Overview
The Mexican regulator, COFEPRIS, published the 5.0 edition of the Supplement for Medical Devices in the Mexican Pharmacopoeia, introducing regulatory requirements for Software as a Medical Device (SaMD).
Pharmacopoeia 5.0: Software and Equivalence:
In addition to the standard shipping route established years ago, there is a system in Mexico with COFEPRIS that takes advantage of other regulatory authorizations, known as the equivalence route. Prior regulatory authorizations from the US FDA, Health Canada and Japan’s MHLW can be used in Mexico. This reduces the amount of documents to be sent and speeds up the analysis time by COFEPRIS.
SaMD permits in May 2024
The press releases (Communication 70/2024 and 72/2024 (links in Spanish)) confirmed that COFEPRIS has announced its first two approvals for SaMDs, both issued under the FDA equivalence route. The first registration is for a SaMD that displays and processes data on aortic and distal blood pressure signals. The second registration was granted for a cardiac monitoring app on smartwatches.
Access to these devices by healthcare professionals and lay users in Mexico would improve the cardiac data provided to patients.
Concluding remarks
We at Global Regulatory Partners share the excitement of the Ministry of Health in Mexico. This is undoubtedly a significant milestone, and we hope to see the number of SaMD approvals with COFEPRIS increase steadily.
Time GRP México Services
- GRP México acts as the official regulatory representative in the country.
- We can fully assist in obtaining Mexican approval for medical devices from COFEPRIS.
- Our experienced consultants are dedicated to the medical device sector.
- GRP BR will cooperate fully with you so that you have complete control of device approval.
- Our expertise and local presence will support you and help you succeed in Mexico.
Learn more about Cofepris
Brochure : GRP Mexico Services
We are a global consulting firm Headquartered in Boston Massachusetts USA that provides Regulatory Affairs, Quality, Clinical and Safety services to pharmaceutical and medical device companies worldwide to register their products with the Mexico's Cofepris the local Health Authority (HA)
Brochure : GRP USA Services
We are a global consulting firm Headquartered in Boston Massachusetts USA that provides Regulatory Affairs, Quality, Clinical and Safety services to pharmaceutical and medical device companies worldwide to register their product with the Food and Drug Administration (FDA) the local Health Authority (HA)
About Global Regulatory Partners Group
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.