Services

Regulatory Affairs

The Medical Devices industry is one of the world’s most regulated and one of the most challenging industry in term of the regulatory requirements and compliance. Uniclue offer a compliant regulatory framework for your company, we can help you to understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in order to successfully launch your products in new markets and maximize their market value.

Regulatory Affairs

  • Registration/Re-registration of Medical devices and IVDs.
  • Importation approvals.
  • Custom approvals
  • Importer Registery.
  • Inspection.
  • NODCAR Analysis.

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