Mexico has a population of 115 million people and is the fourth-largest device market in the Americas. This is a favorable market for Medical Devices because the country relies heavily on imports.
Ipsumedical has successfully obtained 70+ registration approvals for our clients. Our integrated regulatory, technical, and clinical team can help you prepare the required documents, to accelerate your process for registering your product in Mexico.
Before you start your registration process, you will need to appoint a registration holder in Mexico. This representative coordinates your device submissions and acts as the regulatory liaison between you and Cofepris.
Ipsumedical acts as Mexico Registration Holder for 40+ international manufacturers. This service is offered in three modalities:
1) Ipsumedical acts exclusively as your Registration Holder,
2) Besides acting as your Registration Holder, Ipsumedical is also your Mexico importer and provider of warehousing services and
3) Besides acting as your Registration Holder and importer, Ipsumedical is your commercial master distributor.
Ipsumedical is the only Mexico company able to offer to International Medical Device product owners a choice from a complete set of services, which can be selected and/or mixed in any form, so that you have all the options, at your discretion.
Mexico Medical Devices are regulated by the Health Agency Cofepris, a division of the Ministry of Health. Cofepris reviews all Device registration applications and monitors the safety of the Medical Devices sold in Mexico.
Like most countries, Mexico groups Medical Devices according to the risk level they may pose to patients and users and this classification scheme determines the Regulatory pathway. Mexico groups Medical Devices into four classes of increasing risk as follows: Class I Low Risk, Class I, Class II, Class III. Regardless of the classification imposed on your Medical Device in other territories, Ipsumedical´s Regulatory Affairs Specialists will carefully review your product, classify it according to the specific Cofepris rules, and will recommend the most appropriate registration path and strategy.
Manufacturers of Class 1, 2, and 3 medical devices need to show compliance with ISO 13485 or an equivalent Quality Management System Certification. While Mexico does have its own quality system requirements no audit will be performed on foreign manufacturers beyond the review of the documentation just mentioned. if your device has been tested to an international standard for approval in another market, those testing reports would be accepted as part of your submission in Mexico
An important part of the registration process involves the preparation of a Technical Dossier which includes information on the safety and efficacy of the device plus testing reports. Clinical trial data conducted outside Mexico is acceptable. Manufacturers with U.S., Canadian, or Japanese approval can go through an equivalency process.
Simple class 1 low-risk device manufacturers don't need to prepare a technical file but must submit basic device information to Cofepris. All submitted materials must be translated into Spanish.
Once compiled, your Registration Holder will submit the technical dossier to the Health Agency Cofepris or if you are not leveraging your U.S., Canadian, or Japanese approval you can submit it to a third-party reviewer. If all goes well, Cofepris will issue a Certificate and post confirmation of your registration on the Ministry of Health website. Your certificate is valid for five years as long as you don't make substantial changes to the product, claims, or its intended use.
Timelines A summary of Registration Terms for different Class/pathways follows. These terms are based on our experience throughout the years and they start when your registration dossier has been filed to Cofepris.
While the registration dossier has already been submitted to Cofepris and a response is being awaited, you may receive a notification requesting further information and/or documents. This is what is called "Prevention". The notification from Cofepris must be duly answered between 10-35 working days since otherwise the whole process is canceled, and the registration dossier must be re-submitted.
Ipsumedical as your Registration Holder, and because of our constant and direct communication with Cofepris, will always be notified and provide a response on due time. We have never missed a term with Cofepris.
Once the response to a Prevention has been provided to the Health Agency, the registration process continues normally.
Cofepris Renewal application must be submitted 6 months before the certificate expiration date for no change renewal. Cofepris is very strict about their rules and regulations. We are a certified legal agent in Mexico and have helped many clients with their renewals, modifications, or new applications.
