Design Protection for Medical Devices

<p>Although great strides have been made to tackle hospital-acquired pressure ulcers (HAPUs), there is a need for greater recognition of device-related pressure ulcers (DRPUs), including their causes, management and prevention. This consensus statement, an updated second edition, aims to continue raising awareness of these largely preventable injuries and, crucially, to stimulate action. DRPUs are relatively common and account for a growing proportion of HAPUs. Updated information on the incidence of DRPUs is described in chapter 1. Although it is recognised that DRPUs increase the financial burden of healthcare, there is little formal analysis of their economic impact. This needs to be addressed; robust evidence on the burden of DRPUs and the value that can be released by adopting prevention strategies is needed to help drive action. Our understanding of the pathophysiology of DRPUs has improved significantly over the past few years; this is described in chapter 2. One crucial difference between PUs and DRPUs is that body-weight forces are less significant in DRPUs, with the force being exerted from a device that is typically strapped or taped onto the body. Devices and their securement may generate high stress concentrations in tissues, leading to cell and tissue-damage pathways associated with sustained deformation. As more evidence is published on DRPUs, recurring themes are emerging, as outlined in chapter 3: The most vulnerable patients are bearing the brunt of DRPUs; paediatric and neonatal patients, and all those needing critical care are particularly susceptible. During the COVID-19 pandemic, a new high-risk population (people with severe COVID-19 infection) emerged. They are at increased risk of DRPUs because of their need for prolonged ventilatory support, especially when 'proning' Devices associated with DRPUs are often used to perform essential, life-saving functions. They include continuous positive airway pressure (CPAP) masks or endotracheal tubes. Minimising their use is clearly not an option, so practice innovation is needed Although the most common locations for DRPUs are the face, ears, lower legs and heels, any location where a device comes into close contact with the skin can be at risk. In the same vein, any device, whether needed for a medical purpose or not, has the capacity to cause injury if its use is not properly managed. Vigilance is needed for all patients. What can be done? The importance of routine risk assessment is covered in chapter 4. Although use of a validated risk assessment tool is the vital first step, this will not be enough on its own. Several steps can be taken to ensure the safe use of devices. These are described in chapter 5 and include device repositioning, cushioning with prophylactic dressings and moisture control (only where possible and clinically appropriate). Of key importance is the development of an institutional protocol and champions to ensure all necessary steps are adopted. For any of these changes to be put into practice, awareness of DRPUs needs to increase. A number of proposals are outlined in chapter 6. A change of focus among health professionals and policy makers, along with more investment in education and training, are needed. All patients being managed with a medical device must be considered as at high risk. The pandemic introduced the world to the problem of DRPUs in health professionals caused by the extended wear of personal protective equipment. Health professionals also have a right to expect institutional protocols and provision of devices that protect them from DRPUs. Cutting-edge ideas and technologies that may be available in the future are described in chapter 7. When designing new products, manufacturers of medical devices have a duty of care to investigate the risks of DRPUs associated with their products and mitigate them, wherever possible. Our developing understanding of how the design, structure and materials used in medical devices contribute to DRPUs will help us develop new solutions for tomorrow. The first step is for everyone involved to ask themselves, 'what can I do to help?' There is work to be done-your journey to reduce DRPUs starts here!.</p>

Background: The integration of medical devices with artificial intelligence (AI) software is rapidly advancing as technology progresses. AI machine learning can be used in commercial medical services to generate practical data; there is evidence that it can be integrated into newly developed devices. However, such devices must undergo approval, regulation, and supervision. The Food and Drug Administration approves regulations for numerous machine-learning medical devices and shares open lists with the public. In this article, we examine recent medical AI devices in different fields, including the diagnosis of colorectal polyps.Current Concepts: Currently, in the field of gastroenterology, there has been a significant amount of research aimed at enhancing adenoma detection rates using tools powered by AI, such as the EndoScreener and GI Genius. Various such devices have also been developed for other fields; examples include the 23andMe Personal Genome Service for DNA detection, Spectral MD’s DeepView platform for wound imaging in surgery, Gili Pro BioSensor for monitoring vital signs, DreaMed Advisor Pro for diabetes, Minuteful for urinary analysis, BrainScope TBI for cerebral diagnosis, Compumedics Sleep Monitoring System for sleep disorders, Idx-DR v2.3 for ophthalmology, and EarliPoint system for pediatrics.Discussion and Conclusion: By the time this article is published, it is likely that even more AI medical devices will have been approved and commercialized. The development of such devices should be strongly encouraged. Additionally, we anticipate greater involvement from practitioners in the development and validation of diverse medical AI devices in Korea.

