Medical Device Registration

Risk-class assessment, technical & clinical dossier preparation, laboratory testing coordination, and EAEU conformity.

Medical Device Classification & Compliance

We guide manufacturers of Class I, IIa, IIb, and III medical devices through local safety and performance evaluations.

Regulatory support for medical device manufacturers entering Kazakhstan and EAEU markets.

  • check_circle Registration support
  • check_circle Regulatory documentation preparation
  • check_circle Regulatory pathway assessment
  • check_circle Communication with regulatory authorities
  • check_circle Compliance support

Laboratory & Clinical Testing Support

Full coordination of toxicological, technical, EMC, and clinical evaluation reports required by regulatory bodies.

Technical Testing Functional, electrical safety & EMC testing
Toxicological Evaluation Biocompatibility & biological safety assessments
Clinical Evaluation Clinical trials & literature-based efficacy reports

Ready to Enter Kazakhstan & EAEU Markets?

Let our regulatory experts guide your product through every step of the registration and compliance process. Reach out today for a no-obligation consultation.