Medical Regulatory Authorities Research Articles

Medico-legal risks of point-of-care ultrasound: a closed-case analysis of Canadian Medical Protective Association medico-legal cases

BackgroundPoint-of-care ultrasound (POCUS) has become a core diagnostic tool for many physicians due to its portability, excellent safety profile, and diagnostic utility. Despite its growing use, the potential risks of POCUS use should be considered by providers. We analyzed the Canadian Medical Protective Association (CMPA) repository to identify medico-legal cases arising from the use of POCUS.MethodsWe retrospectively searched the CMPA closed-case repository for cases involving diagnostic POCUS between January 1st, 2012 and December 31st, 2021. Cases included civil-legal actions, medical regulatory authority (College) cases, and hospital complaints. Patient and physician demographics, outcomes, reason for complaint, and expert-identified contributing factors were analyzed.ResultsFrom 2012 to 2021, there were 58,626 closed medico-legal cases in the CMPA repository with POCUS determined to be a contributing factor for medico-legal action in 15 cases; in all cases the medico-legal outcome was decided against the physicians. The most common reasons for patient complaints were diagnostic error, deficient assessment, and failure to perform a test or intervention. Expert analysis of these cases determined the most common contributing factors for medico-legal action was failure to perform POCUS when indicated (7 cases, 47%); however, medico-legal action also resulted from diagnostic error, incorrect sonographic approach, deficient assessment, inadequate skill, inadequate documentation, or inadequate reporting.ConclusionsAlthough the most common reason associated with the medico-legal action in these cases is failure to perform POCUS when indicated, inappropriate use of POCUS may lead to medico-legal action. Due to limitations in granularity of data, the exact number of civil-legal, College cases, and hospital complaints for each contributing factor is unavailable. To enhance patient care and mitigate risk for providers, POCUS should be carefully integrated with other clinical information, performed by providers with adequate skill, and carefully documented.

Critical Control Points and Case Studies in the Production of Metal Additive Manufacturing Medical Device

The critical control points in the production quality management of metal additive manufacturing medical devices, including personnel, hardware, design and development, procurement control, production management and quality control are summarized from the perspective of supervision. The typical cases are analyzed to provide reference for medical device regulatory authorities and enterprises.

Stability of Medicines Transported by Cargo Drones: Investigating the Effects of Vibration from Multi-Stage Flight

The timely distribution of medicines to patients is an essential part of the patient care plan, and maximising efficiency in the logistics systems behind these movements is vital to minimise cost. Before drones can be used for moving medical cargo, medical regulatory authorities require assurance that the transported products will not be adversely affected by in-flight conditions unique to each drone. This study set out to (i) quantify the vibration profile by phases of flight, (ii) determine to what extent there were significant differences in the observed vibration between the phases, and (iii) assess the quality of flown monoclonal antibody (mAb) infusions used in the treatment of cancer. Vibrations emanating from the drone and transmitted through standard medical packaging were monitored with the storage specifications for mean kinematic temperature (2–8 °C) being met. Vibration levels were recorded between 1.5 and 3 g, with the dominant octave band being 250 Hz. After 60 flights, the quality attributes of flown infusions regarding size integrity were found to be no different from those of the control infusions. For example, the particle size had a variation of less than 1 nm; one peak for Trastuzumab was 14.6 ± 0.07 nm, and Rituximab was 13.3 ± 0.90 nm. The aggregation (%) and fragmentation (%) remained at 0.18 ± 0.01% and 0.11 ± 0.02% for Trastuzumab, 0.11 ± 0.01% and 2.82 ± 0.15% for Rituximab. The results indicated that in the case of mAbs, the quality assurance specifications were met and that drone vibration did not adversely affect the quality of drone-flown medicines.

Health questions on medical licensure applications: effective or counterproductive? A systematic review

Many medical regulatory authorities (MRAs) require their members and applicants to report information about their health on their medical licensure application and renewal forms. We wanted to determine whether this practice is effective in identifying physicians who have a health concern impacting their professional capacity and whether it influences members to seek treatment for their health concerns. Methods: A literature search was conducted in accordance with PRISMA publications standards. Results: From 7998 references found in all databases, after removal of duplicates and screening, five studies were included in this systematic review. None addressed the question of how effective health questions on licensure application forms are in identifying relevant health concerns. Stigma and fear of perceived ramifications of reporting mental health illness to MRAs were common reasons for physicians and medical students not seeking professional mental health care. Significance: MRAs who include health questions on their medical licensure applications should consider their effectiveness in identifying members who have health concerns that may impact their fitness to practise. Contrarily, these questions may deter members from seeking professional treatment for their own mental health. This is an important consideration, especially as burnout is prevalent among practising physicians and medical trainees.