In these days, patients and doctors in operation room are surrounded by many medical devices as resulting from recent advancement of medical technology. However, these cutting-edge medical devices are working independently and not collaborating with each other, even though the collaborations between these devices such as navigation systems and medical imaging devices are becoming very important for accomplishing complex surgical tasks (such as a tumor removal procedure while checking the tumor location in neurosurgery). On the other hand, several surgical robots have been commercialized, and are becoming common. However, these surgical robots are not open for collaborations with external medical devices in these days. A cutting-edge "intelligent surgical robot" will be possible in collaborating with surgical robots, various kinds of sensors, navigation system and so on. On the other hand, most of the academic software developments for surgical robots are "home-made" in their research institutions and not open to the public. Therefore, open source control software for surgical robots can be beneficial in this field. From these perspectives, we developed Open Core Control software for surgical robots to overcome these challenges. In general, control softwares have hardware dependencies based on actuators, sensors and various kinds of internal devices. Therefore, these control softwares cannot be used on different types of robots without modifications. However, the structure of the Open Core Control software can be reused for various types of robots by abstracting hardware dependent parts. In addition, network connectivity is crucial for collaboration between advanced medical devices. The OpenIGTLink is adopted in Interface class which plays a role to communicate with external medical devices. At the same time, it is essential to maintain the stable operation within the asynchronous data transactions through network. In the Open Core Control software, several techniques for this purpose were introduced. Virtual fixture is well known technique as a "force guide" for supporting operators to perform precise manipulation by using a master-slave robot. The virtual fixture for precise and safety surgery was implemented on the system to demonstrate an idea of high-level collaboration between a surgical robot and a navigation system. The extension of virtual fixture is not a part of the Open Core Control system, however, the function such as virtual fixture cannot be realized without a tight collaboration between cutting-edge medical devices. By using the virtual fixture, operators can pre-define an accessible area on the navigation system, and the area information can be transferred to the robot. In this manner, the surgical console generates the reflection force when the operator tries to get out from the pre-defined accessible area during surgery. The Open Core Control software was implemented on a surgical master-slave robot and stable operation was observed in a motion test. The tip of the surgical robot was displayed on a navigation system by connecting the surgical robot with a 3D position sensor through the OpenIGTLink. The accessible area was pre-defined before the operation, and the virtual fixture was displayed as a "force guide" on the surgical console. In addition, the system showed stable performance in a duration test with network disturbance. In this paper, a design of the Open Core Control software for surgical robots and the implementation of virtual fixture were described. The Open Core Control software was implemented on a surgical robot system and showed stable performance in high-level collaboration works. The Open Core Control software is developed to be a widely used platform of surgical robots. Safety issues are essential for control software of these complex medical devices. It is important to follow the global specifications such as a FDA requirement "General Principles of Software Validation" or IEC62304. For following these regulations, it is important to develop a self-test environment. Therefore, a test environment is now under development to test various interference in operation room such as a noise of electric knife by considering safety and test environment regulations such as ISO13849 and IEC60508. The Open Core Control software is currently being developed software in open-source manner and available on the Internet. A communization of software interface is becoming a major trend in this field. Based on this perspective, the Open Core Control software can be expected to bring contributions in this field.

Software is now a crucial component of every product as technology continues to develop all elements of health care. It is widely integrated into digital platforms for both medical and non-medical uses. One of three forms of software connected to medical devices is software that, on its own, qualifies as a medical device. This article intends to provide an analysis and summary of recent research in the field of medical device development methodology, explore these investigations’ phases, and assess the risk and legal implications. The literature search was carried out to find peer-reviewed articles on content released between 2010 and 2021 in Scopus, Web of Science, and Science Direct. based on criteria for inclusion and exclusion. Given the distinctive characteristics of software as a medical device (SaMD) that go beyond those of conventional medical hardware or devices, regulators across the globe started to realize the need to consent to a framework and set of guiding principles for the industry. This will allow all stakeholders, including regulated entities, to advance safe innovation and safeguard patient safety. From the time a product is first conceptualized until it is launched onto the market, the development of software as a medical device is incredibly complicated and greatly relies on the use of good manufacturing practices. The key issues that must be addressed in the future are the transparency of regulatory processes throughout the globe.

