What is the COFEPRIS Health Registry?
The COFEPRIS Health Registry in Mexico is an official authorization issued by the Federal Commission for the Protection against Health Risks, which certifies that a product complies with the health regulations necessary for its sale and distribution in Mexican territory. This registration is essential for products such as medicines, medical devices, dietary supplements, processed foods and beverages, cosmetics, and personal hygiene products, among others.
Obtaining a Health Registration implies that the product has been evaluated and approved by COFEPRIS in terms of its safety, efficacy, and quality, based on the scientific and technical evidence presented by the applicant. This process includes reviewing information such as formulation, labeling, instructions for use, and data from clinical studies or laboratory tests, depending on the product category.
The main functions and benefits of the Health Registry are:
- Public Health Protection: Ensures that the products available on the market are safe for consumption or use by the population, thus minimizing health risks.
- Market Regulation: Establishes a legal framework for the marketing of regulated products, promoting fair and competitive practices within the sector.
- Consumer Confidence: It offers consumers the guarantee that the products they purchase have been evaluated and meet quality and safety standards.
- Market Access: The Health Registry is a requirement for the marketing of regulated products in Mexico, and is often a criterion for participating in public tenders or entering important commercial chains.
- Legal compliance: Complies with legal and regulatory obligations, avoiding sanctions, fines or the prohibition of marketing the products.
How to Obtain a COFEPRIS Health Record?
The process to obtain a Health Registration before COFEPRIS (Federal Commission for the Protection against Sanitary Risks) in Mexico may vary depending on the type of product you wish to register, such as medications, medical devices, dietary supplements, foods and beverages, cosmetics, among others. others. However, there is a general outline that describes the basic steps involved in requesting this registration:
- Documentation Preparation: The first step is to gather all the necessary documentation for the application. This includes detailed information about the product, such as its composition, specifications, labeling, instructions for use, and evidence of safety and effectiveness, such as clinical studies, stability studies, and laboratory tests, depending on the type of product.
- Compliance with Specific Requirements: Depending on the type of product, specific requirements must be met. For example, medications may require clinical testing, while medical devices may require good manufacturing practice certifications.
- Submission of the Application: Once all the documentation has been prepared, the registration application must be submitted along with the supporting documents to COFEPRIS, through the platforms or mechanisms designated for this purpose.
- Rights payment: Generally, payment of a fee is required to process the health registration. The amount may vary depending on the type of product and its category.
- Review by COFEPRIS: COFEPRIS will review the application to ensure that the product complies with all safety, quality and efficacy regulations and standards. This process may include a detailed technical evaluation of the submitted documentation, inspections of manufacturing facilities, and additional laboratory testing.
- Response to Requirements: It is common for COFEPRIS to make requests for additional information or clarifications on the data presented. Applicants must respond to these requirements within the established deadlines to continue with the review process.
- Approval and Issuance of the Health Registry: If the product meets all the requirements and regulations, COFEPRIS will issue the Health Registry. This document authorizes the marketing of the product in Mexico under the approved conditions.
- Maintenance and Renewal: The Health Registration has a validity period, after which it must be renewed. Additionally, any significant change in the product, labeling, or manufacturing conditions must be notified and, in some cases, approved by COFEPRIS.
It is advisable to consult the official COFEPRIS website and, if necessary, obtain advice from experts in health regulation to ensure correct preparation and submission of the health registration application, given that the requirements and procedures may vary and be updated over time.