Trends in Medical Device Shortage Reporting

Overview

Medical device shortages have become a critical issue worldwide, resulting from multiple interacting factors. The COVID-19 pandemic exposed the vulnerability of medical device supply chains, and regulatory authorities in various countries are actively strengthening transparency and promoting stable supply. From 2024 to 2025, regulatory responses have accelerated significantly.

Regulatory Developments in Major Regions

United States of America

The FDA (Food and Drug Administration) published final guidance on January 6, 2025, regarding medical device shortage reporting and strengthened the regulatory framework under Section 506J of the FD&C Act. This guidance requires manufacturers to notify the FDA of permanent discontinuances or interruptions in manufacturing that could cause significant disruptions to domestic supply of certain devices during or in anticipation of a public health emergency.

The FDA maintains the “506J Device List,” which identifies devices subject to mandatory notification requirements. Manufacturers are required to report supply chain disruption indicators, distribution pressures, and user-reported availability concerns. Identified shortage causes include manufacturing problems, quality issues, natural disasters, geopolitical factors, logistics delays, and public health concerns. Additionally, patients, healthcare providers, healthcare facilities, distributors, and group purchasing organizations are encouraged to notify the FDA of supply chain disruptions via email to deviceshortages@fda.hhs.gov.

European Union

In Europe, challenges associated with the implementation of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) had become increasingly serious regarding transition periods. To address these issues, Regulation (EU) 2024/1860, which came into effect on July 9, 2024, strengthened medical device shortage risk mitigation measures.

Article 10a of the amended regulation requires manufacturers of MDR and IVDR-regulated devices to report supply interruptions or discontinuations that could cause significant disruptions to domestic supply within two days of confirming a threat to public health to the competent authorities. Furthermore, a new question and answer document on pre-notification requirements for supply interruptions or discontinuations of certain devices has been issued effective January 10, 2025.

Survey data from the European Medicines Agency (EMA) indicates that 55% of EU patients have experienced pharmaceutical shortages and 45% have experienced medical device shortages, reflecting an ongoing serious situation. Delivery issues account for approximately 8% of shortages, and measures to strengthen supply chain resilience are being implemented. On December 16, 2024, the European Commission announced proposed amendments to the MDR and IVDR aimed at resolving certification bottlenecks and improving access to medical devices.

Canada

Health Canada has implemented comprehensive measures to address health product shortages based on the plan titled “Building Resilience: Health Canada’s Plan to Address Health Product Shortages, 2024 to 2028,” announced in June 2024. Regulatory amendments that came into effect on November 27, 2021, require manufacturers to submit initial reports of recognized medical device shortages or discontinuations within five business days via an electronic reporting form, and to submit additional reports within two business days when information changes or is updated.

Since the pandemic, concerns regarding medical device supply chain vulnerabilities have increased, and the information sharing framework between regulatory authorities and industry has been strengthened. One reason for Canada’s vulnerability to medical device shortages is that the Canadian market represents only approximately 2% of the global medical device market, with most devices being imported and often sourced from single suppliers.

Japan

In Japan, a medical device adverse event reporting system has been established through the Pharmaceuticals and Medical Devices Agency (PMDA). Reporting of medical device adverse events is mandatory from manufacturers and healthcare professionals, even when causality is unclear. For supply shortages, reporting is required for four statuses: early warning signs, actual shortage occurrence, status changes, and recovery.

Currently, no specific new regulations regarding medical device shortage reporting are confirmed, but active measures have been taken to address pharmaceutical shortages, and the Ministry of Health, Labour and Welfare began publishing pharmaceutical supply status information on its website from April 2024. In the future, enhanced surveillance systems and expanded reporting requirements for medical devices may be considered, making the transparency of supply status and establishment of reporting procedures increasingly important for medical device manufacturers.

France

France’s strategic stockpiling system of medical supplies plays an important role in ensuring health security. The French Public Health Agency is responsible for purchasing, manufacturing, importing, storing, and distributing medical supplies to protect the public from serious public health threats. Through this strategic stockpiling framework, the nation can respond rapidly to supply shortages. Additionally, the “France 2030” national investment plan aims to make France an autonomous and innovative European leader in the pharmaceutical sector by 2030. The plan allocates 7.5 billion euros for pharmaceutical development and domestic production enhancement, with special focus on four areas: infectious disease response medications, biopharmaceuticals, digital healthcare, and innovative medical devices.

