This article details the process of modifying existing registration entries for medical devices permitted for marketing and use in Mexico.
Table of Contents
Mexico’s medical device regulatory authority, COFEPRIS, has released guidance on changes to the sanitary registry for medical devices. This document outlines regulatory requirements and offers additional guidance for manufacturers and stakeholders to ensure compliance.
It’s important to note that this guidance is non-binding and does not introduce new rules or obligations. The authority may update the guidance as necessary to align with legislative amendments.
The document also provides a comprehensive breakdown of the information required for different types of changes and products.
Administrative Modifications
The document outlines requirements for administrative changes to medical device sanitary registration. These changes cover address, company name, distributor, or legal manufacturer updates.
To meet general requirements, the responsible party must provide:
– A completed modification form.
– Proof of payment per regulations.
– Legal status documents.
– Labeling and user manual details.
– Copy of the sanitary registry and past modifications.
– A notice from the health supply establishment’s operation and/or health manager.
Additional requirements include:
– Change of Address: Include manufacturer/foreign distributor justification, along with supporting documents for address changes.
– Change of Business Name: Provide original or certified name change documents and a notification letter from the manufacturer.
– Change of Authorized Distributor: Include a manufacturer’s representation letter. If not in Spanish or English, provide a translation by an expert translator.
– Change of Legal Manufacturer: Submit legal documentation justifying the change, authenticated by the country of origin, with translation if necessary.
– Representation letter from the new legal manufacturer and a certificate of free sale from the country of origin.
– Change in Trade Name/Catalog Number: Include an original or certified manufacturer’s letter explaining the change.
Technical Modifications
Technical modifications encompass various changes, including those related to radiation sources, manufacturing sites, primary packaging material, non-active ingredient formula changes, expiry date alterations, and new product presentations.
General requirements for technical changes include submitting:
– A completed modification form.
– Proof of payment.
– Legal status documentation.
– Technical, scientific, and legal justification for the modification.
– Labeling plans, user manuals, and official sanitary registry details.
– A sanitary registry project reflecting the requested changes.
Additional requirements in specific cases include:
–Change in Manufacturing Site: Provide a Certificate of Good Manufacturing Practices from the health authority of the origin country or COFEPRIS. Other documents like an “Inspection Report” or equivalent are also necessary.
– Change from Foreign to National Manufacturing Site (or vice versa): Include a certificate of free sale from the health authority of the origin country.
– New Product Manufacturing Sites: Acceptable documents include a letter from the Health Authority of the origin country, documents from the ministry regulating medical devices in that country, clinical study results, etc.
Additional requirements involve certification of good manufacturing practices from either COFEPRIS or the health authority of the origin country.
Other Changes
The document offers a concise overview of regulatory requirements for various types of changes. Here are some examples:
– Change of National Maquiladora: Required documents include a notary-certified copy of the maquila agreement, a Certificate of Good Manufacturing Practices from the Federal Commission for Protection against Sanitary Risks, and a certificate of analysis or quality report for the finished product.
This report should include product details, lot or serial numbers, specifications, acceptance parameters, and results.
– Reclassification Based on Health Risk: To justify reclassification, provide a detailed explanation, including a product description.
– Changes in Packaging Material: Submit a stability study report covering shelf life or expiration date, along with detailed primary and secondary packaging descriptions. Include information on materials used and how they ensure product stability or sterility, if applicable.
– Changes to Expiry Date: In addition to the above, provide a stability or aging study report.
In summary, COFEPRIS’s guidance outlines the regulatory requirements for modifying existing product registrations based on the nature and impact of the changes. It specifies the required documentation for medical device parties and highlights key considerations.
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