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Development of a Comprehensive Regulatory Model for Medical Devices

Manvendra S. Teli^1,*, Vikas Jhawat¹ and Anil Kumar Sharma²

¹School of Medical and Allied Science, GD Goenka University, Gurugram, Haryana, India

²Regulation Bureau AICTE, New Delhi, India

*Correspondence to: Manvendra S. Teli, Research Scholar, School of Medical and Allied Science, GD Goenka University, Gurugram, Haryana, India. E-mail: telimanvendra@gmail.com

Received: June 1 2024; Revised: July 10 2024; Accepted: July 29 2024; Published Online: October 9 2024

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Cite this paper:

Manvendra S. Teli, Vikas Jhawat and Anil Kumar Sharma. Development of a Comprehensive Regulatory Model for Medical Devices. BIO Integration 2024; 5: e972.

DOI: 10.15212/bioi-2024-0030. Available at: https://bio-integration.org/

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© 2024 The Authors. This is an open access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/). See https://bio-integration.org/copyright-and-permissions/

Abstract

Background: The development of a comprehensive regulatory model for medical devices is essential to ensure the safety, efficacy, and quality of medical devices throughout their lifecycle, from design and development to post-market surveillance. This paper outlines a robust framework for such a regulatory model, detailing key components and processes necessary for effective regulation.

Methods: The data and literature were collected from various databases including Springer, Science Direct, Taylor and Francis, Wiley, Bentham Science, and websites of different regulatory agencies. The collected data were utilized in the research work to formulate the new regulatory model.

Results: Different guidelines represent acceptable regulatory practices for all medical items. There are four risk classification levels of the medical devices (class I–IV, based on the risk level). For every country, the regulatory requirements are different. Global regulations for medical device approval are essential to guaranteeing their quality, safety, efficacy, and performance before they can be put on the market to safeguard, prevent, enhance, and maintain public health. Different classes have different regulatory steps for approval of the devices, which varies from region to region. The World Health Organization’s Department of Essential Health Technologies’ Diagnostic Imaging and Medical Devices team has developed and implemented the Baseline Country Survey on Medical Devices. The proposed model includes the establishment of a clear legislative and regulatory framework, featuring a risk-based classification system aligned with international standards. It emphasizes rigorous pre-market requirements, including design controls, clinical evaluation, quality management systems, and technical documentation. Market authorization processes are described, highlighting pathways such as Premarket Notification (510(k)), Premarket Approval (PMA), and De Novo Classification, supported by thorough scientific review and expert advisory panels. The present study is all about the global requirements of the regulation of the medical devices and it was concluded that overall, a global comprehensive regulatory model for medical devices aims to strike a balance between ensuring patient safety, facilitating innovation, and enabling timely access to life-saving medical technologies around the world.

Conclusion: The model advocates for international harmonization and collaboration, promoting regulatory convergence and the adoption of global standards. It also supports innovation through accelerated approval pathways and regulatory sandboxes, alongside continuous improvement driven by regulatory science research and stakeholder engagement. By integrating these elements, the comprehensive regulatory model aims to protect public health while fostering medical device innovation and ensuring global regulatory compatibility.

Keywords

Medical devices, post-marketing surveillance, regulations for medical devices, regulatory model.

Introduction

Medical devices include a wide array of instruments, machines, implants, and software that are used for diagnosing, treating, monitoring, and preventing diseases and conditions. Medical devices have an important role in modern healthcare by helping healthcare professionals deliver effective care and improve patient outcomes. Human resources and health technologies are essential to current health systems. Medical devices are an element of health technology that give healthcare professionals the tools needed to carry out duties effectively and efficiently. There are different types of medical devices, such as diagnostic devices, that are used to identify diseases, conditions, or infections. Examples of diagnostic devices include MRI machines, X-ray machines, ultrasound scanners, blood glucose meters, and diagnostic test kits. It is intended that medical disorders will be treated or alleviated by therapeutic devices, which can range from simple devices (bandages and splints) to complex devices (pacemakers, insulin pumps, and prosthetic limbs). Monitoring devices are used to track vital signs, physiologic parameters, and disease progression. Examples of monitoring devices include blood pressure monitors, heart rate monitors, pulse oximeters, electrocardiogram machines, and continuous glucose monitors. Surgical instruments are used by surgeons during surgical procedures. Surgical instruments include scalpels, forceps, retractors, surgical lasers, and robotic surgical systems. Implantable medical devices are used to repair damaged organs or sustain biological structures within the body. Examples of implantable medical devices include cardiac pacemakers, artificial joints, cochlear implants, and intraocular lenses. To guarantee the safety, effectiveness, and quality of medical devices, regulatory agencies, including the European Medicines Agency (EMA) in Europe and the Food and Drug Administration (FDA) in the United States, strictly control the development, production, and marketing of these products. The classification and approval process for medical devices vary depending on factors, such as risk level, intended use, and technological complexity [1, 2].