Australia

In Australia, no specific reporting system for medical device supply shortages has been identified, but the Therapeutic Goods Administration (TGA) manages medical device regulatory approval processes. The TGA provides guidelines to ensure the quality, safety, and efficacy of medical devices, and manufacturers and importers must comply with these regulations. A post-market surveillance reporting process for medical devices is also in place, requiring reporting of adverse events and recall information.

Principal Causes of Medical Device Shortages

The major causes of medical device shortages are as follows:

Surge in Demand from the COVID-19 Pandemic Worldwide demand for devices such as ventilators and pulse oximeters surged dramatically, overwhelming supply. Although post-pandemic investments in expanded manufacturing capacity have been made, full normalization of supply-demand balance requires time.

Supply Chain Disruption Semiconductor shortages and raw material procurement difficulties have disrupted medical device production. International logistics disruptions have caused delays in component and finished product transportation, with geopolitical risks contributing to supply chain network reconfiguration effects.

Insufficient Domestic Production Capacity Many countries maintain low domestic medical device production ratios and are heavily import-dependent. For example, Japan’s domestic ventilator production ratio remains at approximately 42%, reflecting high dependence on global supply chains.

Government Subsidy Policies Increasing Demand Government subsidies to healthcare facilities promoting medical device purchases increased demand, contributing to supply shortages.

Labor Force Shortages Labor shortages in logistics industries have caused delays in medical device transportation and distribution. Rising wage levels in developed countries have made it difficult to secure workers for labor-intensive distribution and logistics operations.

Limited Supply Sources for Specific Raw Materials and Components Limited supply sources for certain critical raw materials and components have created procurement difficulties. Dependence on materials with limited suppliers—such as silicon wafers, rare earth elements, and specific chemicals—has become a bottleneck in medical device manufacturing.

Inventory Management Challenges Inventory management systems in healthcare facilities and distributors have been insufficient to respond to surges in demand. Following pandemic-related supply shocks, excessive purchasing behavior at the healthcare level (the so-called bullwhip effect) has created ongoing inventory pressures throughout distribution channels.

Global Trends and Business Implications

Global medical device trade has increased sevenfold over the past 30 years, reaching $700 billion in 2022, with approximately one-third comprising international transactions. Regulatory authorities are implementing new measures to prevent shortages and are working to improve transparency and access to medical devices. Particularly since the COVID-19 pandemic, awareness of supply chain vulnerabilities has increased, and the development of stronger monitoring and reporting systems is underway.

Companies with global operations must monitor regulatory developments in each country and establish appropriate reporting procedures. Understanding the shortage reporting requirements of major regulatory authorities—the FDA, EMA, Health Canada, Japan’s PMDA, and Australia’s TGA—is essential for regulatory compliance and maintaining market access. Timely and accurate information provision systems must be established. Furthermore, implementation of preventive measures such as supply chain resilience enhancement, domestic production capacity strengthening, and strategic inventory positioning will become increasingly important.

Regulatory authorities worldwide continue to strengthen measures addressing medical device supply shortages in pursuit of stable supply. Manufacturers are expected to not only comply with regulatory requirements but also contribute proactively to supply stability through improved demand forecasting accuracy and optimized supply chain management.

Table 1: Regulatory Response to Medical Device Shortages by Region

Region	Regulatory Authority	Key Requirement	Reporting Timeframe
United States	FDA	Section 506J notification of permanent discontinuance or interruption	Before public health emergency or during emergency
European Union	EMA/National Authorities	Notification of supply interruption/discontinuation threatening public health	2 days
Canada	Health Canada	Report of device shortage or discontinuation	5 business days (initial); 2 business days (updates)
Japan	PMDA	Four-status reporting (warning, shortage, change, recovery)	As identified
Australia	TGA	Post-market surveillance and adverse event reporting	As required

This table summarizes the primary regulatory frameworks and timelines for medical device shortage reporting across major jurisdictions, highlighting the increasing global emphasis on supply chain transparency and rapid communication of potential availability issues.