Assessment of compliance of medical devices and equipment with requirements of technical regulations

  • Counsel on the preparation of declaration of conformity (with annexes) of technical regulations;
  • Counsel on the compliance of technical documentation of the manufacturer of medical devices with requirements of the Ukrainian legislation;
  • Assistance in the preparation and development of technical documentation;
  • Support during the audit of production facilities for compliance with production quality management systems;
  • Preparation of documents for audit by the State Administration on Medical Products and Drug Control.

  • Services for medical institutions Services for medical institutions

  • Public procurement of medicines and medical devices Public procurement of medicines and medical devices

  • Confirmation of compliance with the GMP requirements Confirmation of compliance with the GMP requirements

  • Clinical studies Clinical studies

  • Import and export of medicines and medical devices Import and export of medicines and medical devices

  • Medicine advertising Medicine advertising

  • Declaration of wholesale and selling prices Declaration of wholesale and selling prices

  • Registration of drugs Registration of drugs

  • Licensing of manufacturers and distributors of medicines Licensing of manufacturers and distributors of medicines

+380 44 581 1220

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