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.
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.
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.
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.
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.
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"
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.
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.
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.
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):
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