Methodology

The methodology for developing the comprehensive regulatory model for medical devices involved a multi-phase approach integrating qualitative and quantitative research methods. Initially, an extensive literature review was performed to analyse existing regulatory frameworks and guidelines across major global regulatory bodies, including the FDA, EMA, and World Health Organization (WHO). The data were searched from various search engines, including Springer, Science Direct, Taylor and Francis, Wiley, and Pubmed, using the following keywords: regulatory model; medical devices; regulations for medical devices; and post-marketing surveillance. This literature review helped identify key components and best practices in current regulatory processes, as well as gaps and challenges that need to be addressed. A comparative analysis of regulatory requirements and approval pathways for different risk classifications (classes I, II, III, and IV) was subsequently performed to clarify the variations and commonalities in regulatory practices across different regions. The findings from these analyses were synthesized to develop a draft model. The final model incorporates rigorous pre-market requirements, post-market surveillance strategies, and pathways for accelerated approval, which ensures a balanced approach to safety, efficacy, and innovation. The entire process was iterative with continuous refinement and emerging regulatory science research, which facilitated the robustness and applicability of the proposed model in diverse regulatory environments.

Data supporting the need for developing a new model for medical devices

Despite the diligent efforts of regulatory bodies worldwide, several loopholes persist in the medical device regulatory process [3–7]. In the USA, manufacturers can exploit FDA regulations by using previously approved but recalled devices as predicates to obtain approval for new devices without conducting clinical testing. This loophole has led to the approval and subsequent recall of numerous unsafe devices. While new regulations aim to close past loopholes in Europe, the transition period and complex requirements for class III and implanted devices pose challenges. Additionally, the need for independently generated clinical evidence could create access issues. The regulatory system in Australia faces potential loopholes, including misclassified devices bypassing stricter evaluations, differences in international standards, limited clinical data requirements, and the rapid pace of technological advancements outpacing regulatory updates. The regulatory framework in India has gaps in post-market surveillance and enforcement, which leads to delays in identifying safety issues and potential exploitation of regulatory weaknesses by manufacturers. The regulatory environment in Japan, while proactive in addressing gaps, emphasizes the need for evidence-based assessments, rigorous clinical testing, routine audits, and continuous regulatory system improvements to close loopholes effectively. Singapore highlights the importance of precise device classification, robust post-market surveillance, and transparency in the regulatory process to prevent devices from entering the market with insufficient oversight. Each of these geographic regions, while striving to ensure the safety and efficacy of medical devices, must address the specific loopholes to enhance the overall effectiveness of thei regulatory systems and protect public health more effectively [3–7].

Principals of good regulatory practice

Different guidelines represent acceptable regulatory practise for all medical items. Different principles for good regulatory practice are in place at the political level to adopt comprehensive programmes for regulatory change that include precise goals and execution structures. Efficient, transparent, and non-discriminatory application of all regulations and regulatory processes are assured. The scope, efficacy, and enforcement of competition policy are reviewed and improved as necessary. Enhanced international accords are implemented to reinforce international principles and pointless regulatory impediments to trade and investment are removed [8, 9].

The four medical equipment risk classification levels are shown in Table 1.

Regulatory requirement for medical devices

Global regulations for medical device approval are essential to guaranteeing quality, safety, efficacy, and performance before the medical device can be put on the market to safeguard, prevent, enhance, and maintain public health. In the end, this increases the customer’s trust and confidence in the product and the maker. The devices are divided into distinct classes according to the degree of risk the device poses. Thus, the regulatory processes for approving the devices in each class change depending on the location. Regulatory procedures vary between locations and application filing fees vary as well [10, 11].

