Expanding into new foreign markets is an exciting chapter for any medical device manufacturer.
However, it can also be pretty intimidating.
Each market is a unique geographic region, with its own unique set of regulatory requirements, operational challenges, and patient populations. And without a deep understanding of the local habits, it’s unlikely your device launch will find much liftoff.
In the 2023 MedTech Industry Benchmark Report, respondents listed supply chain logistics as their greatest obstacle for growth. We usually think of upstream suppliers, but downstream members of the supply chain – such as importers – can be just as critical.
The good news is that by carefully assessing importers based on market knowledge, distribution capabilities, and regulatory compliance, manufacturers can forge valuable partnerships that lead to seamless distribution, drive demand, navigate regulatory affairs, and ensure reimbursement.
Let’s take a closer look at how medical device manufacturers can navigate the process of assessing importers and creating a robust market access plan.
Understand the role and responsibilities of medical device importers
To provide trusted guidance in new and unfamiliar foreign markets, medical device manufacturers often turn to third-party importers for help. The relationship between medical device companies and importers is a symbiotic one, where both parties contribute to achieving the mutual goal of getting devices into the hands of end-users who need it most.
Broadly speaking, Importers commonly assist medical device manufacturers with tasks, such as:
- Navigating regulatory landscapes and ensuring compliance with local requirements
- Establishing distribution networks, including hospitals, clinics, wholesalers, and retailers
- Providing valuable insights into local market dynamics, customer preferences, and competitive landscape
- Mitigating operational challenges like logistics, customs procedures, language barriers, and cultural differences
However, the role of importer is often confused or conflated with other similar roles within the medical device supply chain, such as a distributor. While importers enable manufacturers to initially place new medical devices in the foreign market, distributors are focused on the logistics of inventory management, order processing, delivery logistics, and customer support.
This distinction is so important that we have explicit guidance on the subject from regulatory bodies. Let’s take a look at how the FDA defines importers in 21 CFR Part 803:
An importer is any person or entity who furthers the marketing of a device from the original place of manufacture to the person who makes final delivery or sale to the ultimate user, but who does not repackage or otherwise change the container, wrapper, or labeling of the device or device package.
The EU’s Medical Device Regulation (MDR) breaks the concept down further into its list of four economic operators: manufacturers, importers, distributors, and authorized representatives. Here, we get even more specific with the expectations and responsibilities of importers.
The importer is defined as any natural or legal person who places a product from a third country on the EU market. The importer must ensure that the manufacturer has correctly fulfilled his obligations. The importer is not a simple reseller of products, but has a key role to play in guaranteeing the compliance of imported products.
From these two definitions, we can surmise that an importer places medical devices on the market for the first time, while distributors are responsible for devices placed on the market the second time (or as many times as it takes until they reach the end user).
In some cases, a company can perform both roles as an importer and a distributor, especially when they have expertise in both importing and distributing medical devices.
Verify medical device importer compliance with regulatory requirements
Now that we have a firmer understanding of what medical device importers can do, let’s take a look at what the regulatory requirements say they must do.
Remember! Ensuring that importers have a solid understanding of local regulations and possess the necessary certifications and licenses is ultimately your responsibility. That means your due diligence should carry over into auditing foreign importers against their market’s regulatory requirements.
In general, medical device importers should always have the following:
- Knowledge of local regulation such as registration processes, labeling and packaging regulations, importation permits, and post-market surveillance obligations
- An established quality management system (QMS)
- Documentation on file, such as regulatory filings, certificates, and audit reports
- A proven track record of compliance
However, these essentials are only a starting point. To get an even clearer picture of a potential importer’s regulatory competence, you’ll need to examine the specific requirements of the given market.
Importer requirements in the EU
As mentioned earlier, the MDR designates importers as one its primary economic operators. While the manufacturer is responsible for obtaining a CE marking, importers act as a form of checks and balances to ensure the following:
- The appropriate conformity assessment procedure has been carried out by the manufacturer.
- That the manufacturer has drawn up the technical documentation, affixed the relevant conformity marking (e.g. CE marking), fulfilled his traceability obligations and accompanied, where relevant, the product by the instructions and safety information in a language easily understood by consumers and other end-users, as determined by the Member State
From there, the legislation explains that device importer must also:
- Indicate their name, registered trade name, or trade mark the address at which he can be contacted on the product
- Ensure that, while a product is under his responsibility, storage or transport conditions do not jeopardize its compliance with the requirements set out in the applicable legislation.
- Keep a copy of the EU Declaration of Conformity for 10 years after the product has been placed on the market
- Ensure that the technical documentation can be made available to the competent national authority upon request in a language which can be easily understood by that authority.
