Regulatory Update

Weekly Regulatory News

The Clinical Trials Coordination Group (CTCG) published a Q&A for clinical trial sponsors on safety reporting. Highlights include active RFI monitoring, immutable annual reports, and CTIS transition guidelines.

Published on:
July 16, 2024

EUROPE

EU Regulation: Safety Reporting Guidelines for Studies Specified

Active Monitoring Required: Sponsors must actively monitor the RFI (Request for Further Information) folder, as the CTIS (Clinical Trials Information System) portal does not send separate notifications.

Annual Report Submission: Once annual reports are sent, they cannot be changed or canceled. In case of a critical error, sponsors should contact the supervising member country's contact person, whose list is available on the European Commission's website.

Transition Phase Handling: During the transition phase of studies, if a study is already in CTIS, the annual report should be sent to CTIS. Sponsors should wait for transition approval before sending the report, but no later than 120 days from the data lock point (DLP) date, with a possible 60-day extension.

EU Regulation 2024/1860: Eudamed Rollout and Supply Interruption Notices

Eudamed Roll-Out: Accelerates the mandatory use of the Eudamed database for available and functional modules by the end of 2025, enhancing transparency and providing up-to-date information about devices on the EU market.

Supply Interruption Notification: Introduces a requirement for manufacturers to notify authorities, economic operators, and health institutions in advance of any interruptions or cessations in the supply of IVDs or medical devices that pose a risk to patients.

Transition Periods for IVDs: Sets new transition periods based on the risk class of in vitro diagnostic medical devices (IVDs):

  1. High-risk class D IVDs: until December 31, 2027.
  2. Medium and low-risk IVDs (classes C and B): until December 31, 2028, and December 31, 2029, respectively.

Re-establishing IVD Medical Devices Documentary Repository

System Correction: The issue affecting access to product instructions with subject code 80204 has been resolved.

File Restoration: Previously inaccessible files have been restored.

New Submissions: Future submissions under this subject code should not encounter issues. Companies should verify their files and report any errors through official channels.

MD and IVD Regulations Amendment Decree Enacted

IVD Regulation Transition Periods: The transition periods for the In Vitro Diagnostic (IVD) regulation have been adjusted.

Eudamed Database Implementation: Progress is being made step by step in implementing the Eudamed database.

Reporting Obligation for Supply Interruptions: Manufacturers must report to authorities six months in advance if they anticipate an interruption in the supply of a device that could cause serious harm to patients or public health. This requirement starts on January 10, 2025.

TCOKKA - About Regulation (EU) No. 2024/1860

High-Risk IVD Availability: Measures are in place to reduce the risk of high-risk in vitro diagnostic medical devices (IVDs) being unavailable on the market, provided certain conditions are met.

EUDAMED Modules Implementation: Gradual mandatory use of EUDAMED modules will begin from the last quarter of 2025, following their functionality declaration.

Supply Interruption Notification: A new obligation requires prior notification of devices posing a serious risk to patients or public health if their supply is anticipated to be interrupted.

Learn more about EU Medical Device Registration.

CHINA

Clarification on Requirements for Radiofrequency Therapeutic Devices

Strict Regulation of Class III Devices: From April 1, 2026, radio frequency devices that cause changes in human tissues and cells must have a medical device registration certificate to be produced, imported, or sold.

Grace Period for Existing Products: Products with a Class II registration before Announcement No. 30 in 2022 can remain valid until their registration expires or March 31, 2026, whichever comes first.

Guidance and Training for Enterprises: Regulatory authorities will provide targeted guidance and training in product performance, inspection, testing, and clinical evaluation to support the registration of Class III devices.

NMPA Announces Amendments to Medical Device Standards (No. 83 of 2024)

The amendments to two medical device industry standards, including YY 0167-2020 "Non-absorbable surgical sutures" and YY 1116-2020 "Absorbable surgical sutures," have been approved and published.

The details and implementation dates of these amendments are provided in the attachments.Attachments: Amendment No. 1 to YY 0167-2020 "Non-absorbable Surgical Sutures"Amendment No. 1 to YY 1116-2020 "Absorbable Surgical Sutures."

NMPA Strengthens Supervision of Online Medical Device Sales

Strengthening Laws and Regulations: The NMPA issued the "Regulations on the Supervision and Administration of Medical Device Online Sales" in 2017, outlining obligations for online sales companies and platforms. This was revised in 2021 to further reinforce management systems and supervision.

Innovative Regulatory Techniques: A medical device online sales monitoring platform was developed to handle the virtual and cross-regional nature of online sales. This platform supports a closed-loop system for monitoring and feedback, and coordinates reporting and disposal of illegal activities across national and regional levels.

Promoting Social Co-Governance: The NMPA established an alliance with third-party platforms to regularly report on sales, monitor public opinion, and manage complaints. This alliance helps investigate risks, ensure compliance, and implement responsibilities of platform companies.

Learn more about China Medical Device Registration & Approval.

MEXICO

COFEPRIS Authorizes Clinical Trial for Synthetic Cornea Device

New Treatment Alternative: The GORE synthetic cornea device offers a potential new solution for corneal clarity loss.

Current Treatment Limitation: Corneal transplants are the only current treatment for this condition.

Broader Impact: This trial is part of 14 recently authorized trials and contributes to the approval of 76 medical devices and 20 drugs, ensuring high safety, quality, and efficacy standards.

Learn more about COFEPRIS Mexico Medical Device Registration.

Subscribe to newsletter
Subscribe to receive the latest blog posts to your inbox every week.
By subscribing, you agree to our Terms and Conditions.
Thank you for subscribing!
Oops! Something went wrong while submitting the form.
Read more

Latest News

Browse our news hub featuring company announcements, regulatory updates, and industry insights to keep you informed and ahead of the curve.

Regulatory Update
November 13, 2024

This week, we bring you medical device regulatory update coverage from around the world, including new registration Q&A resources in Taiwan and Japan, UK relaunches ILAP pathway, Mexico will apply a new acquisition model, and more.

Regulatory Update
November 6, 2024

This week in medical device regulatory news, EU parliament moves toward a revision of the EU MDR, the UK enhances post-market surveillance requirements, US FDA prioritizes guidance revisions for 2025, and more.

Regulatory Update
October 30, 2024

Peru joins IMDRF, updated clinical trial guidance in Denmark, Romania implements new compliance requirements for professionals users, and more in this week's medical device regulatory update.

A necessary evil of a medical device company’s post-market responsibilities.

Contact us
Request information

Let's Talk,
Anywhere You Are.

Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.

Our closest representative will get back to you within 24 hours.
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.

Latest Blog Content

Explore our collection of articles, success stories, and regulatory updates, designed to help you take your product global.

Blog Article
EU Parliament Revises MDR and IVDR

On October 23, the European Parliament adopted a resolution revising specific elements of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Devices Regulation (IVDR). This resolution intends to address ongoing challenges in implementing the regulations by 2025 and to improve patient access to important medical products.

Blog Article
Language Challenges in MedTech Going Global and Our Solution

Multilingual documentation presents ongoing compliance and logistical hurdles for MedTech manufacturers. Transla.Ai is an industry-specific translation tool that can accelerate and streamline the translation process.

Medical device supply chain
Blog Article
Managing your medical device supply chain

The connection between supplier controls and business risks is becoming increasingly evident. In this article, we discuss perspectives on how to maintain a compliant medical device supply chain.

Blog Article
Brazil: Adapting to Evolving Regulatory Markets

Brazil aligns medical device regulations with global standards, including Europe and the US. Recent updates and international compatibility attract manufacturers.