Services for Device Registration in Latvia

Background

Under the Latvian Regulation No. 581 adopted on 2 August 2005 by Cabinet of Ministers, three categories of medical devices require to be registered with the State Agency of Medicines of Latvia (ZVA) at the time of being put into service within Latvian territory. (Please see Article 1 General Provision, paragraph 20 of the Regulation No. 581)

Categories of medical devices concerned by this obligatory communication are:

  • Class IIb medical devices
  • Class III medical devices
  • Active implantable medical devices (AIMDD)

Registration Process

The registration process consists of following 5 steps:

  1. Designation of an E.A.R.!
  2. Provide E.A.R. with relevant documentation (to be provided upon request)
  3. E.A.R reviews your documentation 
  4. E.AR communicates the information to ZVA
  5. Information available in LATMED

Additional Information:

Medical devices having same intended use (same commercial name, the same EC declaration of conformity and the instruction for use) are subject to only one communication. The communication must be made at the time of the putting the medical device into service (article 1 of the MDD 93/42/EEC) onto the Latvian territory.

Please bear in mind, that if the communication is not submitted at the time the device is put into service, the manufacturer is subject to penalties.

Third party commercial entities, like distributors, should not register devices for several reasons, a few of which are:

  1. By allowing a third party commercial entity to register in your behalf, the manufacturer relinquishes an essential part of his control over his product in the European Market (such as in Latvia);
  2. If decided to end the relationship with a commercial distributor at any point, it will be required to take the device completely off the market until a re-registration is completed for a second (third, fourth, etc.) time;
  3. Third party commercial entity will expect exclusivity, limiting the open distribution of devices.

Conclusion:

  1. For the benefit of non-EU manufacturer, the distributor SHOULD NOT have part in any regulatory affairs;
  2. The manufacturer should register their products with the Latvian Authorities through his appointed Authorized Representative.

Local Legislations, such as this one, are growing rapidly in Europe (Italy, Portugal, France, Germany and Latvia) and strengthen the need for a professional European Authorized Representative present at all times.


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