Conversations on Cannabis and Mental Health: Recommendations for Health and Social Care Providers from Indigenous 2SLGTBQQIA+ People in Canada

With the recent legalization of cannabis in Canada, there is an urgent need for information about its effects on Indigenous populations due to the impact of cannabis on the mental health of Indigenous Peoples in Canada being largely unknown. Using the guiding principles of Etuaptmumk (Two-Eyed Seeing), Sharing Circles were held to hear the needs and experiences of Indigenous People in relation to their mental health and cannabis use. From these engagements and using gender-based and distinctions-based analysis, four recommendations were developed for academic institutions, medical regulatory authorities and health and social care providers (HSCPs) to consider when caring for Indigenous People living with mental health issues. The findings point to the disconnection between recent research on medical cannabis and its availability to Indigenous People through accessible mediums, HSCPs, and the lack of cultural safety in health and social services. The four recommendations provided are helpful to both educate frontline HSCPs about the needs and experiences of Indigenous People and improve access to current information and best practices for Indigenous People who use cannabis for mental health from the regulatory and representation perspective.

Medico-Legal Cases in Breast Imaging in Canada: A Trend Analysis.

Purpose: Breast imaging accounts for a large proportion of medico-legal cases involving radiologists in several countries and may be a disincentive to breast imaging. As this has not been well studied in Canada, we evaluated the key medico-legal issues of breast imaging in Canada and their implications for health care providers and patient safety. Methods: In collaboration with Canadian Medical Protective Association (CMPA), we obtained information from the medico-legal repository, including civil-legal, medical regulatory authority (College) and hospital complaints occurring between 2002-2021. Canadian Classification of Health Interventions (CCI) codes were used for breast imaging and biopsy. Trend analysis was done comparing cases involving breast imaging/biopsy to all cases where a radiologist was named. Results: Radiologists were named in 3108 medico-legal cases, 188 (6%, 188/3108) of which were CCI coded for breast imaging or biopsy. Factors related to radiologists were most frequent (64%, 120/188), followed by team (23.4%, 44/188) and system (6.9%, 13/188). Equal representation of male and female radiologists was found (IRR = 1.22; 95% CI: .89, 1.56). In a 10-year test window from 2006 - 2015 we identified an increasing trend for all cases involving radiologists (P = 0,0128) but a decreasing trend for cases coded with breast imaging or biopsy (P = 0,0099). Conclusions: A significant decrease in cases involving breast imaging were found from 2006-2015, accounting for 6% of the medico-legal cases. The lower risk of breast imaging medico-legal issues may encourage more radiologists in breast imaging.

Explored the Function of Electromagnetic Compatibility (EMC) of Medical Devices from the Perspective of Test

To improve the electromagnetic compatibility (EMC) quality of medical devices, improve the efficiency of EMC testing, and promote the speed of market approval. The unqualified cases of EMC test items of medical devices in recent years were statistically analyzed, and the reasons of low EMC quality of medical devices were analyzed from the perspective of test. Based on the analysis of the reasons, the suggestions were given from the perspectives of medical device manufacturers and testing organizations. In order to ensure the quality of EMC of medical devices, medical device manufacturers, regulatory authorities and inspection and testing institutions should strengthen the monitoring and evaluation of medical device electromagnetic compatibility, to ensure the safety of products work together to promote the development of the medical device industry healthily and orderly.

Study on Influencing Factors of Artificial Hip Joint Test Quality Based on ISO/IEC 17025 and GLP

Taking artificial hip joint test as the object, integrating ISO/IEC 17025 and GLP, and establishing a new set of management requirements for test influence factors. The requirements of ISO/IEC 17025 and GLP regulations for influencing factors were compared and analyzed, the similarities and differences were found, and the two were integrated to formulate new management requirements for each influencing factor. From the personnel, equipment, materials, methods, reports, filing and other factors, a set of management requirements in line with ISO/IEC 17025 and GLP was formulated, so that the laboratory can provide the objective, real and accurate test data for medical equipment manufacturers and regulatory authorities. It can improve the test quality of the laboratory and ensure the authenticity and reliability of the test data and conclusions.

