The medtech sector is highly regulated, with significant variations in requirements and processes across different countries.

Before entering any new market, it is essential to consider:

• Device classification and regulatory requirements
• Authorised representation in the target market
• Documentation required for product registration
• Expected timescales for regulatory approval
• Need for local testing or clinical trials

Higher-risk devices may require additional performance testing, certification, or local evaluation to comply with national standards. Keeping up with the rapidly evolving regulatory landscape is a major challenge, especially for SMEs with limited in-house resources.

We work closely with trusted external experts to support you at every stage – from shaping regulatory strategy to preparing for product registration – ensuring your market entry is efficient, compliant, and well-informed.

Ready to expand your business?

Contact Medtech Global Trade Partners today for a free, no-obligation consultation.