Regulatory Update COFEPRIS ensures resolutions within 24 hours for some modifications to medical device registrations (updated)

This article was first published in December 2023 and updated in March 2024.

COFEPRIS reduces turnaround times and ensures resolutions within a 24-hour timeframe for some modifications to medical device's sanitary registrations.

Update

Starting December 6th, 2023, Cofepris will resolve some modifications to a sanitary registration within 24 hours, as these changes do not impact the safety of the products.

In addition, on February 22, 2024, Cofepris expanded the scope of the modifications to include changing secondary packaging, spelling corrections to an issued registration, and changing the catalog number or product code.

Applications must be submitted with the necessary physical documentation and the corresponding submission code (homoclave).

This update complements the Guide on Criteria for the Classification of Modifications to Sanitary Registration Conditions published on December 2023 (see in Sources).

The following changes will apply to the following products and should be resolved in the priority lane (Ventanilla de Atención Inmediata):

Class I, II, and III devices

  1. Legal entity name of both the legal and real manufacturer

  2. Elimination of codes or presentations, national distributors, and real manufacturer

  3. Legal company name or address, and inclusion or removal of an overseas distributor

  4. Change of secondary packaging. (Update Feb 22)

  5. Spelling correction outside the time frame of an Internal Correction. (Update Feb 22)

  6. Change of catalog number or product code. (Update Feb 22)

Low-risk devices

  1. Address of national or foreign distributor

  2. Legal company name of the owner, manufacturer, or distributor

  3. Authorized distributor in national territory

  4. Legal company name and address of the legal manufacturer

  5. Commercial name or product catalog number

  6. Secondary packaging material

  7. Deletion of presentations

  8. Removal of distributors and the real manufacturer

  9. Spelling correction outside the time frame of an Internal Correction. (Update Feb 22)

  10. Change of catalog number or product code. (Update Feb 22)

Regulatory framework

  • Regulation of health products

  • “AGREEMENT by which are modified various procedures and services, as well as the formats applied by the Ministry of Health, through the Federal Commission for the Protection against Sanitary Risks, registered in the Federal Commission for Regulatory Improvement, published on January 28th, 2011 and the various formats by which the procedures in charge of the Ministry of Health that are indicated, published on September 2nd, 2015"

  • Criteria that the supporting documentation and information must meet to request modifications to the conditions of the sanitary register of Medical Devices

Effects from the RA update

Starting December 6th, 2023, the administrative modifications described in this update shall be submitted through a priority lane (Ventanilla de Atención Inmediata) and resolved within 24 hours. Likewise, new administrative changes have been added starting February 22, 2024.

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