Considering Mexico as the second largest medical device market in Latin America, you may find it as a good alternative to expand your business. Nevertheless, there are a few considerations to register your products in the country. In this brief overview, we will describe what you need to register your medical device in Mexico and some key facts to take into account making this process easier for you and your team.
Medical Devices in Mexico are regulated by COFEPRIS (COmisión FEderal para la Protección contra Riesgos Sanitarios), a Federal Commission that belongs to the Ministry of Health.
Most of the times, a medical device in other countries is also considered a medical device in Mexico. Nevertheless, it is necessary to confirm the classification and grouping through local legal guides. This is the first step we recommend you to take.
In addition, there is an option to work with Third Party Reviewers. These are COFEPRIS approved entities that deliver a pre-approval. COFEPRIS considers this pre-approval as a proof that another expert has evaluated the dossier resulting in an expedited review and response. An option if you want to have timeframe certainty or agile feedback.
As in other countries, there are different regulatory pathways to register a medical device:
- Standard Process.
- Time: Even though there are official timeframes, you should consider at least 12 months to receive a response.
- Third Party Reviewer: As an alternative, you can choose a Third Party Reviewer. This will take around 3 to 6 months upon submission.
- Third Party Reviewer fee: $2,000-4,000USD depending the reviewer and the device class.
- COFEPRIS fee: $500-1,100USD depending the device class.
- Time: Even though there are official timeframes, you should consider at least 12 months to receive a response.
- Equivalency agreement.
- Applicable for products approved by US FDA, Health Canada (only for Class II-IV) and Japan (only for Class II-IV).
- Time: 8-11 months for FDA and HC approved products and 5-8 months for Japan.
- The option for Third Party Reviewers is not applicable for this route.
- COFEPRIS fee: $500-1,100USD depending the device class.
Holding
In Mexico it is necessary to have a Registration Holder who owns the registration. The Mexican Registration Holder (MRH) also must be a Mexican legal entity.
- Main responsibilities of the holder:
- To be the main point of contact in Mexico with COFEPRIS.
- Apply for any process with COFEPRIS, related with the registrations or any product.
- Report any incidence, in terms of Technovigilance
- Benefits of having a holder as a commercial partner:
- Assign or remove local distributors, avoiding dependence with them.
- Have a local ally, with local presence to oversee your sanitary authorizations.
Post-authorization activities
When the registration is released from COFEPRIS, you are able to sale your medical devices. It is important to consider that any change in the sanitary registration conditions must be notified through a modification process.
On the other hand, the registration is valid for 5 years only and can be renewed for 5 more years.
Finally, in case your medical device is related to an adverse incident, your holder must report it to COFEPRIS. The effective holder’s role in such cases will be determinant for a successful surveillance process.
In conclusion, to have a great experience registering a Medical Device in Mexico, we recommend establishing a strategy, starting with a classification. Then, evaluating the most suitable regulatory pathway (standard, equivalency or third party) and finally consider your post authorization duties. Our last advice is carefully choose your Sanitary Registration Holder. As discussed, this entity plays a major role as your representative in Mexico.
For more information, check similar notes in our Guides.
In case you have any question or comment, please feel free to contact us at contact@veraqueconsulting.com