- On request by market surveillance authorities, the importer must identify any economic operator who has supplied him and to whom he has supplied the product.
Importer requirements in the US
Per FDA’s directive, an initial importer of a medical device is required to comply with the following regulatory requirements:
- Establishment registration
- Medical Device Reporting (MDR) (21 CFR 803)
- Reports of Corrections and Removals (21 CFR 806)
- Medical Device Tracking (21 CFR 821), where applicable.
Additionally, an importer is required to report incidents in which a device may have caused or contributed to a death or serious injury as well as certain malfunctions. That also means that an importer must maintain an MDR event file for each adverse event.
In fact, all product complaints including MDR and non MDR events, must be forwarded to the manufacturer. Under the Medical Device Tracking regulation, certain devices must be tracked through the distribution chain.
Evaluate whether potential medical device importers can meet your needs
With the roles and regulatory requirements out of the way, it’s time to dig into evaluating importers based on your company and device’s needs.
When evaluating the capabilities of potential importers, medical device manufacturers need to assess operational factors, reimbursement capabilities, and the potential contribution to the market access plan.
Operational considerations
Even though importers don’t handle distribution activities, they will be establishing some of those key distribution networks and assisting with making the right connections for you to successfully sell your device overseas.
With that in mind, manufacturers should evaluate the importer’s distribution network and reach within the target market. This includes the importer’s coverage of healthcare facilities, clinics, hospitals, and retail outlets. You’ll also want to determine the extent of their geographic reach and their ability to access key distribution channels.
Sales and marketing capabilities are also important. You’ll need to evaluate the importer’s ability to effectively promote and sell medical devices in the target market. Consider factors such as their salesforce expertise, marketing strategies, and engagement with healthcare professionals and key opinion leaders.
Additionally, manufacturers should assess the importer’s ability to provide technical support and training to healthcare professionals and end-users. This might mean conducting product demonstrations, organizing training sessions, and offering post-sales support. Whatever the form, effective technical support ensures proper usage of the medical devices.
Reimbursement considerations
Understanding and navigating the reimbursement landscape is already difficult enough in your home market. But when seeking to secure coverage and payment for medical devices by insurance providers, government healthcare programs, and other payers in a new market, it can become even more complex.
When it comes to researching local reimbursement systems and policies, it’s crucial to have a solid understanding of how things work in your target market.
Take the time to explore how reimbursement mechanisms function, what criteria are considered for coverage, the coding systems in place, and the rates at which reimbursement is provided. By doing so, you’ll be able to spot both challenges and opportunities specific to your medical devices, which will greatly assist you in determining your pricing strategies and engaging in reimbursement negotiations with payers.
It’s also important to identify any potential hurdles that may arise in the reimbursement process. Look out for pricing restrictions, timelines for reimbursement, and any specific market access requirements that may affect your medical devices.
On the flip side, be on the lookout for opportunities that can improve your chances of securing reimbursement. This could involve generating clinical evidence, collecting health economic data, and effectively demonstrating the value that your medical devices bring.
Market access considerations
The best foreign importers can provide medical device manufacturers with a foundation for success. And while they may not be the ones ultimately delivering your product to the end users, you should still be evaluating their ability to contribute to your market access plan.
Importers bring a wealth of local knowledge and expertise to the table. They understand the customs procedures and market dynamics that are unique to the target market. This knowledge allows them to shed light on the specific challenges and opportunities that the manufacturer’s products may encounter when it comes to gaining market access.
One of the importers’ strengths lies in their established distribution networks. They have already built connections and partnerships in the target market, which enables them to efficiently distribute and deliver the manufacturer’s products to various healthcare facilities, providers, and end consumers. This wide-reaching network greatly benefits the manufacturer in reaching a broader customer base.
Importers also excel in relationship building with key stakeholders in the local market, including healthcare providers, hospitals, and government authorities. By leveraging these relationships, importers can help introduce the manufacturer to these important players and facilitate partnerships.
Choose the only purpose-built QMS solution that grows with your MedTech business
As your MedTech company evolves into new markets, you’ll undoubtedly face obstacles. With increasing complexity, what once worked for you may be insufficient. That’s why Greenlight Guru has the best fit solutions to mitigate these growing pains and enable you to spend more time doing what you love — innovating and improving the quality of life.
Greenlight Guru’s QMS is the #1 modern QMS used by over 1,000 medical device companies to deliver innovations to the market, streamline compliance, and focus on quality. You know what it takes to bring a product to market, so let us show you how we can make it easier, faster, and better and exceed your growth expectations.
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- Source: https://www.greenlight.guru/blog/medical-device-importers
