UNITED STATES

FDA Finalizes Guidance on Modular Review for Premarket Approval Applications and Humanitarian Device Exemptions

The FDA has issued its final guidance on the modular review process for Premarket Approval Applications (PMA) and Humanitarian Device Exemptions (HDE), effective January 2025. This guidance provides detailed procedures for the submission and review of modular PMAs and HDEs, streamlining the process for industry stakeholders. Issued by the Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research, the document is associated with Docket Number FDA-2024-D-5332. Public comments are welcomed and can be submitted online or in writing at any time.

Learn more about FDA US Medical Device Registration.

THAILAND

Auto-Approval System for Low-Risk Medical Devices

Starting January 15, 2025, the Thai FDA will implement an automated approval system for Class 1 low-risk medical devices. This system, known as the "Positive List," is designed to significantly reduce the time required to approve low-risk devices, facilitating faster market access for entrepreneurs.

The initiative ensures that users gain quicker access to vital medical devices while simplifying the approval process for businesses. Entrepreneurs and stakeholders can access further details through the links below:

• Press Release

• Positive List Reference

Priority Track for Chronic Disease Prevention Devices

On January 22, 2025, the Thai FDA announced a priority track for the registration and import of medical devices aimed at preventing and managing chronic diseases such as diabetes, hypertension, high cholesterol, cardiovascular diseases, and cancer.

Medical devices eligible for this fast-track process include:

• Glucose meters

• Blood pressure monitors

• Blood lipid test devices

• Echocardiograms

• Cancer screening tools

• Electrocardiograms (ECGs or EKGs)

This initiative underscores the FDA’s commitment to combating the growing prevalence of chronic diseases in Thailand. For more information on the priority track, visit the official announcement.

Learn more about TFDA Thailand Medical Device Registration.

‍