An Overview of Private Medical Education in Pakistan

The study's primary purpose was to investigate the challenges and prospects of Private Medical Education (PME) in Pakistan. Private Medical Education in Pakistan has grown significantly in recent decades, and the Punjab province has been at the vanguard of this trend. The desk research was used to gather information and data from books, journals, reports, databases, and online resources, including relevant websites related to private medical education in Pakistan. The author selected several papers, a few from PubMed and many from Google Scholars, to gain insights into the challenges and prospects of the sector to develop thought for the paper. Private Medical Education in Pakistan is an integral part of the Asian Medical Education (ME) landscape, proliferating in response to the increasing demand for medical education. As a result, PME in Pakistan has bright prospects to contribute significantly to the continent's development in terms of ME and economy. The Pakistan Medical Commission (PMC) is Pakistan's medical education and training regulatory authority. It is responsible for ensuring that medical colleges and universities in the country meet the required standards for the quality education and training of medical professionals. However, ME in Pakistan faces several challenges: high tuition fees, limited funding, shortage of MBBS doctors, lack of government support and insufficient medical infrastructure in rural areas, and concerns about quality and standards. Of course, these challenges are not unique to Pakistan but also to many developing countries in Asia, but they are significant. They require the immediate attention of the Pakistan Government to address the issues. Keywords: Growth, Challenges, Prospects, Private Medical Education, Pakistan

Assessment of the effectiveness and efficiency of the economic community of West African States Medicines Regulatory Harmonization initiative by the pharmaceutical industry.

Background: Following the establishment of Economic Community of West African States Medicines Regulatory Harmonization (ECOWAS-MRH) initiative in 2017, it was considered timely to carry out an evaluation of the current status of the initiative's operating model by the pharmaceutical industry users. This study examined the challenges being encountered and identified strategies that would strengthen the ECOWAS-MRH initiative moving forward. Methods: The Process Effectiveness and Efficiency Rating (PEER) questionnaire was used to collect data from manufacturers who have submitted applications to the joint assessment procedure and had identified recommendations for improving the performance of the ECOWAS-MRH initiative. Results: Ten pharmaceutical manufacturer participants (innovator, generic foreign, generic local) all reported that harmonisation of registration requirements was a major benefit, allowing submission of the same dossier to multiple countries, reducing the application burden and saving time and resources. Additionally, receipt of the same list of questions from several countries enables the compilation of a single response package, resulting in shorter timelines for approvals compared to the individualised country responses. Another benefit of a harmonised registration process was the simultaneous accessibility of medicines in various markets. Key challenges included a lack of centralised submission and tracking, differences in regulatory performance of the national medical regulatory authorities, a lack of detailed information for applicants and a low motivation to use the ECOWAS-MRH route with a preference for other regulatory pathways in the ECOWAS member states. Conclusion: This study identified several approaches to increase the effectiveness of this initiative: the implementation of risk-based approaches such as use of reliance pathways; establishment of a robust information technology systems, building assessor capacity to facilitate processing and monitoring applications; and priority review of ECOWAS-MRH products.

Regulatory requirements and optimization of multiple criteria decision analysis to quantify the benefit-risk assessment of medical devices

ABSTRACT Introduction Worldwide medical device regulatory authorities increasingly rely on the benefit-risk ratio for decision-making. However, current benefit-risk assessment (BRA) methods are mostly descriptive, not quantitative. Areas Covered We aimed to summarize the regulatory requirements of BRA, discuss the feasibility of adopting multiple criteria decision analysis (MCDA), and explore factors for optimizing the MCDA for quantitative BRA of devices. Expert Opinion Regulatory organizations emphasize BRA in their guidance, and some recommend user-friendly worksheets to conduct qualitative/descriptive BRA. The MCDA is considered one of the most useful and relevant quantitative BRA methods by pharmaceutical regulatory agencies and the industry; the International Society for Pharmacoeconomics and Outcomes Research summarized the principles and good practice guidance of MCDA. We recommend optimizing the MCDA by considering the following unique characteristics of the device BRA: using data from state of the art as a control and clinical data from post-market surveillance and literature; considering the device’s diverse characteristics when selecting controls; assigning weight according to type, magnitude/severity, and duration of benefits and risks; and including physician and patient opinions in the MCDA. This article is the first to explore using MCDA for device BRA and might lead to a novel quantitative BRA method for devices.

