11.03.2021
To the attention of all importers and distributors of medical devices
The National Agency for Medicines and Medical Devices warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type Cross-linked Hyaluronic Acid Dermal Filler with PDRN, for which a falsified copy of the CE Certificate of Conformity No. 2017-MDD/QS-044 was detected on the EU market, issued by Notified Body 3EC International a.s., Slovakia (2265) on 2017-10-02, valid until 2022-10-01.
For personal verification regarding the validity of the EC Certificate of conformity you own, please consult the information posted on the website of Notified Body 3EC International a.s., Slovakia, by accessing the links below:
https://www.3ec.sk/en/services/falsificates/
https://www.3ec.sk/en/services/suspension-or-withdrawal-of-certification/
To prevent the entry into the legal distribution chain, especially in the context of the COVID-19 pandemic, of non-compliant medical devices, which do not comply with applicable regulatory requirements, please exercise extra caution, permanently check the website of the National Agency for Medicines and Medical Devices of Romania for such notices and make sure that the products you purchase come from distributors approved by our institution, in line with the provisions of Art. 926 of Law 95/2006 on healthcare reform, republished, as further amended and supplemented.