[Contribution] What medical device companies need to know when entering the U.S. - FDA approval process and entry strategy
Attorney Daeryun Lee Il-hyung " FDA, AIand IoT Strengthening regulations on medical devices-Strict marketing regulations""FDA Permit process is complex but predictable...Compliance investment is a necessity, not an option" Contributors and Pharmacy Newspaper 「medical device」We planned a series related to. In this article, we will look at the legal regulations and entry strategies of domestic medical device companies when entering the U.S. market.. 1. Recently, the rush of Korean medical device companies to enter the U.S. continues.. K-Following beauty success K-This is because the potential for global expansion of medical technology is attracting attention.. However, when we meet companies preparing to enter the U.S. market, FDA Many people are confused when faced with the complexity of the permitting process and various entry strategy options.. The contributor recently held consultations with dozens of companies through a COEX consultation booth event., Recognizing that most of the questions the working-level staff were curious about overlapped, we felt the need to organize key points.. In this contribution FDA We would like to introduce content that may be helpful to practitioners, focusing on the permitting process and proven entry strategies.. 2. FDA Permit Procedure, America is trickier than you think FDAAccording to the risk posed to patients, medical devices are Class I, II, IIIDivide and manage into. Because the permit procedures required for each grade are different,, Above all, the first hurdle is to find out exactly what grade your product falls into..Class I The product may seem relatively simple, but, not really. mostly 510(k)is exempted, but FDA Facility registration and equipment list registration are required., Compliance with the quality system is also essential.. In particular, products that are classified as quasi-drugs or cosmetics in Korea may be treated as medical devices in the United States, so caution is required.. Class II This is the area that most product companies worry about.. 510(k)Equivalence with existing approved products must be proven through, The key here is appropriate Predicate Deviceis to find. Even products with the same function predicate device Permission may vary depending on selection.. FDA The review period is officially 90It's work, but, In reality, if you request additional data or go through a supplementary process, 4-6It usually takes months. Class III Product is the most demanding area. Fillers are a representative example., PMA(Pre-market approval)Large-scale clinical trial data is needed to receive. Minimum permit period 180It can take anywhere from one day to several years, so there is sufficient time, Must be approached with financial resources. 3. Direct payment or indirect payment?, That is the problem. The biggest concern for Korean medical device companies is their entry strategy.. It is largely divided into a direct payment method that sells directly to hospitals and a short payment method that uses distributors.. The biggest attraction of direct payment is profitability.. Since there are no distributor commissions, you can maximize your margins., You also have direct control over brand management and customer relationships.. Additionally, you can receive direct feedback from hospitals and medical staff, which is advantageous for improving products or identifying market trends.. However, the reality of direct payment is not easy.. A large initial investment is required to deploy sales personnel and build a logistics system throughout the United States.. The burden of understanding and responding to different regulations in each state is significant.. One large medical device company also attempted direct sales at first, but eventually switched to partnering with partners.. On the other hand, the biggest advantage of Gannap is quick market entry.. The initial investment burden is low as you can utilize already established distribution networks and customer relationships., Distributors are also responsible for complex regulations and logistics procedures.. However, profitability declines due to distributor commissions., The downside is that it is difficult to directly control brand management or customer relationships.. In case of short payment GPO(Group Purchasing Organization)me DistribuotrA representative method is to use. However, they are price competitive, product competitiveness, Because we attach great importance to supply stability, having sufficient competitiveness is a priority.. 4. Practical know-how found in success stories Looking at the cases of companies consulted by the contributor, several patterns are identified.. For products dealing with rare or unique diseases, direct delivery was advantageous.. This is because a direct approach is more effective in areas where patient numbers are limited and expertise is important.. On the other hand, general consumables or general-purpose medical devices were often cheaper..A medical device company was attempting direct delivery by establishing a U.S. corporation based on its differentiated technological capabilities as the world's first developer.. On the other hand, disposable medical device manufacturers chose a strategy of gradually expanding the market, starting with government bidding.. This is a method of expanding into the private market after gaining experience in the government market where information is relatively open and entry barriers are low.. 5. Latest regulatory trends, Points you shouldn't miss FDAIs AIand IoT Regulations on basic medical devices are being strengthened.. In particular, continuous learning AI For algorithms, the existing 510(k) A new regulatory framework is being developed as the system is difficult to manage.. Companies developing these products must carefully monitor regulatory changes.. Marketing regulations are becoming more stringent.. FDA Advertising for uses outside of the approved indications or claiming exaggerated effects may result in severe sanctions.. UDI(Unique Device Identifier)This is also a part that cannot be overlooked.. Class I Even if it is a product UDI Attachment and GUDID Registration is often required, You must understand the exact requirements in advance. 6. Conclusion and Recommendations The US medical device market is certainly attractive, but, Thorough preparation is essential for success. Above all, it is important to accurately understand the characteristics of your products and company capabilities and then select an appropriate strategy.. FDA The permitting process is a complex but predictable area.. Trial and error can be minimized if you prepare sufficiently in advance and get help from experts.. Especially in recent times where the regulatory environment is rapidly changing, investing in compliance has become a necessity rather than an option.. Korea’s medical device industry’s technology has already reached a world-class level.. Now, I am confident that if we have a systematic entry strategy and ability to respond to regulations, we will be able to succeed in the U.S. market.. [View full article]
[Contribution] What medical device companies need to know when entering the U.S. - FDA approval process and entry strategy (link)