21.07.2023
To the attention of all interested parties (importers, distributors, users – health units and patients)
The NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type: Sodium hialuronate injection, Cross-Linked Sodium Hyaluronate Injection by Genu Vida, various strengths, manufactured by Heil Pharma, India, marked on the packaging only with the CE marking, if they have come into possession of certificate no. BQC23HP44IN issued by BQS Certification Services, Brazil on 14-04-2023, valid until 13-04-2026, entity that does not have Notified Body status in Brussels according to Directive 93/42/EEC or Regulation (EU) 2017/745 on medical devices.
The introduction of this type of medical device on the EU market (class III) can only be done with the involvement of a Notified Body in Brussels according to Directive 93/42/EEC or Regulation (EU) 2017/745 on medical devices. In this case, devices of the type mentioned above must bear the CE marking accompanied by the identification number of the Notified Body in Brussels, involved in assessing the conformity of those devices with general safety and performance requirements applicable to the risk class to which they belong.
We hereby warn state and private healthcare facilities as well as patients not to use intraarticular medical devices ‘Sodium hyaluronate injection, Cross-Linked Sodium Hyaluronate Injection brand Genu Vida’, various strengths, manufactured by Heil Pharma, India, marked on the packaging only with the CE marking if they have come into possession of them and to notify the National Agency for Medicines and Medical Devices of Romania – the Market Surveillance Service using the contact details posted on the NAMMDR website, if they are aware of distributors who have marketed these medical devices on the Romanian territory.