While computer-related failures are known to play a significant role in deaths and injuries involving medical devices reported to the U.S. Food and Drug Administration (FDA),1 there is no similar reporting system that meaningfully captures security-related failures in medical devices.Medical device software must satisfy system properties, including safety, security, reliability, resilience, and robustness, among others. This column focuses on the challenges to satisfying a security property for medical devices: post-market surveillance, integrity and availability, and regulation and standards.Medical devices depend on software for patient care ranging from radiation therapy planning to pharmaceutical compounding to automated diagnosis of disease with mobile medical apps. Meanwhile, the medical community has observed an uptick in reported security vulnerabilities in medical device software—raising doubts of cybersecurity preparedness. It should come as little surprise that security risks in medical devices "could lead to patient harm" as recently explained by the chief scientist at the FDA Center for Devices and Radiological Health.2 Device manufacturers and healthcare providers ought to more carefully and deliberately consider security hazards during the phases from design to use of medical devices.Between years 2006 and 2011, 5,294 recalls and approximately 1.2 million adverse events of medical devices were reported to the FDA's Manufacturer and User Facility Device Experience (MAUDE) database.1 Almost 23% of these recalls were due to computer-related failures, of which approximately 94% presented medium to high risk of severe health consequences (such as serious injury or death) to patients.1 For security incidents on medical devices, no systematic national reporting system exists.3 Yet, individual hospitals know of hundreds of security incidents on medical devices.2For instance, the FDA MAUDE does not capture adverse events such as lack of or impaired availability of function when malware infects a medical device's operating system. FDA's own disclaimer explains that the MAUDE database is qualitative rather than quantitative. MAUDE is incomplete with underreporting and reporting bias.Imagine the reaction of a clinician using a high-risk pregnancy monitor that begins to perform more slowly because of a Conficker infection. Would the clinician report a malware infection? Likely not. Admitting to playing a role in accidentally infecting a medical device-would likely lead to consequences ranging from disciplinary action to loss of reputation. Thus, the actual incidence of security failures leading to healthcare delivery failures may be significantly greater than the available statistics suggest. To have a better understanding of medical device security, the bad-news diode must be shorted. Reporting must be incentivized rather than penalized.If you watch television crime dramas, you may be duped into thinking that hacking of medical devices is the number-one risk for public health today. You would be wrong. The most pressing risks are much less sexy: the unavailability of patient care and the lack of health data integrity. Here, we highlight a few examples that illustrate the consequences of unavailability and lack of integrity.Interventional radiology suites and cardiac catheterization labs contain a number of computer systems to perform time-sensitive cardiac procedures, such as angioplasty, to open blocked arteries for improved outcomes in patients suffering acute heart attacks or strokes.According to The Wall Street Journal,2 a Department of Veterans Affairs (VA) catheterization laboratory in New Jersey was temporarily closed in January 2010. Malware had infected the computer systems. The consequence? Patients do not receive the safe and effective care they deserve when malware causes unavailability of care. The VA has experienced hundreds of malware infections in medical devices such as X-ray machines and lab equipment made by well-known, reputable companies.Conficker was detected on 104 devices at the James A. Haley Veterans Hospital in Tampa.2 The affected devices included an X-ray machine, mammography, and a gamma camera for nuclear medicine studies. Conficker is a relatively old piece of malware with well-known mitigation strategies. Why does old malware persist on medical devices?We observe that one of the cultural challenges to improved cybersecurity and t herefore safety and effectiveness is a lifecycle mismatch. For instance, operating system software with production lifecycles measured in months does not match well with a medical device having production lifecycles measured in years or decades. The equivalent of a transformer for impedance matching does not yet exist for safely connecting these different production cultures.Risks of depending on unsupported software has parallels to depending on a device where parts are no longer manufactured or repaired. Medical devices still rely on the original versions of Windows XP (circa 2001). In October 2012, the Beth Israel Deaconess Medical Center in Boston reported to the NIST Information Security and Privacy Advisory Board that the hospital depends on 664 Windows-based medical devices primarily because of supply chain issues. Of the 664 computers, 600 devices run the original version of Windows XP. There are no Service Pack 1 (SP1) machines, but there are 15 SP2 machines and 1 SP3 machine. One MRI machine still runs Windows 95. Security support for SP1, SP2, and SP3 ended on October 10, 2006, July 13, 2010, and April 14, 2014, respectively. In many cases, a medical device manufacturer does not provide an effective way for hospitals to upgrade to supported versions of operating systems. Today, healthcare providers are told to maintain a secure system from insecure devices.4A medical device infected with malware can stray from its expected behavior. For instance, malware can cause a device to slow down and miss critical interrupts. When this happened on a high-risk pregnancy monitor, healthcare professionals could no longer trust the integrity of the sensor readings and depended on backup methods.5Antivirus software can help mitigate certain cybersecurity risks, but they also introduce their own risks. On April 21, 2010, a third of the hospitals in Rhode Island were forced to "postpone elective surgeries and stop treating patients without traumas in emergency rooms" because an automated antivirus software update had accidentally misclassified a critical Windows DLL as malicious. The problem with antivirus software is that by definition, antivirus software is a postmarket afterthought to make up for design flaws in the device. Antivirus software does not remove the need to incorporate security into the early design of medical devices.According to the FDA mission statement, the agency holds responsibility for protecting public health by assuring the safety, efficacy, and security of medical devices. In June of this year, the FDA issued draft guidance on cybersecurity6 and gave examples of what FDA reviewers would expect to see during premarket review. The draft guidance intentionally does not prescribe any particular approach or technology but instead recommends that manufacturers consider cybersecurity starting at the concept phase of the medical device.The FDA recommends that manufacturers provide:Standards bodies are taking actions to improve medical device cybersecurity. For instance, the Association for the Advancement of Medical Instrumentation (AAMI) recently formed a working group on medical device security that includes engineers from manufacturing and regulators. AAMI has already released standards specific to network-related cybersecurity risks (ANSI/AAMI/IEC-80001). International harmonization of cybersecurity guidance is likely on the horizon, given that phrases such as "security patches" appear in proposals from the International Medical Device Regulators Forum.Modern healthcare delivery depends on medical device software to help patients lead more normal and healthy lives. Medical device security problems are real, but the focus on hacking goes only skin deep. Consequences of diminished integrity and availability caused by untargeted malware include the inability to deliver timely and effective patient care. By addressing security and privacy risks at the concept phase, medical devices can remain safe and effective despite the cybersecurity threats endemic to computing. Security of medical devices is more than just a potential problem on the horizon.This work was supported in part by NFS CNS-1331652 and HHS 90TR0003/01. Any opinions, findings, and conclusions expressed in this material are those of the authors and do not necessarily reflect the views of NSF or HHS.

