Medical Device Submissions & Market Registrations

A global medical device manufacturer needed to expand into multiple new markets across Europe, Middle East, and Asia-Pacific (EMEA & APAC). The challenge was to achieve quick and compliant registration of Class II and III devices while navigating diverse regulatory frameworks, multiple submission formats, and country-specific labeling requirements.

Vigilare’s Regulatory Affairs team provided end-to-end support including regulatory strategy, technical file preparation, labeling/packaging compliance, and direct liaison with health authorities.

Key achievements included the successful registration of more than twenty-five products across seven countries in just six months, achieving over thirty percent faster time-to-market. Vigilare standardized technical documentation to support future submissions, ensured compliance with regional labeling and regulatory requirements, and secured approvals with zero deficiencies reported during authority reviews, enabling rapid multi-market expansion.

Download the case study to see how Vigilare enabled faster approvals and global market reach.