Weekly Regulatory News

MEXICO

New Agreement to Strengthen Good Manufacturing Practices for Pharmaceuticals and Medical Devices in Mexico

COFEPRIS has introduced new guidelines to ensure compliance with Good Manufacturing Practices (GMP) for pharmaceuticals, medicines, and medical devices entering the Mexican market. The agreement focuses on the documentation required for new registrations, extensions, and modifications.

Key provisions include:

• GMP Certificate Validity: Foreign-issued GMP certificates must be apostilled or legalized and verifiable by COFEPRIS. Translations are required for non-Spanish/English documents.

• International Recognition: COFEPRIS accepts GMP certificates from internationally recognized regulatory authorities.

• Validity Period: GMP certificates are valid for 30 months from the inspection or issuance date.

• Document Verification: COFEPRIS will verify documents through official platforms for transparency.

Accepted Documents for Medical Devices:

• MDSAP Audit Certificate (ISO 13485)

• GMP compliance certificates from recognized authorities

• CE certificates for medical devices

Benefits:

• Patient Safety: Ensures high-quality, safe medical devices.

• International Recognition: Facilitates global market access.

• Efficiency: Electronic verification improves process speed.

Challenges:

• Costs: Certification and legalization can be costly, especially for small businesses.

• Regulatory Dependence: Delays may occur if foreign authorities are unavailable.

Conclusion:
These guidelines align with international standards to improve the quality and safety of products in the Mexican market, enhancing competitiveness while posing challenges for smaller manufacturers.

Link to the original document: DOF Official Document

Learn more about COFEPRIS Mexico Medical Device Registration.

BRAZIL

ANVISA Cancels Notifications for "Equipment Cleaning Solutions" Under New IVD Regulation

ANVISA has published an update announcing that notifications for products previously regulated as "equipment cleaning solutions" are being canceled to align with RDC No. 830/2023. According to the new regulation for in vitro diagnostic (IVD) medical devices, these products are now classified as low health risk and no longer require notification to ANVISA.

This change applies to cleaning solutions used in the maintenance of IVD instruments, such as those for washing cannulas and tubing. Since they are now considered low-risk, these products can be freely marketed without regulatory notification. However, cleaning products used for non-IVD purposes will still be classified as sanitizing agents and must comply with the relevant regulations. This adjustment aims to streamline the regulatory process while ensuring compliance with the updated standards.

Learn more about ANVISA Brazil Medical Device Registration.

EUROPEAN UNION

New Guideline for Clinical Evaluation Consultation Procedure (CECP) for High-Risk Devices

On March 18, 2025, a new guideline was published for certain high-risk Class D (or Class C) medical devices that must undergo the Clinical Evaluation Consultation Procedure (CECP). This guideline, issued by the expert panels on medical devices and in vitro diagnostic devices (Expamed), outlines the requirements for the CECP as per EU regulations.

The CECP focuses on evaluating clinical data, benefit-risk assessments, and Post-Market Clinical Follow-up (PMCF) activities. Independent experts, as outlined in Article 106 of the MDR, must assess the clinical strategy and evidence provided by manufacturers for these high-risk devices. The guideline emphasizes the importance of robust clinical evidence to support the safety and efficacy of these devices in the European market.

Link to full guideline: CECP Expert Opinion

Update on SARS-CoV-2 Classification: Down Classification from Class D to C and B

The recent update to MDCG 2020-16 Rev. 4 introduces a key change in the classification of SARS-CoV-2 testing devices. Following recommendations from the Team Notified Body in February 2024 and scientific advice from the IVD Expert Panel (EMA) in January 2025, SARS-CoV-2 tests have been officially down classified from Class D (highest risk) to either Class C (self-testing devices under Rule 4(a)) or Class B (professional-use under Rule 6). This reclassification reflects the reduced life-threatening risk and mortality rate of SARS-CoV-2 for the general European population. The MDCG guidance has been updated accordingly to reflect these changes.

Learn more about EU Medical Device Registration.

CHINA

2025 National Medical Device Sampling Inspection Plan Issued by the National Medical Products Administration

On March 26, 2025, the General Office of the National Medical Products Administration (NMPA) issued the 2025 National Medical Device Sampling Inspection Product Inspection Plan (Drug Administration General Medical Device Administration [2025] No. 28). This plan outlines the requirements and guidelines for the inspection of medical devices in China, detailing mandatory standards, technical requirements, and procedures for inspection.

Key points include:

• Inspection Work Requirements: Drug Administrations across provinces and regions must organize inspections of medical devices according to national standards and registered product specifications.

• Re-inspection Procedures: Provincial drug supervision departments are responsible for processing re-inspection applications and selecting agencies to carry out re-inspections, ensuring transparency and fairness in the process.

• Handling of Inspection Results: If products fail to meet the inspection standards, risk control measures must be immediately implemented, and further investigations will be carried out as necessary, including legal actions if required.

The plan aims to strengthen regulatory oversight and ensure the safety and quality of medical devices available in the Chinese market.

Learn more about China Medical Device Registration & Approval.

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