MEDICAL DEVICES

We advice you on a fast and effective way to access the market. Submissions to COFEPRIS.

We advice you on a fast and effective way to access the market. Submissions to COFEPRIS.

At IPS, our regulatory affairs services for medical devices are tailored to meet the unique needs of our clients in the industry. Our team of experienced professionals is well-versed in the intricate regulatory landscape surrounding medical devices. Our services include conducting thorough regulatory assessments, preparing and submitting regulatory applications, and ensuring compliance with all applicable laws and regulations. We strive to navigate the complex regulatory requirements efficiently and effectively, helping our clients bring their medical devices to market in a timely manner while maintaining the highest standards of safety and quality.

    • Regulatory Pathway Assessments

    • Inquiries to COFEPRIS

    • Registration of all classes and categories

    • In-country representation (hosting)

    • Administrative and technical modifications

    • Renewals

    • Operating License

Medical Devices must be registered with the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS). In some cases, such as personal use or research, products are exempted from being registered.

In Mexico, you can submit for COFEPRIS approval via the standard review process, authorized third-party reviewer (TPR), or the equivalency agreement. IPS assists with the submissions through all three routes. The route you choose determines your overall project costs and times.

  • This is the straightforward and most common used route in which you submit your application directly to COFEPRIS after gathering all of the legal and technical information. There are certain rules to follow when assembling the dossier so it’s important to be familiar with how COFEPRIS expects to review the information.

    It is also a lengthy review time where we could expect 12-24 for the sanitary authority to finish it’s review, although, we have seen approvals in 7 months.

  • The equivalency agreement is intended to provide Mexican citizens with expedited access to medical devices already evaluated by the US - FDA, Health Canada, and Japan - Pmda. COFEPRIS recognizes its safety standards to be equivalent to those of the Mexican Health Law.

    ⚠︎ Not all products approved by those regulatory agencies can qualify under this route. You’ll need to qualify.

  • TPRs are authorized and audited by COFEPRIS. They aid the sanitary authority with the review process for medical device & drug applications. Their role is also important as they could expedite the approval process since the dossiers are reviewed and submitted to the Mexican regulatory agency pre-approved.

    IPS works with TPRs that have strong confidentiality and anti-bribery clauses in addition to proving fast, high quality, and effective results.

    ⚠︎ Important Update regarding the current situation with TPRs: Until 2018, COFEPRIS approval times for submissions through TPR were between 3 and 6 months. AFTER 2018 and until now, approval times are the same or even more than the standard review process, which is why we don't advise our clients to submit under this route. The priority access that TPRs had in COFEPRIS was also eliminated. In addition, up until 2018, there were 19 Authorized TPRs. Today there are only 6 Authorized TPRs since both the pharmaceutical and medical device industries are not using them anymore.

⚠︎ COFEPRIS times are constantly changing; therefore, our team will keep you updated with the latest estimated approval times in addition to ways to help expedite the process. Since 2020 there has been a considerable backlog for COFEPRIS to review applications.

Categories & Classes

In Mexico, Medical Devices are divided into seven categories and four classes.

    1. Medical Equipment

    2. Prostheses, Orthoses and Functional Aids

    3. Diagnostic Agents

    4. Supplies for Dental Use

    5. Surgical and Healing Materials

    6. Hygiene Products

    7. Software as a Medical Device

    1. Low Risk

    2. Class I

    3. Class II

    4. Class III

Resources

96 Low-Risk Products

(Published 2011)

2,242 Deregulated Products

(Published 2011 & 2014)

Authorized representative registration Holder

Foreign medical device manufacturers can commercialize their products in Mexico by appointing IPS as their in-country representative. Learn more here.

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