On October 26, 2010 COFEPRIS (the Federal Commission for Protection against Sanitary Risks, of the Mexican Health Authority) officially announced the equivalence agreement to be applied to medical devices (including in-vitro diagnostics) that are commercialized in US and Canada. The terms of the agreement took effect November 25th.
The intent of the agreement is to expedite access to safe and effective medical devices for Mexican citizens. Since a considerable number of medical devices sold in Mexico are authorized in the US and Canada and the safety standards of these countries are recognized to be equivalent to those of the General Health Law of Mexico, COFEPRIS will recognize authorization in these countries as sufficient proof of safety and efficacy.
We have translated and studied this document, available in Spanish on the COFEPRIS website. The main points of the agreement are:
- The agreement will apply to the following medical devices:
- Class I, II and III permitted, cleared, or approved respectively by the FDA (Food and Drug Administration)
- Class II, III and IV registered with HC (Health Canada)
- Mexican Sanitary Registrations will be issued within 30 days for all medical devices included in this agreement
- The submission requirements are:
- A detailed summary of the product
- For FDA authorized products:
- Class I must present: CFG (Certificate to Foreign Government), latest inspection report, and an FDA report that describes the medical device classification
- Class II and III must present: CFG, latest inspection report, FDA report that describes the medical device classification, and a summary of post-market surveillance history
- For HC cleared products:
- Class II, III and IV must present: HC Medical Device license, ISO 13485 CMDCAS, and a document stating that HC approved the registration
Many of the practical applications of this agreement have yet to be determined; COFEPRIS offered the following clarifications in a recent public conference:
- The agreement will be applicable to products that are commercialized in the US and Canada and, hence, have been authorized by the FDA and/or HC.
- HC Class I products will not be eligible for the provisions of this agreement and will have to follow the ordinary process. (For Class I devices also authorized in the US, registration under the agreement may be feasible.)
- Although the agreement states that it would become effective on November 25th, documents cannot be submitted until the administrative procedures are accepted (we expect this to closely follow the publication date of this article).
- Initial submissions might expect a response within 6 months. Once COFEPRIS develops experience with this new regulatory system, we expect the timeframe to be closer to that specified in the agreement of 30 days.
- This agreement will not apply to products considered pharmaceuticals in the US or Canada.
In conclusion, although still unclear on certain points, the new agreement will be an important consideration for any company that commercializes medical devices in US and/or Canada and would like to enter the Mexican market. More information on these reforms is available on the COFEPRIS website.