Regulatory Update

Weekly Regulatory News

This week in global device regulatory news, the US FDA unveiled plans for unannounced inspections at foreign device manufacturing sites, and Brazil’s Anvisa opened a targeted consultation on a new device framework while setting phased dates to integrate health‑surveillance fee payments into its foreign‑trade portal.

Published on:
May 14, 2025

UNITED STATES

FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities

The FDA released a big shift for Non-U.S. Medical Device Manufacturers to get inspected without pre-notice. Historically, non-domestic manufacturers selling into the U.S. had a 8–10 weeks pre-warning and could prepare after the FDA made first contact and arrange with the FDA for inspection dates.

The FDA has now announced that it intends to begin conducting unannounced on-site inspections at foreign facilities. With this shift, the FDA is further ensuring that every product entering the U.S. is safe, legitimate, and honestly made. Unannounced inspections will also help expose bad actors—those who falsify records or conceal violations—before they can put American lives at risk. Or to say it in the words of the FDA Assistant Commissioner for Inspections and Investigations Michael Rogers “These inspections provide real-time evidence and insights that are essential for making fact-based regulatory decisions to protect public health.”

Learn more about FDA US Medical Device Registration.

BRAZIL

Anvisa Launches Targeted Consultation on New Medical Device Regulatory Framework

On May 13, Anvisa will launch a targeted consultation on proposed regulations for medical devices, with a focus on single-use and reusable products, as well as processing best practices. The virtual event will begin at 9:00 a.m. (Brasília time) and is exclusively for members of the National Health Surveillance System (SNVS). Contributions collected between May 13 and June 13, 2025, will support the drafting of four regulatory standards ahead of a broader public consultation.

Anvisa Updates Schedule for Integrated Payment of Health Surveillance Fee (TFVS)

Following the temporary suspension of the implementation timeline on April 4, Anvisa has released an updated schedule for integrating the payment of the Health Surveillance Fee (TFVS) into the Single Foreign Trade Portal. After validating system corrections between April 21 and May 2, the revised dates for integration into the Centralized Payment of Foreign Trade (PCCE) are as follows:

  • May 12, 2025: LI/LPCO import petitions for food
  • May 26, 2025: LI/LPCO import petitions for cosmetics, sanitizing products, standards, baby bottles, and biological material
  • June 2, 2025: LI/LPCO import petitions for drugs and controlled substances
  • June 9, 2025: LI/LPCO import petitions for medical devices

A manual to guide the sector will be published soon on Anvisa’s official portal for ports, airports, and borders.

Learn more about ANVISA Brazil Medical Device Registration.

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