Loopholes in regulatory processes for all countries

USA: According to a Yale-led study, manufacturers are able to circumvent federal law and use a risky medical equipment as justification for receiving approval from the FDA to market additional, related products. The FDA bases most approvals of medical devices on how similar the products are to medical devices that are already on the market and manufacturers often rely on earlier FDA clearances to avoid doing clinical testing. According to a recent study, some medical devices that have been recalled are still offered because the devices function like other items. Products are included that were the subject of a class 1 recall and an FDA warning that using the device could cause harm to patients or even death. Prior research has identified cases of major patient injury brought on by gadgets that were approved despite having flaws. Investigators found that 44% of recalled devices were connected to earlier devices that had previously been the subject of class 1 recalls. This finding means that before the FDA approved the new generation of devices, an estimated 1 in 4 of these older devices were recalled. Furthermore, these new devices frequently assisted in the authorization of extra devices that were subsequently recalled. It is possible that many patients and medical professionals are not aware that FDA rules allow new devices to use recalled predicates [3].

Europe: The new regulations aim to upgrade the existing system and adequately close any loopholes from the past by bringing in a number of very significant enhancements. The ideas are presented as a regulation. Unlike directives that must be transposed by national legislatures, regulations are immediately enforceable and the parties involved are responsible under European Union law. Regulations are thought to be the right legal instrument because regulations establish precise, definite norms that will be uniformly applicable at the same time across the entire European Union. Additionally, because the Active Implantable Device Directive and Medical Device Directive were historically governed by two different legal documents, the new regulations will take effect 3 years after publication in the case of the medical device regulation and 5 years after publication in the case of in vitro diagnostic device regulation, even though the directives are currently enforceable by law. Under the Medical Device Regulation, the substantive requirements and conformity evaluation processes are more onerous and complicated. For class III and implanted medical devices, for example, the updated text calls for more stringent clinical evidence. The phrase “sufficient clinical evidence” only applies to clinical data generated independently by the manufacturer or by a rival manufacturer. In the latter case, access to the clinical data requires a contract. “Sufficient clinical evidence” refers only to clinical data generated independently by the company or by a rival company [4].

Australia: The problem was addressed using a variety of strategies and choices after extensive consultation over a long period of time. Loopholes could arise if devices are misclassified into lower-risk categories, allowing the devices to bypass stricter evaluation processes. If the system for monitoring and reporting adverse events or safety issues lacks robustness, potential problems might not be identified in a timely manner, putting patients at risk. If the regulatory standards of other countries are significantly different from the regulatory standards in Australia, loopholes could arise if devices approved elsewhere are considered equivalent without comprehensive evaluation. If medical devices are approved based on limited clinical data or if clinical trials are not required for some device categories, loopholes could be created in which devices are cleared without sufficient evidence of safety and effectiveness. Rapid technological advances might lead to regulatory gaps if the existing regulations are not updated to accommodate novel medical technologies. If third-party organizations are involved in reviewing and assessing medical devices, there is a potential for variations in the evaluation processes and potential conflicts of interest. If enforcement mechanisms and penalties for non-compliance are not appropriately stringent, manufacturers might be more inclined to exploit regulatory gaps even if strong regulations are in place [5].

India: Gaps in the post-market surveillance system could lead to delays in identifying and addressing safety issues or adverse events related to medical devices. If manufacturers are not obligated to give thorough data throughout the regulatory review process, loopholes may appear that may obstruct an accurate assessment by regulatory authorities. If the current framework is not prepared to address the particular difficulties posed by new technologies, regulatory loopholes could develop with the expansion of medical software and digital health solutions. Even with strict restrictions, producers may be able to take advantage of enforcement flaws if there are weak enforcement measures in place and insufficient penalties for non-compliance [6].

Japan: Addressing and closing loopholes in medical device regulations is crucial to ensuring patient safety, maintaining the effectiveness of regulatory oversight, and fostering a trustworthy healthcare environment. The medical device industry stakeholders and regulatory bodies endeavour to find and close these gaps. To accommodate new technological developments, industry breakthroughs, and any gaps that can develop over time, regulatory frameworks should be examined and modified on a regular basis to increase the importance of using evidence-based assessments when approving proposals. Before gaining regulatory clearance or approval, devices need to go through extensive clinical testing to confirm safety and efficacy. Routine audits and inspections of manufacturing facilities are performed to ensure devices are produced in accordance with regulatory standards. Mechanisms for continuous monitoring and improvement of the regulatory system are available to promptly address any new gaps that might emerge. By implementing these measures, regulatory authorities can significantly reduce the likelihood of regulatory loopholes and enhance the overall effectiveness of medical device regulations in safeguarding patient health and well-being [7, 8].

