June 20, 2025

The European Commission has decided to exclude Chinese companies from participating in EU public tenders for medical devices worth over €5 million. Although these high-value contracts account for only 4% of tenders by number, they represent approximately 60% by value—making this a significant restriction. The rule enforces a requirement that accepted supply bids contain no more than 50% Chinese-made content unless no alternatives exist.

April 28 – May 7, 2025

From April 28 through May 7, 2025, Malaysia’s Medical Device Authority solicited industry feedback on two draft guidance documents: one outlining exemption procedures for devices manufactured solely for export, and another for special-access import/supply of unregistered devices. Stakeholders were invited to comment on application requirements, supporting documentation, and post-exemption obligations, ahead of finalizing the guidelines in mid-2025

April 18, 2025

On April 18, 2025, China’s National Medical Products Administration released the “Implementation Rules for the Special Review of Innovative Medical Devices.” These rules, based on the earlier “Innovative Medical Devices Review Procedures,” establish a fast-track pathway for breakthrough device classes, clarifying eligibility criteria, application dossiers, and review timelines. Manufacturers of novel technologies can now engage with a defined, centralized review mechanism aimed at accelerating market entry for cutting-edge devices.

March 10, 2025 

The U.S. Federal Trade Commission (FTC) filed a lawsuit to prevent the $627 million acquisition of Surmodics by GTCR, two leading manufacturers of specialized coatings for medical devices like catheters. The FTC unanimously voted to block the merger, asserting that it would reduce competition. Despite this, Surmodics plans to proceed with the merger, which was approved by its shareholders last year.​ 

February 15, 2025 

The European Union has threatened to limit access for Chinese medical device manufacturers after an investigation revealed that Beijing discriminates against EU manufacturers in public contract bids. This move could result in a five-year restriction on Chinese companies accessing EU contracts if the issue isn't resolved. 

January 24, 2025 

The U.S. Food and Drug Administration (FDA) has removed draft guidance and web pages focused on promoting diversity in clinical trials. This action follows an executive order aimed at dismantling diversity, equity, and inclusion initiatives across federal agencies. The removed guidance aimed to increase participation of underrepresented groups in clinical trials to ensure data reflects a diverse population. 

January 29, 2025 

Robert F. Kennedy Jr., nominated to lead the U.S. Department of Health and Human Services, committed during a Senate confirmation hearing to finalizing regulations aimed at increasing the participation of diverse patient populations in clinical trials. This follows the removal of draft guidance concerning diversity from the FDA's website. 

February 28, 2025 

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended four new medicines for approval, including Deqsiga (human normal immunoglobulin) for immunodeficiencies and Lynozyfic (linvoseltamab) for relapsed and refractory multiple myeloma.​ 

January 12, 2025 

The EU's Health Technology Assessment Regulation (HTAR) came into effect, introducing joint clinical assessments at the European level for new treatments. Initially, oncology medicinal products and advanced therapy medicinal products (ATMPs) will be evaluated under HTAR, followed by orphan drugs from 2028, and all centrally authorized medicinal products from 2030. 

February 14, 2025 

The FDA approved insulin aspart-szjj, sold under the brand names Merilog and Merilog Solostar, as a biosimilar to Novolog. This marks the first rapid-acting insulin biosimilar approved by the FDA, offering more options for diabetes management. 

January 14, 2025 

The European Medicines Agency authorized Ahzantive and Baiama, both biosimilars to Eylea (aflibercept), for treating various eye conditions, including wet age-related macular degeneration and diabetic macular edema.​ 

December 15, 2024 

The European Medicines Agency authorized Imuldosa, a biosimilar to Stelara (ustekinumab), for treating plaque psoriasis, psoriatic arthritis, and Crohn's disease. Similarly, the FDA approved ustekinumab-kfce (Yesintek) as a biosimilar for the same conditions.