Mexico’s COFEPRIS

Mexican Health Authority (COFEPRIS) requires that any foreign pharmaceutical or biologic company, without a physical location in Mexico, to appoint a Mexican Registration Holder in Mexico before registering and selling any product in Mexico. In Mexico, GRP Mexico office is licensed by COFEPRIS to act as your Local Representative in Mexico.

Registering your medical device for sale in Mexico requires approval from the Comisiόn Federal para la Protecciόn contra Riesgos Sanitarios (COFEPRIS), a division of Mexico’s Ministry of Health. Some devices that have previously obtained market authorization in the US, Canada or Japan qualify for expedited review by COFEPRIS. However, registering a device or IVD in Mexico can be challenging. Little information on the registration process is available in English from COFEPRIS, the division of the Mexican Ministry of Health (Secretaría de Salud) responsible for medical device and IVD oversight.

COFEPRIS classifies medical devices into four categories based on risk to the patient. Table 1 summarizes the 4 Device Classes and their associated risk description. Table 2 summarizes various registration pathways for Medical Devices.

• GRP can determine the proper classification for your medical device and can provide an initial assessment on grouping acceptability, if necessary.
• Many manufacturers work with us on standard Third-Party Review submissions, as well as the equivalency route available to certain devices already approved by the US FDA, Health Canada, or Japan.
• Our in-depth knowledge of the Mexican medical device market ensures that we provide the most efficient and cost-effective regulatory approval strategy for your device.
• We can assist you in preparing medical device registration documents that demonstrate compliance with COFEPRIS.
• Our Mexico Registration Holder services allow us to submit devices for COFEPRIS approval on your behalf.

• Assistance with COFEPRIS inspection (if applicable to product)
• Adverse Effect Reporting ( Technovigilance in Mexico)
•  Importation & Clearance in Mexico
• Warehouse and Storage in Mexico
• Distribution
• Organize and support COFEPRIS consultation meetings.
• Recall or incident report assistance

Clinical Trials in Mexico are known as Ensayos Clínicos. Clinical trials authorizations with the purpose of registering a pharmaceutical product are requested based on the type of research, the origin of the product or the research procedure. Applicants may submit the documents to gain authorization to perform Clinical Trials/Human Subjects Research Protocol directly to Cofepris or request a preliminary evaluation report to a UHAP (support units enabled to emit preliminary report).

UHAP Evaluations:

UHAP evaluations are voluntary. Contact method and costs are not standardized among UHAPs. The preliminary report attached to the file submitted to Cofepris may speed up the processing process. Applications including UHAP reports may be issued in up to 30 business days.

• Clinical Trial Consulting Services

  GRP will provide clinical trial consulting services, including consultations with all local government. We can help you develop an effective Clinical Investigation Plan with clinical trial strategy, clinical trial study design, and clinical trial protocol.

• Regulatory Support

  We can assist with clinical trial applications (CTA) and clinical trial notifications (CTN) as required for clinical trial initiation in Mexico. Our on-the-ground teams consist of experienced professionals who will meet with the appropriate  regulatory agencies on your behalf throughout the clinical study. We will provide guidance on meeting the Institutional Review Board (IRB) and Independent Ethics Committee (IEC) requirements.

• Clinical Trials Management
  

  We can comprehensively manage the clinical trials process by conducting the trials and completing the clinical trial reports. Our experts will evaluate clinical trial and non-clinical trial data; conduct gap analyses; and determine safety and efficacy, along with primary and secondary endpoints, as required for your specific product.

• Quality Compliance and Audits

  We can conduct on-site audits of your clinical trials and consult on the guidelines for Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practices (GVP), Good Quality Practice (GQP), Good Manufacturing Practice (GMP), etc.

• Adverse Events and Post Market Surveillance
  

  We will report adverse events and implement suggestions on additional tests and required data. We can assist in post-approval and post-clearance clinical trials to maintain the safety, efficacy, and performance of the product through its life cycle.

Compliance with design control procedures.

The US Food and Drug Administration (FDA) and other market regulators including COFEPRIS require proof of compliance with established design control procedures for some device classifications. It is important to show ongoing compliance all the way from device conception through release to market.

To ensure ongoing compliance with quality system procedures, you should;

• evaluate your pre-production QMS using internal audits at least once a year.
•   Conducting periodic internal audits also supports the evolution of the QMS when new processes are added to the system as the organization approaches launch of the product.

GRP QMS implementation Services:

• Document and records control
• Training on regulatory requirements and internal procedures
• Design and development
• Risk management
• Software development (if applicable)
• Supplier evaluation
• Control of measurement equipment
• Perform internal quality system audits