DANTE INTERNATIONAL S.A., having its headquarters in Romania, Bucureşti, Şos Virtuţii nr. 148, sector 6, registered at The Registry of Commerce under no: J40/372/2002, Unique Registration Code: RO 14399840, hereinafter reffered to as eMAG („eMAG”),
Considering:
- Directive 93/42 /CEE concerning medical devices;
- Law 95/2006 regarding the health system reform;
- Rules regarding selling the products through the eMAG Marketplace platform;
We inform you of the following:
- According to the legal provisions in place, established by the Directive 93/42, pulse oximeters are class II medical devices, subclases IIa and IIb, for selling the products are required the following documents:
- Declaration of conformity CE, drafted by the manufacturer;
- Certificate of Conformity CE, issued by a Notified Body on European Union with atributions given by Directive 93/42;
- Additionally, according to national legal provisions, established by Law 93/42, for carrying out activities in the field of medical devices (selling, import, distribution, installation and / or maintenance), are required the following documents:
- The approval issued by the National Agency of Medicines and Medical Devices in Romania (ANDMDR) regarding the development of activities for import / distribution of medical devices;
- The certificate of registration of the medical device in the National Database of Medical Devices;
- Proof of the notification of commissioning of the medical device issued by the National Agency of Medicines and Medical Devices of Romania (ANDMDR) within the mentioned legal term.
Considering the current context, created by the Sars-CoV-2 pandemic and the increased demand for these products and the existence of a high number of non-compliant products that have been made available to consumers by certain economic agents, to ensure a higher transparency on this category level and a much more complete and accurate presentation of the information, but also as a result of the erroneous use of the association function by certain Sellers, for the products listed in „pulse oximeters” the product association function will be no longer available. All offers listed which where associated on existent products have been disassociated.
Therefore, for the products that have been disassociated, it is necessary to list them as new products, in compliance with the previously mentioned requirements and to insert in the product gallery the documents indicated in the present notification.
For the situations in which you are the holder of documentation, it is necessary to upload in the product gallery the previously mentioned documents, within 3 days from this notification. Otherwise, the products will be blocked, the unblocking can occur only after the products are brought to conformity.
We thank you for your cooperation.
DANTE INTERNATIONAL S.A.
