26.02.2021
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 Protective Clothing & Equipment, Sterile NaCl-solutions – Physical acting products for the treatment of gastro-intestinal disorders – Physical acting products for the treatment of topical applications – Products for the treatment of dry eyes – Products for the treatment of vaginal disorders – Products for alleviation of haemorrhoidal disorders – Products for the treatment of sore throat, dry cough and hoarseness – Physically acting products for the application on mucous membranes, manufactured by Medi-Inn GmbH, Germany, if they have received the falsified EC certificate of conformity no. 3558GB414200519, which would be issued for this manufacturer by Notified Body MEDCERT Zertifizierungs- und Prüfungsgesellschaft für die Medizin GmbH, Germany (0482), on 2020-05-19, valid until 2024-05-27.
The rightful holder of the CE certificate of conformity no. 3558GB414200519, issued by Notified Body MEDCERT Zertifizierungs- und Prüfungsgesellschaft für die Medizin GmbH, Germany (0482) on 2020-05-19, valid until 2024-05-27, is manufacturer Hälsa Pharma GmbH, Germany, for medical devices of type Isotonic NaCl-solutions – Sterile NaCl-solutions – Physical acting products for the treatment of gastro-intestinal disorders – Physical acting products for the treatment of topical applications – Products for the treatment of dry eyes – Products for the treatment of vaginal disorders – Products for alleviation of haemorrhoidal disorders – Products for the treatment of sore throat, dry cough and hoarseness – Physically acting products for the application on mucous membranes.
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.