Singapore: It is crucial to ensure the precise and strict classification of medical devices. To avoid misclassifying devices and allowing the medical devices to access the market with insufficient oversight, regulatory authorities should regularly evaluate the classification criteria. To quickly identify and manage adverse occurrences or safety concerns related to medical devices currently on the market, post-market surveillance methods must be improved. The regulatory process is made more transparent by requiring manufacturers to provide thorough information on the effectiveness, safety, and clinical trials of the products. Regulating agencies will be able to perform extensive evaluations as a result [8].

A global comprehensive model for medical devices

Principles of safety and good regulatory practices

Regulations should state that before medical equipment is put on the market, it must be safe and function as intended. A list of Essential Principles for Medical Device Safety and Performance has been established by the Global Harmonization Task Force (GHTF). These rules have been embraced by many countries. It is mandatory for manufacturers to furnish the regulatory authority with evidence demonstrating that the product conforms to the Essential Principles, is safe to use, and functions as intended for the duration of its life when used for the intended purpose as declared by the maker. Implants and electrically powered devices are two examples of medical device categories in which specific Essential Principles are added to the fundamental principles that apply to all medical devices. The general Essential Principles of medical equipment performance and safety are as follows [12–14]: 1) When a medical device is utilised in accordance with its intended purpose and meets the requirements of technical knowledge and user training, the design and production processes should guarantee medical device safety. The medical device does not compromise the user’s health or the patient’s clinical status. 2) To identify known and predictable dangers and reduce dangers in the medical device design, production, and use, the maker should carry out a risk assessment [15, 16].

Nevertheless, the regulatory body may examine the manufacturer’s proof of conformance, as documented in the technical documentation either prior to or following product release onto the market. The medical device regulation will outline the regulatory body level of engagement with various device classes. The regulatory authority may designate one or more conformity assessment bodies (CABs) to help with this work, but the regulatory authority will still be accountable for the judgements made.

Assessing conformity to the Essential Principles

Medical device manufacturers implement systematic controls during device design, development, testing, manufacturing, and distribution phases to assess device quality, safety, and performance. A medical device design, development, testing, manufacturing, and distribution throughout the life cycle of the medical device are all subject to systematic controls that are implemented by the manufacturer, which ultimately defines device quality, safety, and performance. Typically, the manufacturer accomplishes this process by putting a quality management system (QMS) into place. The medical device risk class determines how thoroughly the regulatory body or CAB evaluates the QMS (Table 2).

Enabling conditions for effective regulation of medical devices

To maintain public trust in medical devices, regulations must be effective and efficient based on strong legal and policy principles and excellent regulatory methods.

The WHO created Good Regulation Practices (Guidelines for National Medical Product Regulation Authorities). When creating a new system of medical device regulation or updating an existing system, the main principles outlined therein, which include a legal foundation, consistency, effectiveness, efficiency, impartiality, clarity, transparency, and flexibility, should be followed [17, 18].

Legal requirements

Regulation of medical devices needs a solid legal foundation. Because regulation of medical devices is dependent upon the national constitution as well as the broader national legal and administrative systems that are currently in place inside the nation, approaching the legal basis of such a regulatory system cannot be done using a single method. The law ought to specify the goods that fall under the purview of the regulatory system and list the organisations that are governed by the regulatory system. The regulatory system should create a broad regulation that assures that only safe, appropriate, and functional medical devices can be sold or made available for use inside the jurisdiction. The regulatory authority duties and enforcement powers, which include taking products off the market and levying fines, should be clearly outlined in the legislation. The regulatory authority should set up procedures for the legislative, judicial, and executive arms of government to be held accountable. Coordination with other agencies, including the justice ministry, the police, and the customs authority, should be covered. The tasks and responsibilities of the political component authorities and the central regulatory authority must be clearly defined in nations with decentralised political systems.

