Regulators Communicate Measures Regarding Potential Supply Disruptions During Middle East Conflict

By Amber Baade and Megan Gottlieb

Health authorities have begun alerting relevant parties that they are monitoring or taking measures to address potential supply disruptions (or shortages) associated with the conflict in the Middle East. 

As a global in-country representative and consultancy, Emergo by UL has received several of these updates. A short list has been compiled below.

Health Canada: MDC Bulletin and specified medical devices list

At the end of March, Health Canada (HC) released an MDC Bulletin from the Health Product Shortages Directorate notifying that they are currently monitoring medical device supply risks resulting from disrupted shipments associated with the conflict in the Middle East. 

HC has begun targeted outreach to manufacturers and Medical Device Establishment License (MDEL) holders and also reminds stakeholders that manufacturers of Class I-IV devices and importers of Class I devices must report shortages and discontinuations for devices on the List of Specified Medical Devices. Manufacturers are also encouraged to report shortages and discontinuations of devices not on the list. 

Ministry of Food and Drug Safety: Rapid regulatory support guidelines  

The South Korea, Ministry of Food and Drug Safety (MFDS) released the Guidelines for Rapid Regulatory Support Related to the Middle East War (in Korean), which provides high-level details on expediting certain review procedures as of April 5, for manufacturers that expect disruptions in the supply of raw materials for their devices (e.g., IV sets, syringes, and needles). These procedures are expected to remain for 6 months, though may be terminated earlier or extended if necessary. 

Manufacturers may be eligible for expedited review of change requests for a change in raw materials, and K-GMP may be conducted via a desktop audit (document review) in lieu of on-site audits. In such cases, a rationale stating the intent to address potential supply instability must be documented, and it is recommended to consult with the MFDS before making this type of application.

Therapeutic Goods Administration: Email to Australian sponsors

The Australian Therapeutic Goods Administration (TGA) has sent an official communication to notify Sponsors that it is monitoring potential impacts on the supply of medical devices, including IVDs. As such, the TGA has begun targeted outreach for devices known to be manufactured in or supplied through the affected region. The TGA also requests information from all sponsors with devices in the Australian Register of Therapeutic Goods (ARTG) regarding current or anticipated supply disruptions.

Sponsors are encouraged to notify the TGA as soon as possible if any product availability issues arise so that they may support appropriate mitigation strategies.

Medical Device Authority: Notification of priority device lists 

The Malaysia Medical Device Authority (MDA) has sent a notification to all establishments that it is currently monitoring stock availability and supply continuity and to request relevant distribution records for certain priority products to be submitted monthly, beginning this month (due by April 17, and then the fifth day of each month thereafter). 

The priority device list includes a total of 40 general device types under the following four categories: (1) consumable medical devices, (2) implantable medical devices, (3) single-use surgical instruments, and (4) IVD reagents/test kits. The list focuses on devices that are critical for daily treatment, operating rooms/theatres, and are high-usage, as well as devices that are vulnerable to supply/logistics disruptions. It is intended as a priority list and is not absolute or exhaustive.

The MDA has provided a template for this reporting, to be submitted via a Google Form.

Concluding remarks

This is a burgeoning trend of regulators to notify manufacturers and importers that they are aware of the potential for supply disruptions as a result of the current geopolitical crisis in the Middle East. 

Emergo by UL anticipates that we will continue to receive more of these communications in the coming months.