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Multinational IVD Compliance: Scalable Regulatory Intelligence for Multi-Country Submissions
- Abstract
- Problem Statement:
Explore how a leading New Zealand-based manufacturer of pulmonary care products sought to navigate the complexities of India's Public Procurement Order (PPO) regulations to participate in local tenders. Without a local office in India, the client faced significant challenges in understanding the nuances of medical device registration and compliance under the new CDSCO and Make in India policies. Our Regulatory Intelligence support provided the clarity needed for strategic market entry.
- The client struggled to comprehend the new CDSCO regulations and Make in India policies affecting medical device registration in India.
- There was uncertainty regarding the applicability of the PPO to foreign manufacturers and the specific requirements for local content.
- The client needed clarity on the categories of medical devices considered under PPO 2017 to effectively participate in tenders.
- Understanding the implications of the PPO for their products, including advantages, disadvantages, and compliance requirements, was critical for the client’s tender participation strategy.
