COFEPRIS procedures are authorizations issued by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) and ensure that healthcare facilities, such as hospitals and laboratories, comply with existing health regulations and requirements. The procedures are carried out in person at the COFEPRIS offices in Mexico City or through the COFEPRIS Comprehensive Service Centers in other federal entities.
Sanitary Permits
The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) grants various sanitary permits related to the construction, remodeling and equipping of medical facilities. It is important that hospitals and clinics obtain these permits to ensure the safety of patients and health professionals.
To obtain these permits, a hospital or clinic must submit several documents such as a permit form, a medical-architectural program and paper plans. They must also include two witnesses whose official authority is outside the ratified State.
COFEPRIS has the mandate to treat personal data responsibly, in accordance with the General Law on Personal Data Protection. Likewise, your data will not be sent to third parties. The institution must have access to your personal information. The use of OECD services after obtaining it must be for competition purposes, notifications and risk investigation. It will not be used for other judicial, commercial or any other type of purposes.
Certificate of Good Practices
The Certificate of Good Practices is a document that the Fiscalization Division of the MSP grants to health product companies regarding the registration of manufacturing plants. To obtain this document, the company must have the Technical Director or Legal Representative authorized and a technological audit committee included in the process.
The objective of the committee will be to verify to what extent the company’s establishments use manufacturing technology to produce high quality products. This committee must also analyze the capacity of the equipment and personnel in charge of the manufacturing process, as well as their guarantee testing systems.
COFEPRIS grants other documents such as the Sanitary License, allowing health service establishments such as hospitals and clinical analysis laboratories to act.
Permits for Activities
A COFEPRIS procedure is a formal procedure by which individuals or companies request authorization, registration, permits and licenses for products, services or activities that may pose a risk to public health. Regisan offers a wide range of tramites de COFEPRIS services to help you comply with the standards established by Mexican sanitary regulations and avoid unnecessary costs and delays in the completion of your procedures.
Food supplements are a vital part of a healthy diet. To promote them in Mexico, you must secure permission from COFEPRIS (Federal Commission for Protection against Sanitary Risks). This can be a complicated process and understanding how to obtain approval is essential to ensure your product is compliant with regulatory requirements.
You can apply for a permit online, at COFEPRIS Integral Service Centers, or at the public service counters of State Commissions for Protection against Health Risks or of health regulation offices in your region. Applicants also have the option of submitting applications by courier.
Certifications COFEPRIS, the Federal Commission for the Protection against Sanitary Risks, ensures the quality of health products. This includes medicine, medical devices and other health-related products. This vital agency oversees the manufacturing, distribution, and exporting of these products. It also certifies and approves manufacturers, plants, and exporters.
COFEPRIS offers a range of certifications including GMP certificates and approvals, warehouse licenses, etc. All of these are regulated by the Agency and can be obtained via its digital platform called DIGIPRiS. The platform enables a faster and more efficient management of these applications, and reduces administrative burden on the Agency.
In the past, each application had to be printed and submitted in physical copies. DIGIPRiS allows this process to be completed electronically, saving valuable time and resources. The platform will also allow changes to be made to an existing certificate or permit, such as modifications to distributors, formulas and raw materials. A new inspection may also be required due to a change in device classification, manufacturing site or shelf life.