BRAZIL

New Labeling Rules for Medical Devices: Key Changes Under RDC N° 902:2024

RDC N° 902:2024 introduces new mandatory labeling requirements (link in Portuguese) for products under sanitary surveillance, including medical devices. The regulation requires companies to include statements like "NEW FORMULA" or "NEW COMPOSITION" on product labels when there is a change in composition. Lay-use medical devices must follow specific guidelines outlined in IN N° 68:2020 to ensure compliance.

Key points of the regulation include:

• Inspection Readiness: ANVISA will enforce compliance through inspections based on these updated regulations.
• Uniform Labeling: Harmonized standards ensure clear and consistent labeling for all products with updated formulas.
• Consumer Transparency: New labeling requirements provide clear information to consumers about formula changes, promoting informed decision-making.
• Legal Compliance: Companies must revise labeling processes and packaging to meet the new guidelines.

Pure Global is helping businesses adapt to these changes by revising labels and preparing for regulatory inspections, ensuring full compliance with the new standards.

Transfer of Ownership: Key Updates Under RDC N° 903/2024

The new ANVISA resolution, RDC N° 903/2024 (link in Portuguese), published on September 9, 2024, introduces no changes to the existing procedures and deadlines set by RDC N° 102:2016. However, it reinforces and clarifies the processes for transferring product registration ownership and responsibilities related to clinical trials.

Key points of the regulation include:

• Product Registration Ownership Transfer: Outlines the procedure for transferring product registration between companies, applicable during corporate or commercial operations.
• Clinical Trial Responsibility Transfer: Provides guidelines for transferring clinical trial responsibilities from one company to another.
• Updating Registration Data: Ensures the updating of registration data for companies, especially after mergers or acquisitions.

Main highlights:

• Simplified Procedures: The resolution simplifies and streamlines regulatory processes.
• Revocation of RDC N° 102:2016: RDC N° 903/2024 replaces the previous regulation, maintaining its core elements with improved clarity.
• Exclusive Application: These procedures apply only when the technical and sanitary conditions of companies and products remain unchanged.

How Pure Global can help:

• Impact Assessment: We identify the specific implications of the new resolution for your business.
• Process Adjustment: Assistance in adjusting internal processes for compliance.
• Team Training: Tailored training for teams involved in the ownership transfer process.
• Documentation Management: Support in organizing all necessary documentation.

These updates aim to simplify compliance and enhance operational efficiency. Contact our consultants for expert guidance.

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VIETNAM

New Appraisal Requirements for Class C and D Medical Device Registration

For Class C and D medical devices without a certificate from reference countries, registration now requires (link in Vietnamese) a third-party appraisal of the Common Submission Dossier Template (CSDT). The designated third parties are:

• Non-IVD Devices: Appraisal by the National Institute of Vaccines and Biologicals or a MoH-designated unit.
• IVD Devices: Appraisal by the Institute of Medical Equipment and Works or a MoH-designated unit.

The Institute of Medical Equipment and Works has announced a fee of 19,000,000 VND (~$800) for IVD device appraisals, with a timeline of around three months. The fee notice for non-IVD devices is still pending.

Stay informed to avoid delays in the registration process.

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