approval of several activities or several work points, a single file shall be submitted, so that the common documents specific to each approved activity are submitted only once.
The manufacturers of the medical devices to be sold by the economic operator shall be listed alphabetically in the Manufacturers Table (Form F6) with the exact name according to the declaration of compliance.
A single declaration of compliance shall be submitted for each manufacturer and, depending on the risk class of the medical device resulting from the declaration of compliance, the certificate of compliance corresponding to the medical devices that are the subject of the declaration of compliance.
Annexes 2, 3 and 6 and Forms 6 and 7, as the case may be, shall be submitted to the file in editable format (Word or Excel), on digital media (USB memory stick).
NOTE: As a result of the evaluation of the submitted documentation, there is a possibility that certain documents may be non-compliant or missing, in this regard the economic operator receives applications requesting additions. After two revaluations as a result of non-tariff addition requests, any new revaluation imposes a new tariff consisting of 50% of the initial tariff.
II. Annexes and forms needed for the preparation of the documentation regarding the issuance, renewal or modification of the operation permit
a) Annexes to Order no. 566/2020:
| Application for release / renewal of the operation permit – Annex 1 download document  |
| Application for modification of the operation permit – Annex 5 download document |
| List of the documents for evaluation of the import/distribution activity – Annex 2 download document |
| List of the documents for evaluation of the installation and/or maintenance – Annex 3 download document |
| List of the documents required for the temporary approval of the activity of import/distribution of medical devices – Annex 6 download document |
b) Forms used for completion of the documentation:
| Table with the manufacturers of imported or distributed medical devices – Form 6 download document |
| Categories and groups of medical devices for which approval of the installation and/or maintenance activity is required (according to technical training diplomas held, technical checklists specific to medical devices in the portfolio and to measuring and monitoring equipment (EMMs) available for installation, maintenance or fixing of the medical devices) – Form 7 download document |
| List of the economic operator staff – Form 8 download document |
| Decision to appoint the person responsible for regulatory compliance (PRCR) and/or the warehouse manager – Form 9 download document |
| List of measuring and monitoring tools and equipment – Form 10 download document |
| Technical inspection bulletin (template) – Form 11 download document |
| Categories and groups of medical devices (informative) – Form 12 download document |
III. Specifications regarding the drawing up of work procedures specific to the activities subject to approval control
download document
IV. Specifications regarding the approval of activities related to medical devices import
download document
V. Specifications regarding the approval of activities related to the installation and maintenance of medical devices
download document
VI. List of training providers on medical device legislation
download document