The obligations of producers, importers, distributors, and authorised representatives should be outlined in legislation. There should be distinct channels for political monitoring and accountability when a regulatory authority is assigned to an independent administrative body, such as the ministry of health. Additionally, the legislative framework needs to permit discretion in administration and enforcement, which will enable the regulatory body to implement the “reliance” and “recognition” concepts. As experience is gathered if resources allow, the law should permit the transition from basic to increased regulatory constraints. Additionally, the law should give the regulatory body the capacity to react appropriately and promptly to public health emergencies. Good regulatory processes include giving the public a chance to provide and evaluate insightful feedback on proposals, evaluating the effects of regulations, allowing for appropriate transition times, and establishing standards. The authority should follow these guidelines. Legislative, regulatory, and policy requirements must to be internally consistent, transparent, and predictable [19].

Gap analysis of existing controls

Early evaluation of regulatory restrictions that are in place and pertain to medical devices is crucial. This will enable the decision-maker to comprehend the actions and resources required to establish regulatory capability, as well as meet national public health goals. Gap analysis can be used to assess how closely national legislation conforms to international recommendations and best practices. The authorities should carry out a gap analysis and consult with relevant stakeholders, such as representatives of the patients. The assessment findings will help determine which projects should be implemented first. For example, controls may be more appropriate to prioritise than manufacturing controls in a nation with low or no domestic output, or manufacturing controls may be more appropriate in a nation with a high prevalence of sexually transmitted diseases. It may be prudent to prioritise regulatory actions for medical devices that are used in the diagnosis, treatment, and prevention of specific diseases.

Implementation plan

Following the adoption of national medical device legislation, the designated regulatory body must create and release an implementation strategy. The strategy will be guided by the goals and requirements of public health, as well as the resources that are available, such as qualified personnel, who can carry out legislation.

The schedule should allot time for raising public awareness by creating draft proposals for rules and acquiring input from interested parties. It is important to establish appropriate transition times so that businesses can meet any updated or new regulations. The strategy should also specify how medical devices that are currently being used, distributed, or on the market will be managed. To make sure those producers, importers, distributors, and buyers of medical devices are aware of their obligations, the regulatory body should host meetings and issue guidelines [18].

Monitoring implementation

Goals and performance indicators should be set at the time the regulatory implementation plan is developed so that implementation success can be evaluated against a baseline that reflects the state of medical device regulation at the time. Reports on the legislative body and parliament progress towards those objectives should be made public. Political accountability and transparency will benefit from these reports. The reports could also be applied to assess resource utilisation and adequacy. The regulatory framework implementation timeline may be adjusted based on the progress made. It might be useful to add performance measurements, such as prompt response by the authority in monitoring, if controls with expanded levels are developed. More broad performance audits may include periodic discussions with interested parties, such as industry, patient advocacy groups, and users of medical devices. Ultimately, the general public and legislators will want to confirm that the confidence in the regulatory authority and resource utilisation is justified [20].

Regulatory authority

To carry out the medical device law, a national regulatory agency (NRA) must be appointed that possesses the authority to make autonomous decisions within the regulatory framework. This regulatory organisation could be an independent administrative organisation reporting to a ministry or it could be a part of an already existing government department, such as the Ministry of Health. It is necessary to specify authority governance, as well as the proper checks and balances and a demand for the publication of regular public performance reports. When the legislation or decree of a nation only consists of statutes that define general rules and guidelines, the regulatory body must be granted the power to pass additional legislation. Additionally, the regulatory body should grant the required enforcement authority.

Regulatory competencies and resources

To regulate medical devices effectively and efficiently, the regulatory authority must have the institutional capacity and the necessary individual knowledge to operate in accordance with sound regulatory procedures. Public health concepts, communication and analytical abilities, information processing, and crisis and intervention skills are among the general qualifications for regulatory professionals. Even in cases in which the regulatory authority accepts or depends upon the regulatory decisions of other jurisdictions, certain abilities are necessary. Essential knowledge of the medical device regulatory system, regulator duties, notions of international standards and harmonisation, and an awareness of a variety of device technologies and the applications are among the other specific competencies.

