Medical Devices access to Moldova market

November 7, 2017

 

According to the Association Agreement between the Republic of Moldova and European Union, legislation of the Republic of Moldova was harmonized and the European Directives related to Medical Devices were transposed into the following Government decisions:  

 

 

Starting from October 14, 2017 new law “On medical products” came in force in Moldova.  This law applies to medical devices, active implantable medical devices, medical products for in vitro diagnostics.

 

With the entry in force of the law, CE-marked medical products can be placed on the market on the basis of the National notification procedure.

The notification for the medical products must be registered in the State Register of Medical Products.

 

Medical products that do not bear a CE marking have to meet national conformity assessment procedure of the Republic of Moldova and pass the national registration procedure for that.

 

Medical products that are subject to clinical study can be placed on the market without CE mark if they meet relevant technical requlations requirements of Moldova, and are accompanyed with the declaration of conformity issued by the manufacturer. Such products should be approved with the departmental statutory act.

 

Thus, let’s summarize:

 

  1. Legislation of the Republic of Moldova was harmonized with the EU legislation.

  2. New law “On medical products” came in force from October 14, 2017.

  3. Notification procedure is applicable for the CE-marked medical products.

  4. Medical products that do not bear a CE marking have to meet national conformity assessment procedure of the Republic of Moldova.

  5. Medical products that are subject to clinical study can be placed on the market without CE mark if they meet relevant technical regulations requirements of Moldova.

 

Information has been prepared by the GMA Consult Group team.

 

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