19.07.2021
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 SARS-CoV-2 (self-testing) Antigen Rapid Test Kit, manufactured by BEIJING LEPU MEDICAL TECHOLOGY, China, if they have received the falsified EC certificate of conformity no. MDD-YD-0335853, which would have been issued by Notified Body TÜV Rheinland LGA Products GmbH, Germany (0197) on 2021-05-18, valid until 2025-05-18.
Or personal verification of the validity of the EC Certificate of Conformity held, we recommend checking the information contained in the following notification, posted on the website of the National Agency for Medicines and Medical Devices of Romania, section IMPORTANT NOTIFICATIONS – MEDICAL DEVICES:
04.09.2020
To the attention of all stakeholders (contracting healthcare units, importers and distributors of medical devices and so on)
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.