Models in Professional Regulation: Choices for Atlantic Canada?

ABSTRACTThis paper will identify existing models of professional regulatory reform that could ensure a single licensing process that results in multi-jurisdictional licensure. The paper will also distinguish models or ad hoc arrangements that fail to achieve such a result. This is a timely topic in Canada because its professional regulatory framework is being examined for modernization.The Canadian professional regulatory framework for health care providers is a legacy of the Constitution of 1867. It can be characterized as a Federation of 13 different jurisdictional systems with each province or territory having exclusive jurisdiction over regulation of its health professionals. This results in differing entry to practice requirements, standards of practice, classes or categories of registration and transfer criteria for eligibility from other provinces.The United States nursing state board regulators, the Australian Commonwealth, and their state governments have moved from their original regulatory frameworks to modern ones. Their models are more supportive of mobility, cross-border virtual care, education, and health provider professional development and well-being. Aside from recent discussions in the 4 Canadian Atlantic provinces, there has been little will, effort, or advancement to modernize the regulatory framework in Canada to support multi-jurisdictional licensure. This paper aims to briefly describe 6 existing models that support multijurisdictional licensure. In the fall of 2022, the 4 Atlantic Premiers (akin to state Governors in the US) asked each of their medical regulatory authority (akin to State Medical Boards) to develop a licensing system such that physicians could practice in all 4 Atlantic provinces without the need to acquire multiple licenses. Two models will be discussed that meet this recently stated objective of the Atlantic Premiers while the others do not.

Abstract P2-15-10: Impact of the withdrawal of textured breast implants from the market on breast reconstruction practices

Abstract Background: In November 2018, the SOFCPRE (Société Française de chirurgie plastique, reconstructrice et esthétique) recommanded that textured Biocell© implants should no longer be used because of a potential risk of anaplastic large cell lymphoma (ALCL). This decision was confirmed in April 2019 by the French Medicines Agency (ANSM, Agence nationale de sécurité du médicament), and the French Medical Regulatory Authority. In the Georges-François Leclerc Cancer Center (Dijon, France), we suspended the use of textured Biocell© implants from November 2018 onwards, in favour of smooth surface, round implants. Objective: To assess the impact of textured implant withdrawal on surgical practices in breast reconstruction (BR) in a single French cancer center. Methods: This is a retrospective, single-centre study in the Georges-François Leclerc Cancer Center (Dijon, France). Surgical practices of BR and complications were compared between 2 periods: before the withdrawal of textured implants from the market (Period 1: September 2017-November 2017) and after (Period 2: December 2018-March 2020). Patients were included if they were operated on for the first time for immediate or secondary BR in either period. Univariate analysis was performed to compare before vs after groups, and to analyse surgical practices (rates of autologous techniques and breast implant) of BR and complications ((defined as any complication grade IIIB or higher according to the Clavien Dindo classification) between the 2 periods. Results: Data from 168 and 159 BR were collected from Periods 1 and 2 respectively. Characteristics were comparable between groups.The rate of BR with implants was significantly lower in period 2 compared with period 1 (23.9% vs 53.6%; p< 0.001). Similarly, autologous BR increased significantly in period 2 for muscle sparing latissimus dorsi (2.4% vs 12.6%; p< 0.001) and exclusive fat grafting (9.5% vs 21.5%; p< 0.01). Others autologous techniques was comparable between the two periods (DIEP and latissimus dorsi). The number of complications decreased in period 2 (10% vs 18.4% in period 1, p=0.04). Conclusion: After the withdrawal of textured implants, we observed a significant change in surgical practices for BR in our center. The rate of reconstruction with implants decreased in favour of autologous techniques. This change in practice was accompanied by a decrease in complications. Surgical techniques for breast reconstruction between the two periods Period 1: September 2017-November 2017;Period 2: December 2018-March 2020. DIEP, Deep Inferior Epigastric Perforator; SD, Standard deviation Citation Format: CLEMENTINE JANKOWSKI, Maxime Martinez, Vincent Laura, Pierre Burnier, CHARLES COUTANT. Impact of the withdrawal of textured breast implants from the market on breast reconstruction practices [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P2-15-10.

Surgeons disciplined by regulatory bodies in Canada between 2000 and 2017.

