Regulatory News
Stay updated with the latest regulatory news from around the world. Medical device regulations, pharmaceutical compliance updates, and industry announcements.
Showing 5 news articles
December 1, 2024
FDA Launches Idea Lab for Home Health Care Medical Devices
The FDA's Idea Lab, part of the Home as a Health Care Hub initiative, helps developers create medical devices for home use. Features include fictional personas for diabetes management, the Lilypad™ VR experience to explore patients' homes, and guidance on device integration, cybersecurity, and accessibility considerations.
Source: FDA
August 1, 2025
One Year of AI Act: MedTech Europe Calls for Coherent Implementation
One year after the AI Act's entry into force, MedTech Europe urges policymakers to ensure coherent implementation that complements existing MDR/IVDR legislation. They call for extending the application deadline for AI systems in medical devices to August 2029 and clarity on clinical investigation exemptions.
Source: MedTech Europe
November 15, 2024
TGA Recalls Cancer Council Sunscreen Clear Zinc Kids SPF50+ Due to Product Separation
The Therapeutic Goods Administration (TGA) has announced a market action for three batches of Cancer Council Sunscreen Clear Zinc Kids SPF50+ 110g due to potential product separation, which may affect the product's effectiveness. Consumers are advised to return the product for a replacement or refund.
Source: TGA Australia
November 14, 2025
EMA Recommends First-in-Class Treatment to Delay Onset of Type 1 Diabetes
EMA has recommended marketing authorisation for Teizeild (teplizumab), the first treatment to delay the onset of stage 3 type 1 diabetes in adults and children from 8 years with stage 2 diabetes. Clinical trials showed median time to stage 3 was 50 months with teplizumab vs 25 months with placebo.
Source: EMA
September 29, 2025
NMPA Announces New Policy for Importing Pre-Approval Commercial-Scale Batches of Overseas Drugs
NMPA issued Announcement No. 96, 2025, allowing pre-approval commercial-scale batches of overseas-marketed drugs to be imported into China. This applies to originator drugs, shortage list drugs, rare disease treatments, and drugs under accelerated registration. The policy aims to support early patient access to innovative and clinically urgently needed drugs.
Source: NMPA China