On August 9, 2023, the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), the Mexican governmental body in charge of the regulation of Medical Devices, updated the Guía De Criterios Para Clasificación de Modificaciones de Registros Sanitarios de Dispositivos Médicos by defining types and impact of product or organisational changes on premarket registrations.
The initial part of the document clarifies the concepts of Legal Manufacturer and Real Manufacturer. Specifically, the Legal Manufacturer is the natural or legal person responsible for the safety, performance, quality, design, manufacture, assembly of a system, or modification of a medical device before it is marketed, regardless of whether these activities are carried out by the same person or by a third party. Whereas the Real Manufacturer is the natural or legal person responsible for the production and assembly of a device, i.e., the actual manufacturer or contract manufacturer.
Turning to the substantive content of the guideline, here are some of the main innovations:
- Changes made to a device affecting raw materials, components and significant changes that impact on the intended use shall not be handled as amendments but shall require a new registration process.
- Changes shall be handled according to the original registration route, i.e., proven to be handled in accordance with U.S. requirements if the submission was based on a 510(k) procedure, in an equivalent manner for the Canadian or European regulatory system.
- It is specified in more detail what is meant by an administrative, technical and Registration Holder change, which includes the possibility of changing the importer and/or distributor if this is stated on the label and duly communicated to those concerned.
- As regards the documentation, change of the company name of the registration holder, change of distributor or more simply of its address, change of the company name and/or address of the Real Manufacturer or Legal Manufacturer, change of the trade name or catalogue number of the product, change of secondary packaging material and removal of distributors and/or manufacturers must be supported by confirmatory documentation such as the issuance of appropriate certification by the relevant body and the submission of new GMP (Good Manufacturing Practice) certificates.
By updating and modifying some aspects of the guideline, COFEPRIS shows its intention to make the Mexican market attractive to an increasing number of manufacturers, importers and distributors, making the regulatory system clearer and more manageable, even after significant and non-significant changes.
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