Establishing a stepwise approach to regulating medical devices

This model suggests creating a medical device regulatory framework using a phased or step-by-step method starting with simple regulations and working up to more extensive regulations. The legal structure needs to be adaptable, sustainable, and able to take into account new developments in clinical procedures, public health requirements, and technological advancements. The foundation of the basic controls will serve as the basis for the improved controls. This model encourages countries to implement the concepts offered in internationally harmonised technical recommendations into the legal frameworks to promote global regulatory convergence and harmonisation. There are three main categories of basic regulatory controls (pre-, post-, and after-market). Pre-market controls are implemented prior to a medical device being placed on the market. By accepting or appreciating the efforts or judgements of another medical device regulatory body, the regulatory body can lessen the workload for regulatory body employees. Post-market controls are under the purview of the NRA so that resources may be allocated. Furthermore, the regulatory authority will obtain an indirect understanding of the regulatory status of goods traded in other nations within the home market [21].

Basic level controls and enforcement

The model suggests that fundamental controls be included in a law pertaining to medical devices that establish import controls, define post-market surveillance requirements, and define the parameters under which a healthcare product may be sold, define the regulatory authority duties, and define the scope of regulation. Post-market operations usually involve a system that responds appropriately to complaints of major adverse events and quality issues related to medical devices (Table 3).

Establish Essential Principles of safety and performance

Prior to being introduced on the market, all medical devices should be proven to be safe, function as intended, and be of high quality for the intended use. This basic condition should be established by legislation. The producer, importer, or authorised agent would have to declare that the device complies with the Essential Principles and be ready to produce proof of this compliance in a timely manner. The regulatory body could take enforcement action if the declaration of conformance was made falsely or not made. Using voluntary, pertinent, and acceptable international standards is the preferred, albeit optional, method by which the maker can show compliance with the Essential Principles [22].

Basic pre-market level controls and enforcement

Medical devices can only be sold if shown to be safe, well-made, and function as intended. For most medical devices to operate safely, the manufacturer must instruct the user on how to install, use, and maintain medical device using the device label.

Establish requirements for labels and labelling

Most medical devices must be used safely so the user must be instructed on how to operate the medical device correctly, and when necessary, how to install and maintain the medical device. This requirement is accomplished using labels, usage instructions, and other labelling, such as information for patients, service manuals, and displays, that also serve to lower the hazards connected with using medical devices. The legislation should stipulate language criteria and mandate that labelling is suitable for the intended user of a device, especially for laypeople. Regulatory bodies are required to provide comprehensive guidelines for labelling and language requirements for medical devices and adequately explain any exceptions to these criteria before imposing regulatory controls. The ability to identify medical gadgets by lot or serial number is another purpose of labelling. This process makes traceability possible, which helps with Financial Sector Conduct Authority (FSCA) and aids in the reporting and examination of unfavourable incidents. The incorporation of a unique, globally harmonised device is a recent development and identification on the label [23].

Prohibit deceptive, misleading, and false advertising

It is advisable to give careful thought to introducing legal restrictions and prohibitions on the promotion and advertising of medical equipment together with clear enforcement mechanisms, in addition to the specifications for medical equipment labelling. To be unambiguous, the regulating body should provide guidelines that clearly state these needs. There are some basic regulatory controls which includes making assertions that are backed up by data. Basic regulatory controls only cover medical devices that have received marketing authorization and adheres to usage guidelines and other information found on product labels and does not make any deceptive or inaccurate claims.

Basic market level controls and enforcement

Many countries depend almost exclusively on imported medical supplies. However, it is not practical for a manufacturer of medical equipment to be present physically or legally in every country. As a result, the legislation ought to mandate that a manufacturer operating outside of the nation in question designate a legitimate agent there.

Importers and distributors

The importer and distributor should be obliged to register by giving the regulatory authority details about the address, the identity, and function of a responsible party, and the manufacturer(s) represented. The medical equipment that is imported or distributed should be labelled appropriately with the required paperwork and adhere to the medical devices law. Medical equipment should be tracked along the portion of the supply chain in which the equipment is directly involved and abide by the guidelines provided by the manufacturer for the handling, storage, transportation, and if necessary, maintenance of medical equipment. If the equipment manufacturer names its importer or distributor to operate as an additional approved representative then each activity needs to be registered separately [24, 25].

Listing of medical devices

The regulatory body should create a requirement and information system for authorised representatives of manufacturers outside of regulatory body purview. The importers and distributors are required to furnish a list of the medical devices placed on the national market and ensure that the information maintained in the device listing system is up to date. The listing should include, among other things, the medical device standard descriptive names. The regulatory body will be able to decide which products are put on the market and by whom if medical devices are listed. The listing of a medical device also allows the regulatory body to contact the gadget manufacturers if a suspected problem arises. When a third-party requests information about medical devices that are lawfully on the market, the regulatory body should be able to deliver the medical device. Listing does not imply or serve as proof of marketing authorization.