Cybersecurity vulnerabilities of cardiac implantable electronic devices: Communication strategies for clinicians—Proceedings of the Heart Rhythm Society's Leadership Summit

In the European Union (EU), medical devices (MD) industry is a representative employer, with the MD sales accounting for EUR 100 billion. This chapter presents the classification and give some examples of MD in EU and describes and analyzes all safety alerts on MD of a member state of EU in 2017. International laws were used to define MD. Examples and safety alerts of MD of the Portuguese medicine agency were considered. MD are not medicines, but they have a medicinal application. MD are classified in Classes I-III. Only 32 safety alerts were identified in Portugal, none related to serious adverse events, and 6 related to devices voluntarily withdrawal from the market, for example, counterfeit products. The concept of MD is clearly defined in regulations. Although alerts on MD are limited, falsified products were identified in EU market, which is extremely regulated. For instance, future development of safety, traceable, and economic devices is very important to assure, patients' safety and access.

Products with high efficacy and low cost are desirable in all market sectors and environments, particularly in settings where resources are limited. The health sectors of developing nations are an example of this basic economic principle as constrained financial and human resources must be budgeted toward large (and often, growing) populations’ health needs. However, the cost and quality characteristics that are absolutely necessary in resource-limited settings (RLS) remain highly desirable in wealthy markets as well. Consequently, technologies and strategies designed in RLS are frequently adopted by high-income nations, a process termed “reverse innovation” [1-4]. In recent years, some medical and surgical devices designed for RLS have been adopted by high-income nations. These reverse innovations have simultaneously overcome historical barriers to medical device deployment in RLS and challenged previously held assumptions regarding the direction of information transfer between high- and low-income nations. The potential for reverse innovation has subsequently been proposed as a reason in and of itself to develop products for RLS [4]. Products that result in reverse innovation offer improved care quality and treatment outcomes at lower costs to health care systems, expand markets for manufacturers, promote bidirectional transfer of information, and strengthen global partnerships for health equity [1-4]. One country that has made investments in myriad health innovations is Rwanda, a landlocked East African nation of approximately 12 million. Within the past two decades, Rwanda’s limited resources and diverse health care needs have combined to produce health care innovations ranging from community-based service delivery pathways to novel vaccine roll-out strategies [5-10]. Rwanda’s innovative approaches to seemingly insurmountable health challenges, and the nation’s resounding successes in these initiatives, have been described in a previous article in this Globalization and Health special series [2]. In the present article, we describe our experience with medical device innovation in Rwanda through two case studies, highlighting approaches taken to accelerate development and facilitate bidirectional flow of information. We also discuss ongoing challenges to progress in the field of health technology innovation for RLS. In sharing our experiences, we add our voices to the call for health technology innovation for low- and middle-income countries (LMICs).

