Weekly Regulatory News: Nov 11-12, 2024
This week in medical device regulatory news, Thailand has introduced new refer and transfer guidelines, Europe released an updated Q&A on IVDR and MDR vigilance terms, and Romania has new rules for Economic Operators.
THAILAND
Streamlining Medical Device Licensing: New Guidelines for Refer and Transfer Processes
The TFDA has introduced updated guidelines (link in Thai) for the Refer and Transfer processes in medical device licensing. These changes aim to enhance transparency and compliance while ensuring public safety. Below are the details of the processes, requirements, and restrictions.
Key Processes
| Aspect | Refer | Transfer |
|---|---|---|
| Original Dossier | Must be registered in Full CSDT route. Partial registration requires Full CSDT compliance. | Must be registered in Full CSDT route. Partial registration requires Full CSDT compliance. |
| Imports | Medical device from both original and new dossiers must be produced by the same physical manufacturer and under the same product owner. | Name and address of the physical manufacturer and product owner must remain unchanged. |
| Local Manufacturers | Both medical devices must be registered by the same manufacturing establishment. | Manufacturing location must remain the same. |
| License Status | Active | Active |
Required Documentation
Both processes require a similar set of core documents, with some additional requirements.
| Document | Refer | Transfer |
|---|---|---|
| Device labeling | Yes | Yes |
| Instructions for Use | Yes | Yes |
| Executive Summary | Yes | Yes |
| Declaration of Conformity | Yes | Yes |
| Letter of Authorization (for importer only) | Yes | Yes |
| Letter of Consent for Refer/Transfer of Dossier | Yes | Yes |
| Safety Declaration | Yes | Yes |
| Declaration of Identically for Refer/Transfer | Yes | Yes |
Prohibited Cases
Certain scenarios are not eligible for Refer or Transfer processes:
| Condition | Refer | Transfer |
|---|---|---|
| History of problems or serious incidents | Not allowed | Not allowed |
| Concerns about quality, efficacy, or safety | Not allowed | Not allowed |
| Methamphetamine test kids in urine (specific cases) | Not allowed | N/A |
Conclusion
These guidelines provide a clear framework for managing brand name changes (Refer) and ownership transitions (Transfer) in the medical device sector. By setting strict requirements and prohibiting cases with safety concerns, the authority ensures regulatory compliance while prioritizing public health.
Manufacturers and stakeholders are encouraged to review the complete guidelines to facilitate smooth licensing transitions.
Learn more about TFDA Thailand Medical Device Registration.
EUROPE
MDCG 2023-3 rev.1: Updated Q&A on Vigilance Terms for MDR and IVDR Compliance
The European Commission’s Directorate-General for Health and Food Safety has released an updated guidance document, MDCG 2023-3 rev.1, providing a comprehensive Q&A on vigilance terms and concepts under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). Published on November 11, 2024, this document aims to ensure a unified understanding among competent authorities, economic operators, and other stakeholders for effective implementation of vigilance requirements. The guidance aligns terminology with current regulations and incorporates modifications from earlier Medical Devices Vigilance System guidelines. It applies broadly to medical devices, in vitro diagnostic devices, and accessories, ensuring harmonized compliance across the EU.
Learn more about EU MDR and IVDR consulting.
ROMANIA
Romania Announces Updated Operating Rules for Medical Device Economic Operators
The National Agency of Medicines and Medical Devices in Romania reminds economic operators involved in the import, distribution, installation, and maintenance of medical devices about compliance with OMS no. 566/2020. This regulation sets the framework for approval under Title XX of Law no. 95/2006 on healthcare reform. Operating approvals are valid for three years, provided no significant changes affect the original conditions. Operators must ensure timely renewal to avoid disruptions in their activities. The announcement emphasizes the need for adherence to these regulatory requirements for continued authorization.
Device Type · Jul 20, 2026Aesthetic Devices Regulation: FDA, EU MDR & Global GuideDevice Type · Jul 20, 2026Cardiovascular Devices Regulation: FDA, EU MDR & GlobalBlog · Aug 24, 2026Medical Device Registration Verification 2026Blog · Aug 17, 2026Coronary Stents: Eight Highest-Tier FilesBlog · Aug 10, 2026Surgical Robots: Eight Markets, Eight Regulatory FilesBlog · Aug 3, 2026ISO 10993-1:2025: One Core, Seven Regulatory SystemsVideo · Dec 30, 2025Pure Global’s Year in Review 2025Video · Jul 25, 2025Global Expansion Strategies for Medical Device Manufacturers: How to Align Commercial Growth with Regulatory SuccessLet'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.
Contact us