Romania changes registration requirements for medical devices during state of emergency

On 31 March 2020, the Romanian Ministry of Health issued Order No 537/2020 amending Order No 1009/2016 regarding the registration of medical devices in the national database.

By this Order, during the state of emergency, the medical devices that should be registered with ANMDMR are exempted from this obligation if they ensure the prevention and treatment for infections during the state of emergency.

A producer or an authorised representative in Romania can place these medical devices on the market on the basis of a declaration of conformity. (More information on the declaration of conformity can be found on ANMDMR’s website – www.anm.ro).

Further to this Order, on 5 April 2020, the National Agency for Medicines and Medical Devices of Romania (ANMDMR) announced that Class I Medical devices such as masks, smocks and hazmat suits are no longer registered in the national database of medical devices during the state of emergency, which is expected to be extended until 16 May. Furthermore, the ANMDMR announced that the Romanian Standardisation Association offers temporary access free of charge to Romanian standards, which are identical to European international standards, for devices and equipment deemed indispensable in the current situation, such as common filtration masks, medical gloves and protection clothing. These are available to all interested persons by accessing the Standard COVID-19 Package (www.asro.ro/pachet-standarde-covid-19/).

In addition, parties interested in performing the laboratory testing of products that they intend to place on the market can contact the following institutions: the Military Equipment and Technologies Research Agency, the Medico-Military Scientific Research Centre and the CBRN1 Defence and Ecology Scientific Research Centre.

For more information on Romania's pharmaceutical and medical supply markets, contact your regular CMS advisor or local CMS experts Valentina Parvu and Cosmin Cretu.