Before entering China’s healthcare market, we encourage every medical device company to have a thorough understanding of the country’s unique market environment to understand not only the market opportunities but also the realities.
Large or small, we engage manufacturers of all sizes in 1-on-1 pre-market consultation meetings where we review our market research for the particular medical device and key facts and trends about the China’s medical industry from a market and regulatory perspective.
We break down our consultation into two categories:
1. Market Research & Review
• Market Overview
How big is the relevant market today and what are the historical and projected growth rates going forward? We also delve into the nuances of China’s healthcare market and how it may differ from other countries.
• Main Competitors
Who are the primary players in the market today and what is their market share? We take a look at the most prominent imported and domestic brands and discuss current physician preferences and rationale.
• Product Potential & Positioning Strategy
After consulting with our Key Opinion Leaders (KOLs), we look at the device’s initial sales and annual growth potential. With the right technology and economics, together we can make inroads in the market against the current competition.
2. Regulatory Overview
• China FDA (CFDA) Overview and Regulatory Trends
The overarching regulatory body of China’s healthcare industry, we review what the CFDA is and how this organization has evolved overtime to better serve the medical device industry.
• Product Registration Consultation & Timeline
From start to finish, we outline the individual steps in the device registration process, whether clinical trials will be necessary, and an estimated timeline for registration completion.
• Tender & Listing System
“Tendering” and “Listing”; what do they mean for China, how long the process can take, and implications for your device.
• Product Reimbursement Situation
What does the current reimbursement situation look like for your device and do we project the CFDA to keep these reimbursement rates constant over time or to evolve as the market matures?
We partner with one of China’s most prominent and experienced registration agents, providing our clients with 2 major benefits:
1. Maximize Efficiency -> Minimize Time To Market
18 Months. This is the average period of time a new product spends in China’s cumbersome registration process.
We understand, along with our clients, that every month saved in registration is an additional month to solidify the product’s market share and build brand awareness.
By keeping in daily contact with our regulatory partner, we resolve registration issues immediately as they arise. From past experience, we anticipate where time inefficiencies occur throughout this process and work ahead of the timeline to prepare the correct documentation and coordinate for additional product testing, if necessary.
2. Maintain Accountability & Honest Partnership
To maintain transparency throughout the registration process, we introduce our clients to our regulatory partner so each side understands what is required throughout this process and each party’s expectations.
We found plenty of stories of product registrations gone wrong that unintentionally designated too much authority to the local distributor at the unfortunate expense of the manufacturer. We highly encourage our clients to register their products in a way that maximizes their flexibility and freedom to do what they want with their product in years to come, and advise how to do so.
When the device nears the end of the registration process, we begin the build the product’s market foundation by inviting key physicians (KOLs) from influential hospitals to learn about the product and encourage the necessary buy-in to get traction in the market.
We set up product events and training seminars with the goal of spreading awareness for the new medical device and ensure physicians, from the large mega-cities to the provincial towns, are correctly trained to use the device.