Published on 26 Jun, 2025
The global medical device industry is witnessing rapid growth, fueled by technological advancement and increasing healthcare demands. In response, regulatory bodies worldwide have reinforced approval processes to uphold safety, quality, and trust—making regulatory navigation a pivotal aspect of international expansion for startups and manufacturers.
This whitepaper offers a clear and actionable framework to help medical device innovators enter global markets with confidence. It outlines critical components such as product classification, regulatory regimes, appointment of in-country representatives, and the acquisition of Free Sales Certificates. It also explores how leveraging approvals from reference countries can ease subsequent market entry, particularly for companies already approved by CDSCO.
By shedding light on regulatory diversity, compliance costs, and the importance of harmonization through international standards, this guide equips stakeholders with the tools to anticipate challenges, bridge capability gaps, and accelerate their global journey.