How to Import Your MedTech Product from Asia to the US
The US medtech industry is rapidly growing, providing innovations that are transforming and enriching patients’ lives. Bringing a medtech product to market from Asia to the US is a highly complex process, both logistically and creatively. We’ll walk you through US medical device regulatory requirements and marketing best practices, to help set you up for success.
Navigating US Regulatory Complexities
First, a look at projections for the medtech industry in the US. Specifically for medical devices, recent insights forecast that the US medical device industry will reach a revenue of $192.35bn by 2025. The top three markets during this time are expected to be cardiology, orthopedic, and ophthalmic devices. Whatever specialty your medtech product supports, patients and providers in the US are keen on embracing these technologies.
In the US, the importation of medical devices is managed by the FDA’s Center for Devices and Radiological Health (CDRH). In addition to CDRH regulations, medical devices imported into the United States must also meet the requirements of the U.S. Bureau of Custom and Border Protections (CBP). It’s important to note that the US does not recognize authorizations from outside the US – for example, Europe’s CE markings. Even if a product fully meets the requirements of its origin country or other regions, it must still align with US regulations as well.
The FDA’s basic regulatory requirements for medical devices include:
- Establishment registration
- Medical device listing
- Quality system
- 510(k), or premarket submission (unless an exemption applies)
- Premarket approval
- Labeling
- Medical device reporting
In some cases, there may be opportunities for this process to be expedited. For example, the FDA’s Breakthrough Devices Program can help speed up development and approval by providing organizations with access to FDA consultation and prioritized submission reviews. This program is available for medical devices specifically focused on the diagnosis and treatment of life-threatening or irreversible conditions.
The CDRH also operates the Safer Technologies Program (STeP). This program offers similar benefits to the Breakthrough Devices Program by way of FDA expertise and timely feedback, but differs in the type of devices that are eligible. The STeP program is designed for devices and device-lead combination products that diagnose and treat non-life-threatening or reversible conditions.
In addition to regulations surrounding US import requirements, consider data privacy, as well. From smart devices to digital marketing, you’ll need to ensure you align with US data privacy laws. This can be especially complex, as US states vary in their digital laws. For example, in California there’s the California Consumer Privacy Act (CCPA). This set of laws provides California consumers with more comprehensive rights and protections than other US states. Adhering to US state and national regulations not only safeguards patient data, but builds customer trust and loyalty.
Marketing Your MedTech Device in the US
With your compliance in order, you’ll then need to market your product. There are a host of opportunities to market your medtech device in the US, from PR initiatives to digital advertising and thought leadership content. As with any entry into a new market, understanding customer sentiment, expectations, and behavior is key to engaging the right audience.
For example, taking the time to discover buyer personas for your brand can set you up for sustainable growth. Understanding your audience’s demographics, needs, concerns, and challenges is essential in building out a marketing strategy. You should also consider tone, depending on whether you’re creating B2C (direct to patients) or B2B (towards healthcare organizations). Patients may connect best with content that is helpful, warm, and engaging, while decision makers at healthcare organizations may lock in on a more authoritative tone.
It’s also critically important to remember that marketing does not mean embellishing. In addition to managing medical device import requirements, the FDA – along with the US Federal Trade Commission (FTC) – monitors medical device advertising to ensure that product claims are accurate. Throughout all forms of content, the information you provide must be trustworthy, accessible, and comprehensible.
Creating an Informed MedTech Content Strategy
Then, there’s the creation and distribution of your marketing content. Here’s where your team has the opportunity to unleash their creativity and celebrate the value of your product. But what’s the best approach for your messaging? Trade shows, social media, medical journals, TV? With so many ways for consumers to glean information, plus the ever-changing nature of algorithms and digital platforms, there’s a lot to consider.
For teams based in Asia, there may also be unique challenges in creating a US digital marketing strategy. For example, organizations in China may not have extensive experience creating campaigns on Facebook and Instagram, yet they’re two of the top social media sites in the US and are heavily utilized by competing brands.
At Mind Machine, we have extensive experience helping organizations across the globe create their digital marketing strategies. We understand the cares and concerns of US consumers and healthcare organizations. We’ll guide your team towards discovering the most effective channels for your marketing content, and provide insights on creating content that informs and engages your audience.
Mind Machine Manages Both Compliance and Creative
There are many elements to consider in bringing a medtech product to market from Asia to the US, from US import requirements to insightful marketing. All of these endeavors are essential to your product development and launch, ensuring that your medtech product meets health and safety guidelines and is marketed in a way that reflects your expertise and values.
We support our clients throughout their product journey. In addition to guidance regarding US import requirements, our services cover all stages of product development, including:
- Investor fundraising
- Brand identity
- Pricing strategy
- Wholesaler/distributor planning
- Website design
- Campaign development
The US medtech industry is in a constant state of development. As technology continues to evolve, so will the compliance and import requirements for these innovative devices. From product development to compliance and branding, connect with our team to discover how we can support your organization at every phase of your journey.
About the Author
Charlene Petuship
Operations Specialist & Healthcare/Pharma Compliance Expert
Charlene is responsible for overseeing agency staffing, supervising the company’s daily operations, managing relationships with key vendors, and more. With over a decade of helping companies with traditional and unique requests, Charlene has been able to bring staff, tools, and project plans together in order to ensure every detail is addressed and accounted for. No matter what you need, Mind Machine is equipped to get you across the finish line.