Cloud computing and its related virtualization technologies have become one of dominant trends to deploy software, compute difficult problems, store different types of data, and stream real-time video and audio. Due to its benefits from cost-efficiency and scalability to maintain server solutions, many organizations are migrating their server applications running on physical servers to virtual servers in cloud computing infrastructures. Moreover, cloud computing has enabled mobile and battery-powered devices to operate without strong processing power and large storage capacity. However, it is not trivial to use this trendy technology for medical Cyber Physical Systems (CPSs) which require processing tasks’ requests to send instructions to the local actuator within specified deadlines. Since a medical CPS device monitoring a patient’s vital signs may not have a second chance to recover from an erroneous state, achieving cost-efficiency with higher resource utilization in cloud computing may not be the ultimate goal to configure the healthcare IT infrastructure with medical CPS devices. In this paper, we focus on private cloud infrastructures with the fair resource sharing mechanism in order to run medical CPS applications. First, we introduce our medical CPS device model used for designing our cloud infrastructure following the Integrated Clinical Environment (ICE) standard developed by the Medical Device Plug-and-Play (MDPnP) project. Second, we investigate limitations to deploy CPS applications using existing auto-scaling mechanisms. Finally, we propose our novel middleware with a virtual resource sharing mechanism inspired by autonomic computing, and present its performance evaluation results simulated in the OpenStack private cloud.

Annex G of ISO 10993-11:2017 lists 24 substances that are allegedly material-mediated pyrogens (MMPs) in medical devices and recommends using the rabbit pyrogen test (RPT) for MMP evaluation. We aimed to establish whether medical devices contain MMPs; determine if MMPs are pyrogens or uncouplers of oxidative phosphorylation (UOPs); complete a survey of RPT failures; and develop a UOP screening list. A literature search was conducted to identify MMPs associated with medical devices. Concurrently, data mining was conducted to search for MMPs in medical device extractables databases and collect RPT data from industry and contract research labs. The literature search produced the conclusions: (1) Annex G’s endogenous biological compounds are pyrogenic; (2) Annex G’s drugs and UOP substances are not pyrogenic but thermogenic; (3) numerous other UOPs were identified; and (4) nearly all UOPs are poorly soluble in saline (the RPT’s injection solvent). The data mining found two Annex G MMPs in medical device extracts that were not pyrogenic and confirmed that the RPT failure rate was low, with investigated failures caused by endotoxin or test incompatibilities, not by Annex G MMPs. Since no pyrogenic Annex G MMPs or saline soluble UOPs were found in medical device extracts, the RPT is unnecessary. If UOPs are detected during chemical characterization studies, an ISO 10993-17:2023 toxicological risk assessment can be used to determine their hazard potential. Residual biological contamination can be evaluated with the human monocyte activation test, which detects all biological pyrogens. The term “MMP” is inaccurate and obsolete. Plain language summary Pyrogens cause fevers in mammals. Medical devices contaminated with bacterial components or chemicals generate a material-mediated pyrogenic (MMP) response. The rabbit pyrogen test (RPT) is used to detect MMPs even though its accuracy is questionable. An international standard lists 24 chemicals that are alleged to be medical device MMPs. To evaluate this belief, a search of the scientific literature was conducted to identify MMPs associated with medical devices along with a data mining effort that searched for MMPs found by chemistry laboratories that test medical devices. Failure rates for the RPT were also studied. Only two of the 24 chemicals were found in medical devices, and they were not pyrogens, plus the RPT failures were not due to MMPs. It was concluded that MMPs do not exist and therefore the RPT could be replaced with a human blood cell test that detects all types of biological pyrogens.

