Mexico is considered as the second largest market for medical devices in Latin America. In Mexico, the Federal Commission for the Protection against Sanitary Risk (COFEPRIS) from the Secretariat of Health, regulates the Medical Device registrations and related services. Through sanitary regulations, control and promotion under a single command, the Agency aims to protect the population against sanitary risks posed by ineffective and unsafe devices.
COFEPRIS, under the leadership of Lopez Gatell, who leads the response program against the pandemic is adopting major administrative changes. As a ripple effect, the medical device regulations in Mexico have also undergone certain changes. Here we bring to light a few changes introduced by the Agency and their impact on the MedTech industry.
- Ease in Translation Requirements: COFEPRIS now requires “documents to be submitted either in English or Spanish”. Earlier, COFEPRIS required the documents, test or clinical reports, and the dossier to be submitted in Spanish. Further, the legal documents could be translated only by an expert in Mexico. With the new rule, the Spanish translations will no longer be required for technical translations, thereby saving both time and costs for translations. However, this is applicable only for English; other language documents still need to be translated to either English or Spanish.
- Renewal: Earlier the product registration was valid for five (05) years and had to be renewed 150 days before the expiration. This window period for expiration has been increased to 270 days. In contrast to earlier requirements, labels or Certificates of Analysis need not be submitted in renewal submissions anymore. Also, the device now needs one time renewal in entire device life cycle unless there are safety issues with the product. Once renewed, there shall be no expiry date.
- Third Party Reviewers (TPR): Earlier third party could be used for fast-track applications, which is now changing with the new regulations and shall not be applicable with COFEPRIS henceforth.
- Equivalency Route: Mexico has been offering three (03) routes to request a sanitary authorization, with equivalency route, being the fastest Regulatory pathway since 2010. With COVID-19, the Ministry of Health in Mexico has expedited the time frame to respond to a new registration application under its equivalency route. Under this the authority shall take five (05) working days to respond to any new registration request. In case, if it is not resolved within this time, the submission must be considered as granted. This is a significant move considering that previously, in 2010, the time frame was two to three (2-3) months,, which went all the way up to six to eight (6-8) months in recent years.
Apart from the above changes in Regulatory frameworks, there have been few administrative changes. The same shall be evaluated and informed on a case-to-case basis and to specific products. COFEPRIS is making adjustments to few other regulations to be compliant and shall inform about the changes within 90 days. Most likely the techno vigilance norms are expected to undergo changes to be in compliance with the new rules. Finally, there would be other changes that could impact the rights transfer process, but the document is still not clear about it.
On analysing the aspects that impact medical device registration, the above changes seem to ease the language barrier, imposes no expiry on renewals and time for approval. It definitely seems like a boon for companies based outside Mexico and willing to register their medical devices in the Mexican market.
To gain further insights for impact assessment on your device registrations or Regulatory services in Mexico and other LATAM countries, consult a proven Regulatory expert. Stay informed. Stay compliant.