SummaryIdentifying characteristics of disciplined surgeons is important for public safety. A database of all physicians disciplined by a Canadian provincial medical regulatory authority (College of Physicians and Surgeons) between 2000 and 2017 was constructed, and comparisons between surgeons and other physicians were undertaken. Of 1100 disciplined physicians, 174 (15.8 %) were surgeons. Obstetrics and gynecology was the specialty with the most disciplined surgeons (57 of 174 [32.8%]), followed by general surgery (48 of 174 [27.6%]). The overall disciplinary rate for surgeons was higher than for other physicians (12.59, 95 % confidence interval [CI] 10.69–14.83 v. 9.85, 95 % CI 8.88–10.94 cases per 10 000 physician-years, p = 0.013). Even after adjusting for surgeon age, sex, international medical graduation and years in practice, surgeons remained more likely than other physicians to be disciplined for standard of care issues (55.6%, 95% CI 46.6–64.2 v. 38.7%, 95% CI 32.6–45.2, p < 0.001).

Use of collagenase to isolate adipose tissue-derived stem cells – substantial manipulation or not?

Background: Collagenase is commonly used to isolate the stromal vascular fraction (SVF) or adipose tissue-derived stem cells (ADSCs) from human adipose tissue. Enzymatic breakdowns may be a substantial manipulation according to the classifications of medical regulatory authorities. This study investigates the possible effects of human adipose tissue dissociation with collagenase on in vitro function and behavior of ADSCs. Methods and results: Adipose tissue from nine donors was divided into two equal fractions. SVF was then isolated either mechanically or with collagenase, respectively. The resulting cells were analyzed for their surface markers directly after isolation and at passage five. Proliferation, tri-lineage differentiation, and secretome markers were measured after passage four. Using collagenase compared to mechanical isolation did not alter the expression of typical surface markers of ADSCs. ADSCs isolated with collagenase showed a significantly shorter population doubling time (p &lt; 0.001), a significantly higher mean specific GPDH-activity, a stronger intensity in perilipin staining (p = 0.005), and a significantly higher extracellular calcium deposition (p = 0.006) than mechanically isolated ADSCs. The expression of adipogenic and osteogenic marker genes was not different in mechanically versus enzymatically isolated ADSCs. There were no significant differences in proteoglcyan production (p &gt; 0.05) and the concentration of type 2 collagen. Except for an increased CCL2 concentration in mechanically isolated ASDCs (p = 0.01), there were no significant differences in the concentration of secreted proteins between both isolation methods. Conclusions: The use of collagenase does not substantially impair central in vitro characteristics and functions of human adipose tissue-derived stem cells.

Research on the structure of smart medical industry based on the background of the internet of things

Abstract In view of the current development trend of the smart medical industry in the context of the internet of things, this study conducts an evolutionary game analysis on information technology providers, medical institutions, digital medical equipment providers, and medical regulatory agencies in the smart medical industry. This study also analyzes the stable state of the future development of the smart medical industry and performs simulation calculations through MATLAB software. The research results show that the overall development trend of the smart medical industry structure in the future is consistent with the development trend of each industry structure. Under the strategic background of the supervision of medical regulatory agencies, information technology providers and digital medical equipment providers, respectively, provide the smart medical industry with the latest information technology and digital medical equipment to ensure the technical support of the smart medical industry. The smart medical industry provides corresponding medical talents and medical equipment to ensure the demand for talents and equipment of the smart medical industry, so that the structure of the smart medical industry can continuously improve the level of smart medical technology in the future development and ultimately promote the overall development of the smart medical industry.

Evaluation of the Effectiveness and Efficiency of the East African Community Joint Assessment Procedure by Member Countries: The Way Forward.