This chapter focuses on emerging opportunities and related challenges associated with medical device development. In a rapidly changing healthcare environment and related support structure, it has become essential to develop products and technologies that are not only innovative and affordable, but at the same time, safe and reliable for long-term performance stability. With the advancement of efficient computational platforms and artificial intelligence, newer opportunities in the form of software-driven medical devices and robotic minimally invasive surgical systems have emerged as key thrust areas in medical device manufacturing sector. A lot of research outcomes are being reported worldwide for development of haptic feedback-based robotic manipulators for complex surgical procedures. Leading industry manufacturers are focusing on transdisciplinary synergetic research for faster product development and subsequent market deployment. However, such medical cyber-physical systems have also brought out the need for ensuring product safety and data security for uncompromised privacy and process integrity. There are other challenges related to validation, certification and regulations of healthcare-related mobile applications and software-driven diagnostic and therapeutic tools which need to be handled with highest priority for patient safety. The chapter focuses on the AI-powered and software-driven medical devices as well as various technologies of robotic surgery and the associated research opportunities and challenges in these domains.KeywordsSoftware-driven medical devicesRoboticsMedical regulationsMedical cyber-physical systemsValidation

PMD68 - HEALTH PLAN COVERAGE FOR MEDICAL DEVICES AND THE USE OF ELECTRONIC MEDICAL RECORD SYSTEMS

The computerization of medicine opens up wide opportunities not only for providing assistance, but also for intruders. The violation of digital control of medical devices can lead not only to data leakage, but also to a threat to human health and life. The diversity and specificity of medical cyber-physical devices makes it difficult to protect them and consider the threat landscape. The purpose of this work is to systematize attacks on medical systems. The authors highlight the features of medical cyber-physical systems (MCPS), consider a set of typical attacks. The authors have identified both common attacks for various CPS, and specialized attacks aimed at medical devices and systems. The paper analyzes the existing systematization as well. The authors present a developed new systematization of attacks on a wide range of features, which is distinguished by the completeness and highlighting of all important attack aspects from the point of view of the medical field.

With the rapid development of the medical device against COVID-19 is an excellent achievement. There are numerous obstacles effectively facing the worldwide population, from manufacture to distribution, deployment and, acceptance. Many manufacturers have entered the market rivalry as people's knowledge and demand for home-use medical equipment has increased. India represents a compelling market opportunity for global medical device manufacturers. Substantial growth for the Indian medical device industry is expected to be driven by the current low per-person spending rate for medical devices. The growth of the medical devices industry in India raises competition law issues (anti-trust) and therefore maintaining public trust in home-use medical devices during COVID-19 will be as essential. The review article aims to create awareness among people about commonly used medical devices during the COVID-19 pandemic and to survey people’s trust in home usable medical devices in India. In a worldwide pandemic, manufacturers of medical devices face insufficient storage and the impossibility of meeting the requirements of the health centre. The sale of some of the most significant medical devices has increased, making it more difficult for the medical device industry to satisfy demand with high-quality goods since the quality of COVID-19 items plays a vital part in the present scenario. Despite the difficulty in providing enough medical equipment during a pandemic, they are striving to adapt to the circumstance. After recognizing the need to promote awareness and grasp the selling, and production, handling of medical instruments during COVID-19 at home was conducted. In addition, medical equipment manufacturers and distributors look at this scenario as an opportunity to profit more. This review article would enable researchers during COVID-19 to build more knowledge and widespread trust in medical technologies respectively.

: There has been an upsurge in the number, diversity, and intricacy of medical devices in last two decades. Regulation of these devices has also advanced due to the requirement for a steady regulatory perspective. Various regulations of medical devices across major economies of the world were reviewed and then other pertinent issues of medical device regulations were discussed. The regulatory guidelines for medical devices in various countries which include United States, Europe, Japan, India, Brazil Japan, Australia etc. were reviewed. The need for harmonization of the device regulations and other regulatory issues were also assessed. Since the early 1980s, the regulatory paradigm for medical devices has changed exceptionally. Currently there are many countries which have enforced medical device regulations. Now with the availability of different regulations of the countries or region on medical devices, there is a need to harmonize regulations in order to curtail regulatory hurdles and expedite access to high quality, safe and efficacious medical devices. Most countries are trying to harmonize the regulatory guidelines for medical devices through their participation in Global Harmonization Task Force (GHTF). Harmonized regulation of medical device will lead to the availability of quality product.Key words: Medical device, Medical device recalls, Food drug and cosmetic act, Clinical trial, Humanitarian device exemption.