Basic post-market level controls

Sometimes medical equipment does not work as expected when used in a clinical setting. This finding could be indicative of possible issues with the distribution, manufacturing, labelling, labelling, or storage. This finding could also be the result of improper maintenance, usage, installation, or selection of the device [18].

Create a method for reporting on vigilance

The regulatory body should set up a mechanism that allows patients, users, and the maker of medical devices to file concerns about those devices directly or through an authorised representative. The regulatory body covers adverse events that occur at the patient and device levels, especially those adverse events that result in death or serious harm. When a patient or end-user notifies the regulatory body of an adverse event, the device manufacturer must be notified through a field safety notice and the investigation and trend analysis of the information, along with potential FSCA. Investigations, trend analyses, and/or potential FSCA or enforcement actions may be sparked by vigilance reports. A patient or end-user should be able to ask the regulatory body to share information about comparable incidents elsewhere with regulatory bodies in other jurisdictions.

Mandatory FSCA producer obligatory notification

The law should mandate that any FSCA a manufacturer undertakes within the nation be reported to the regulating body as soon as possible directly or through an authorised agent. As a regulatory body becomes aware of a newly discovered possible risk connected to a product through its own research or through interactions with other authorities or manufacturers. The regulatory body should have a well-established procedure in place for promptly sending out advisories or alerts regarding FSCAs. Such a system should permit targeting of some individuals, typically after consulting medical experts. Proper action should be taken to safeguard the public health and avoid needless anxiety or confusion on the part of patients or users of medical devices who are not impacted. Communication tools that are suitable for the intended audience should be used that are responsive to the urgency of the activity. The regulatory body should set up procedures for tracking the efficacy of corrective or remedial measures. The regulatory body should respond to questions from the public, medical experts, the media, the government, and foreign authorities and exchange information [18].

Establish a process for sending users safety notifications

The manufacturer normally informs customers of any issues with a medical device directly or through an authorised representative. This model suggests that the regulatory body sets up a process for immediately informing healthcare facilities that utilise the impacted medical devices, as well as other users, of major adverse events and the FSCA through issuance of safety alerts and advisories. The manufacturer or the authorised agent should be consulted wherever possible regarding the alert text, but the regulator has the final input.

Undertake market surveillance

The regulatory body activities concerning the supervision of medical equipment sold domestically are known as market surveillance. Based on a supply risk assessment chain, a review of the complaints and adverse event reports and data from medical device manufacturer and their authorised representative post-market surveillance systems, the regulatory body may carry out specific actions.

Require mandatory reporting of adverse events

The regulatory body should create a statutory requirement for the prompt reporting of adverse occurrences connected to medical devices under the jurisdiction of the regulatory body by the authorised representative or manufacturer to the degree that investigative and information management capabilities permit. The regulatory body should specify the necessary information, the reporting time restrictions, the reporting threshold (i.e., kinds of occurrences that should be reported), and which party or parties are required to report. These standards need to be in line with GHTF recommendations for reporting adverse events [22].

Disposal

When a medical gadget is no longer needed, it must be disposed of properly. These standards need to generally be in line with GHTF recommendations for reporting adverse events [26]. In some instances, it might be imperative to discard a device before ultimate decomposition if verified that is incapable of fulfilling the intended purpose and pose a risk to patients or users. To guarantee that the medical device disposal does not endanger people or the environment, safety precautions must be followed. This is particularly crucial for tainted equipment, such as hypodermic needles and syringes, as well as equipment that contains radioactive, poisonous, or contagious elements. As appropriate for the type of device, instructions for use and labelling on medical devices should include information on how to properly dispose of the equipment once the useful life has ended. When substandard and falsified (SF) medical goods are detected, the regulatory body is required to record a local disposal process. This will guarantee that goods of this kind, which are fake or forged, are not shipped to another nation where the goods could endanger people. Decontamination and appropriate waste management procedures in accordance with the manufacturer’s instructions should be mandated for disposable equipment. Based on the manufacturer’s suggestions, the applicable regulatory authority should create replacement and decommissioning standards in collaboration with other relevant governmental authorities. For complex and high-tech products in particular, user and manufacturer consultation is essential to determine the optimum disposal strategy [22].

