Emerging medical device markets have grown rapidly, and the growth of the industry has been contributed to by increasing healthcare needs, population growth, and economic developments in these emerging regions.
As companies look at ways of increasing their footprint in such regions, successful registration for medical devices will be a vital step to access the new market. In particular, obtaining SFDA medical device registration is crucial for companies looking to enter the Saudi Arabian market, ensuring compliance with local regulations and enhancing market credibility.
In this blog, we will present the most difficult situations encountered by companies while doing their medical device registration in emerging markets and deliver practical strategies to overcome these problems to ultimately enter and emerge as a winner in these markets.
Diverse Regulatory Requirements
Regulatory harmonization is one of the major challenges in emerging markets. Countries have rather different regulatory frameworks, so it is not easy to apply a one-size-fits-all approach. Rules governing medical devices in Asia, Latin America, and Africa are extremely disparate from the point of device classification down to the required documentation for approval.
For example, Brazil, India, as well as China, all have their complicated medical device regulations that may be similar to some recognized frameworks in other parts of the world, especially concerning the FDA or European Medicines Agency (EMA), and each country has its demand for unique documentation and standards of compliance.
How to Overcome This Challenge: Companies should invest in regulatory intelligence and partner with local regulatory experts knowledgeable about country-specific regulations and procedures. Developing a deep understanding of the regulatory environment of each target country is critical.
Modular approaches, whereby you prep a comprehensive dossier of essential information, can also help streamline preparation for necessary local regulatory adjustments.
Inconsistent Classification of Medical Devices
The same medical device may fall into a different risk category in emerging markets, which complicates the registration process. What might be a low-risk classification in one region could be a high-risk classification in another, and that impacts the time, cost, and documentation required in the registration process.
For instance, Mexico has classified all its medical devices into three classes as well based on risk, similar to the European Union’s various classification systems. Other countries, such as India and South Africa, have differing structures of classification. These may vary concerning the pathway as well as the type of approvals that are required for registration.
How to Overcome This Challenge: Categorize an understanding of each market thoroughly before the application for registration begins. Consult local regulatory authorities or a third-party consultant experienced in the regulatory regulations of your target country.
Knowing how your device is classified will tell you more about the amount of scrutiny, so better prepare with documents in advance.
Limited Resources and Infrastructure
In many emerging markets, the regulatory bodies in charge of medical device registration are often under-resourced and possess very little infrastructure to address the increasing flow of applications. The registration processes, though sometimes taking months or even up to a couple of years, remain slowed in many emerging markets due to delays in review and approval.
For instance, in Africa, for example, Nigeria and Kenya, regulatory bodies may have resource constraints affecting the evaluation process’s progress. The infrastructure to consider evaluation for advanced or innovative devices can also be wanted.
How to Overcome This Challenge: All this requires patience and proactive planning. Companies should be prepared for extended timelines while ensuring that they are properly prepared and documented in all respects in compliance with local standards to avoid unwarranted delays.
Less Transparency and Communication
Most regulatory processes in many emerging markets lack transparency. The line of communication with regulatory bodies would be arduous to deal with; thus, understanding what submission requirements will be tough for the manufacturers.
In fact, for example, one may realize that regulatory bodies of certain countries do not provide a timeline at all or even a step-by-step process toward device registration. Companies may feel frustrated and perplexed by the lack of information on the local processes.
How to Overcome This Challenge: Communication channels are established first. Where possible, build relationships with local regulatory officials or hire in-country experts who have connections within the regulatory agencies.
In most cases, local experts will know how to navigate more effectively and hasten processes while easing communication gaps in your company’s communication with the regulatory body.
Cost and Time Considerations
The process of registering medical devices in emerging markets is very costly and involves many prolonged periods. Fees for registration, clinical trials, and representation in the territory can suddenly add to costs.
Additionally, the time involved in the document compilation and submission process, testing, and waiting for approval may cause a delay in access to the market, which impacts the company’s bottom line.
How to Overcome This Challenge: A detailed budget and timeline for the registration process, keeping in mind the possible causes of delay and unexpected expenses. Partner with a local distributor or agents. This can help you share some of the financial burden by maximizing their knowledge of the local terrain and infrastructure.
Additionally, possible submission options for group submission in countries that form part of regional regulatory initiatives such as the ASEAN Medical Device Directive may be cost-effective and faster.
Emerging markets are complex in themselves, given the uniqueness of medical device registration therein; however, the challenges are not insurmountable if the company aspires to the soft skills that are required. Soft skills evolved by gaining a deep understanding of local regulatory requirements, fostering local experts, and being flexible.
Proper planning and strategic execution are far from simple affair-reward entry into the rapidly growing markets, in turn granting access to millions of new patients and healthcare providers who require innovative medical technologies.
Article and permission to publish here provided by Atkinson Bell. Originally written for Supply Chain Game Changer and published on September 30, 2024.
Cover image provided by Atkinson Bell.