Background: For almost a decade, the East African Community has implemented the Medicines Regulatory Harmonization (EAC-MRH) programme among its member states to harmonise technical requirements and standards for medical products regulation, jointly conduct scientific review of medical product dossiers to assess safety, efficacy and quality, inspect pharmaceutical manufacturing sites and streamline decision-making processes. This initiative enables the cost-effective use of limited resources and efficient and effective delivery of regulatory services to be determined, thus instilling transparency and accountability in all stakeholders, optimising the pharmaceutical market and economic development and improving access to safe, high-quality, effective medicines in the region. The aim of this study was to evaluate the effectiveness and efficiency of the current operating model of the EAC-MRH initiative, including challenges faced and to identify opportunities for improvement. Methods: The Process Effectiveness and Efficiency Rating (PEER) questionnaire, which was used to identify the benefits, challenges, and suggestions for improving performance of EAC-MRH initiative, was completed by assessors representing seven EAC authorities in the joint assessment procedure. Semi-structured interviews were also carried out to validate the responses. Results: This initiative has been of considerable value as it moves toward achieving its main objectives of shorter timelines for approval of medicines, information sharing among regulators and capacity building for assessments, resulting in quicker access and increased availability of medicines for patients in the region. However, the key challenges identified that have hindered effectiveness and efficiency were the lack of a centralised submission and tracking system; inadequate human resources, manufacturers’ failure to submit the exact same dossier to all countries of interest; lack of an integrated information management system; lack of information on national medical regulatory authority or EAC websites; and challenges in monitoring and tracking assessment reports. Conclusion: The use of a robust information technology system for the central tracking of EAC products is essential to address the identified challenges and improve regulatory effectiveness and efficiency. One central point for payment is needed to expedite the process and to ensure transparency and the availability of information on decision making on national and regional websites. Other key strategies for enhancement include improving the capacity of assessors, work and information sharing and a coordination mechanism for the regional joint assessment, with the eventual establishment of a regional medicine agency.

Implementation of National Licensing Examination (NLE) and its Impact on Global Healthcare: A Systematic Review

Background: A license required for full practice - National licensing examinations (NLEs) are required in most of the countries with well-established medical regulatory authorities. Objective: This systematic review aims to investigate the impact of NLEs after their implementation worldwide. Methods: Systematic review designed as per Kane's validity framework developed by Olivary et al. by exploring online databases such as: Wiley Online, Embase Medline (EBSCO); PubMed; JSTOR; Google Scholar and Science Direct; from&#x0D; January 2005 to December 2020. Results: NLE exams and better patient outcomes (communication, satisfaction) are positively related and such exams help in development of a common medical curriculum and a better post-graduation entry point. Conclusions: In the present era, where more medical graduates are flying all across the globe for employment than ever before, NLE is becoming inevitable and helps to ensure that medical training satisfies a minimum standard of quality, which varies among Medical schools and colleges within a country and globally. Continual improvement is crucial for the identification of gaps in the medical licensing exams. The license holders must comply with National authorities and stay active in academic and clinical activities to stay licensed.

Evaluating interventions to improve ethical decision making in clinical practice: a review of the literature and reflections on the challenges posed

Since the 1980s, there has been an increasing acknowledgement of the importance of recognising the ethical dimension of clinical decision-making. Medical professional regulatory authorities in some countries now include ethical...

Orthodontics on sale: fixed appliances on E-commerce platforms

Abstract Introduction The sale of orthodontic materials, considered as medical devices, is regulated in order to protect patients. The availability of orthodontic products on e-commerce platforms, however, may go unregulated and compromise patient safety. Objective The present study aimed to investigate the sale of fixed orthodontic appliances on a local and global e-commerce platform. Materials and Methods A cross-sectional analysis of orthodontic materials sold on Shopee and Amazon was conducted using a specific keyword search for brackets, arch wires and ligatures. After deleting duplicates and irrelevant search results, the top 50 products for each keyword search were analysed. Product name, the type of product, seller, cost, star rating, the number of reviews, the number of sales, shipping location and brand identification were recorded. Brand registration with a medical device regulatory authority was checked. Collected data were tabulated in Google (spread)sheet to derive descriptive statistics and frequency tables. Results A total of 800 search results were screened. Three hundred and forty-eight relevant results were identified, approximately two-thirds of which originated from Shopee. Ligatures generated the highest search outcome in both Shopee (39%) and Amazon (80%). Fixed orthodontic materials sold on Shopee resulted in a larger number of reviews, higher star ratings and a lower cost per item compared to those supplied by Amazon. Products on Amazon were more likely to have brand identification (97%) compared to Shopee (5%). None of the identifiable brands on Shopee were registered with regulatory bodies, whereas eight products listed on Amazon were registered. A large portion of shipping locations originated from China for both e-commerce platforms. Conclusions Orthodontic brackets, arch wires and ligatures are more readily available on Shopee compared to Amazon. The quality and safety of these products cannot be assured as the majority of the products were either not clearly labelled or their registration was not identified under the regulation of medical devices.