With strong expertise in both post-market surveillance (PMS) and Quality Management System (QMS) requirements, Ipsumedical Team can help you handle all the PMS issues long after your device is on the market, including Techno Vigilance Report (TVR), Adverse Event (AE)/Serious Adverse Event (SAE), recall, inspection, reporting, etc. We can also provide QMS establishment service by evaluating key QMS documents, conducting QMS assessment, design, and implementation, etc.
In Mexico, medical device adverse events (AE) refer to various harmful events that may occur in the normal use of approved medical devices that have caused or may cause human injury. Ipsumedical as your Mexico Agent agent helps by collecting adverse event data and report to Cofepris, cooperate with Cofepris to investigate, analyze, and evaluate the AE.
Ipsumedical’s seasoned post-market surveillance professionals can also help you handling your whole recall process in Mexico, including coordinating communication during a recall, reporting to Cofepris according to your decision and comments, etc.
COFEPRIS is the arm of the Mexican government that sets Mexico medical device/IVD regulations. All medical devices/IVD’s imported into Mexico must be registered in the COFEPRIS national office. Domestic medical devices could be registered in the COFEPRIS provincial office.
CMDE (Center for medical device evaluation) is the medical device registration dossier reviewing center under NMPA (CFDA). There are 6 departments in CMDE. Each one is responsible for reviewing registrations of different categories of medical devices//IVD’s.
• Class I: The safety and effectiveness of Class I medical device/IVD can be ensured by normal administration.
• Class II: The safety and effectiveness of Class II medical device/IVD should be controlled.
• Class III: Human implants; life support and substance; have potential risk to the human body; the safety and effectiveness need to be controlled strictly.
Class I Filing:
1. Class I medical device/IVD filing form
2. Safety risk analysis report
3. Technical standard
4. Product testing report
5. Clinical evaluation materials
6. IFU and minimum selling unit label design sample
7. Production information
8. Legal documents
Class II & III Registration
1. Application Form
2. Legal documents
3. Medical device/IVD safety and effectiveness basic requirements list
•Model and specification
•Clinical indication and contraindications
•Referred predicate product
5. Research Materials
•Product performance research
•Biocompatibility evaluation research
•Sterilization and disinfection process research
•Shelf validity period and package evaluation data
6. Manufacturing Information
•Production process of active/inactive device
7. Clinical Evaluation Materials
8. Product Risk Analysis Materials
9. Product Technical Standard
10. Product Registration Testing Report
11. IFU and Label Sample
12. Self-declaration Documents
In almost all situations for Class II and Class III devices, the COFEPRIS will request samples for type testing. The testing centers will use the product standard to determine what tests to conduct.
For Class II and Class III devices, the COFEPRIS will request samples for type testing. For Class I products, COFERPIS will accept a company’s foreign testing data.
• Testing centers will test all specification items listed in the Product Technical Specifications (YZB Product Standard which is drafted by the company).
• For each specification item, testing centers will utilize the testing method described in the Product Technical Specifications.
• While conducting the tests, the COFEPRIS requests that testing centers provide comments on the company’s drafted Product Technical Specifications.
• The comments from the testing center should be submitted together with the testing report to avoid repeats and additional testing, which occurs frequently, leading to long delays in the registration process.
The testing report will be issued by a COFEPRIS certified national testing center, which can be freely selected from the authorized list. It is only valid for 1 year, and once it expires, a company must start again to obtain a new valid testing report.
Clinical trials must be conducted for all Class II & III medical device/IVD registrations except in the following situations:
• The product has a clear working mechanism, finalized design, and mature production technology. A medical device/IVD of the same variety is already on the market and has been used in clinical practice for many years without any record of serious adverse events. There will also not be any changes to the product’s conventional usage.
• The safety and efficacy of the product can be proven through non-clinical evaluations.
• The safety and efficacy of the product can be proven through the analysis and evaluation of data obtained from clinical trials or clinical application of other medical devices of the same variety.
Yes. You need approval from either the country of origin or the country where the applicant is located to start the COFEPRIS registration process.