Discussion

The originality and innovation of the proposed regulatory model for medical devices was emphasized herein. The model is not merely a reiteration of existing frameworks but represents a significant advance through a comprehensive and integrative approach to life cycle management and safety. Unlike traditional models, this proposed framework uniquely combines rigorous pre-market requirements with post-market surveillance, offering a seamless continuum that enhances safety and innovation [5]. The model introduces novel elements, such as the integration of regulatory sandboxes and accelerated approval pathways, which are designed to foster innovation while maintaining stringent safety standards. Furthermore, the model emphasizes international harmonization and regulatory convergence, addressing the critical issue of disparate regulatory requirements across regions, which is a significant gap in current practices.

The development of a comprehensive regulatory model for medical devices is a critical step toward ensuring the safety, efficacy, and quality of these devices throughout the life cycle [7]. The current overview has highlighted the complexities and challenges faced by different regions in the regulatory frameworks, underscoring the need for a unified global approach. In the USA the reliance on predicate devices for FDA approval has revealed significant loopholes, allowing potentially unsafe devices to enter the market. Stringent new regulations in Europe, while promising, require time and adaptation to effectively address gaps, especially with respect to clinical evidence requirements. The regulatory system in Australia must continuously adapt to technological advances and ensure robust post-market surveillance to prevent misclassification and oversight. India faces substantial challenges in enforcement and post-market surveillance, which are critical for identifying and mitigating safety issues promptly [6]. Proactive measures in Japan include continuous improvement and evidence-based assessments that serve as a model for effectively addressing regulatory gaps [7]. The emphasis on precise classification, transparency, and rigorous post-market surveillance in Singapore further exemplifies best practices in medical device regulation [8].

The proposed global regulatory model advocates for international harmonization and collaboration emphasizes adoption of global standards to ensure consistency and interoperability across different jurisdictions. By implementing a risk-based classification system, rigorous pre-market requirements, and robust post-market surveillance mechanisms, the model aims to balance patient safety with innovation. The inclusion of accelerated approval pathways and regulatory sandboxes encourages the development of cutting-edge medical technologies, while maintaining stringent safety standards. Continuous improvement driven by regulatory science research and stakeholder engagement is crucial for adapting to emerging challenges and technological advancements.

Ultimately, this comprehensive regulatory model strives to protect public health by fostering a collaborative global regulatory environment that ensures the highest standards of medical device safety and efficacy, thereby facilitating timely access to life-saving technologies worldwide.

Conclusion

A global comprehensive regulatory model for medical devices refers to a unified framework that governs the development, manufacturing, marketing, and usage of medical devices worldwide. Such a model would attempt to guarantee the safety, efficacy, and quality of medical devices, while making it easier for medical devices to quickly access markets to fulfil the healthcare needs. We conclude that medical devices should be a set of internationally agreed-upon standards and regulations that govern the design, manufacturing processes, and performance criteria for medical devices. These standards would ensure consistency and interoperability across different regulatory jurisdictions. A classification scheme that is based on risk that categorizes medical devices based on the potential risks to patients and users. This system determines the level of regulatory scrutiny and requirements for each class of devices. A standardized process for the pre-market assessment of medical devices, including clinical trials, performance testing, and quality assurance measures. Through this procedure, devices would be assessed for efficacy and safety prior to being released onto the market. Robust mechanisms for monitoring the safety and performance of medical devices once on the market. These mechanisms cover post-market research, adverse event reporting, and surveillance systems to detect and address any issues that may arise after devices are in use. Mandates implement quality management systems by producers to guarantee continuous adherence to legal requirements and consistent manufacturing. These mechanisms include procedures for quality control, risk management, and post-market monitoring. The mechanism should be flexible and accommodate advances in technology and innovation in medical device development, while maintaining stringent safety and quality standards. The mechanism should promote regulatory harmonization and expand worldwide access to secure and efficient medical equipment. Overall, a global comprehensive regulatory model for medical devices aims to strike maintaining patient safety, while striking a balance, facilitating innovation, and enabling timely access to life-saving medical technologies worldwide.

Disclosure

The authors declare that they have no competing financial interests or personal relationships that could appear to influence the work reported in this paper.

Conflict of interest

The authors have no conflicts of interests related to this publication.