The import and / or distribution of medical devices represents the activities carried out by economic operators regarding the acquisition, possession and wholesale or retail supply of medical devices, including the distance sale of medical devices. The listed activities are carried out by economic operators, authorized natural or legal persons.

The activities carried out in the field of medical devices are subject to prior approval at the A.N.M.D.M.R – National Agency for Medicines and Medical Devices in Romania based in Bucharest. The operating permit is issued at the request of the economic operator and is registered in the database of the A.N.M.D.M.R.

The medical devices are sold on the Romanian market only based on the operating permit issued by the A.N.M.D.M.R, and the sanction in case of non-compliance with the approval obligation is sanctioned with a fine between 5,000 LEI and 10,000 LEI.

In order to obtain the operation permit, the economic operator has the obligation to submit to A.N.M.D.M.R a request in this respect, accompanied by a complex set of documents.

The documents that make up the approval file must comply with certain rigors, given the fact that the activities in the field of medical devices are checked in detail by the representatives of the authority, so as to avoid the introduction on the market of non-compliant products.

The submission of the approval file does not implicitly imply the issuance of the approval, because the A.N.M.D.M.R representatives may request additional technical documents provided in the legislation applicable to the type of imported / distributed device.

Also, in order to approve the activity of an economic operator, A.N.M.D.M.R, based on its own procedure and the documents submitted to the file, evaluates the competence and the capacity of the applicant to carry out the respective activities.

In order to obtain the operating permit, an economic operator must cumulatively meet the following requirements:

1. to have an adequate space, which must be used exclusively for carrying out the activity required for approval;
2. to be equipped with adequate equipment for carrying out the activity required for approval;
3. to have sufficient and qualified / trained personnel for the activity they carry out / the field in which they operate.

This necessary expertise is demonstrated by diplomas, certificates or other evidence of formal qualification (university studies in the field of engineering, chemistry, medicine, etc.), as well as by other documents granted at the graduation of continuing education courses having as subject the legislation in the field of medical devices. In this regard, A.N.M.D.M.R approved a list of training providers on the subject of legislation in the field of medical devices.

For the analysis and issuance of the operating permit, A.N.M.D.M.R will communicate an assessment fee that the operator has the obligation to pay, and within a maximum of 120 days the authority will prepare the assessment report and order the issuance of the operating permit for the concerned operator.

The operating permits issued by the A.N.M.D.M.R are valid for a period of 3 years from the date of issue, if the conditions underlying the approval remain unchanged.

A.N.M.D.M.R may carry out unannounced checks on economic operators carrying out activities in the field of medical devices, and in case of non-conformities (eg. unqualified / untrained personnel, improper storage space, etc.), the operating permit is suspended until the non-conformities are eliminated, for a maximum period of 3 months. It is forbidden to carry out the activity during the suspension period.

If, within the term established by the authority, the non-conformities found are not remedied, A.N.M.D.M.R cancels the issued permit.