Weekly Regulatory News: Nov 11-12, 2024

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.