Discover how to navigate commercial and regulatory challenges for global success in the medical device industry. Learn strategies for market access, regulatory compliance, and post-market vigilance
When expanding into global markets as a medical device company, the market access strategy involves making regulatory strategic decisions in addition to commercial strategy to achieve long-term success. Expanding globally offers numerous advantages and can be very rewarding. Entering into new markets broadens the scope of your business and generates a new customer base. This diversification not only increases revenue but also strengthens your brand presence on a global scale and builds shareholder value. Moreover, engaging in international business often entails travel, providing opportunities to meet individuals from various cultural backgrounds and gain invaluable insights into different markets.
However, global expansion also comes with its fair share of challenges. Dealing with different languages, cultures, and legal frameworks can be daunting. Additionally, navigating through complex regulatory requirements and potential financial risks requires careful planning and execution. Successfully expanding into global markets requires making informed commercial and regulatory strategic decisions. Here are key considerations:
Commercial Strategy:
- Market Research: Conduct thorough market research to assess market potential and prioritize target markets.
- Sales and Distribution Channels: Research and due diligence of potential sales and distribution channels in each target market.
- Local Partnerships: Select reliable local partners or establish your own sales office to facilitate market entry.
Regulatory Strategy:
- Regulatory Compliance: Conduct regulatory research to understand local regulatory requirements and assess product registration risks.
- Representation Partners: Choose local partners for product registration and representation based on market-specific priorities and regulatory considerations.
- Post-Market Vigilance: Establish a global strategy for aligning post-market vigilance compliance across all markets.
Whether you're a newcomer to global markets or already have an established international presence, making the strategic decision about who has market access control is crucial for successful global business. In addition to having control over sales and distribution channels in each market, you need to determine and decide who controls product registrations and importations in each market and how to organize post-market vigilance.
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Explore our collection of articles, success stories, and regulatory updates, designed to help you take your product global.
The IVDR transition includes structured processes IVD manufacturers must follow to engage with Notified Bodies. Many IVD manufacturers are interacting with Notified Bodies for the first time and must understand what is required to ensure a successful partnership. In this article, Dr. Oliver Eikenberg clarifies what manufacturers must prepare and when to engage a Notified Body for IVDR CE Marking.
Class D IVD manufacturers face fast-approaching IVDR transition deadlines, though some are more familiar with the regulatory process. In this article, Dr. Oliver Eikenberg discusses the difference between "new" and "old" Class Ds, and regulatory logistics they need to consider during the transition process.
Your IVD's intended purpose determines its classification, clinical evidence requirements, and clinical applications under the IVDR. Device companies will need a more robust intended purpose to fulfill IVDR criteria. In this article, Dr. Oliver Eikenberg explains the role of the intended purpose in IVDR compliance.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
