Mexico Blog Posts

Mexican Regulators Set Digital Advertising Recommendations for Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • Mexico’s COFEPRIS has issued simplified guidelines for medical device digital advertising campaign processes.
  • The guidelines cover proprietary content developed by manufacturers as well as third-party content disseminated via social media channels.
Read more about Mexican Regulators Set Digital Advertising Recommendations for Medical Devices...

Mexican Regulators Overhaul Medical Device, IVD Classification Rules

EMERGO SUMMARY OF KEY POINTS:

  • Mexican regulators have updated classification and related requirements for medical device and IVD registrants.
  • COFEPRIS has up-classified most IVD products and clarified definitions pertaining to medical device regulations.
  • COFEPRIS first announced these planned changes in early 2017.
Read more about Mexican Regulators Overhaul Medical Device, IVD Classification Rules...

Mexico: New Allowances for Drug Registration Renewals Likely to Apply to Medical Devices, Too

EMERGO SUMMARY OF KEY POINTS:

  • Mexican regulators now allow drug registrants to submit product modification and renewal applications simultaneously.
  • It is anticipated that COFEPRIS will eventually extend this allowance to medical device registrants.
  • If extended to medical devices, the COFEPRIS allowance would streamline manufacturers’ obligations in order to obtain registration renewals and approvals for product changes.
Read more about Mexico: New Allowances for Drug Registration Renewals Likely to Apply to Medical Devices, Too...

Revisions to Mexico’s Medical Device Regulations under Consideration for 2018

EMERGO SUMMARY OF KEY POINTS:

  • Mexican regulators have proposed changes to classification, grouping and other processes for medical devices requiring COFEPRIS registration.
  • Changes would take effect in January 2018 at the earliest.
  • All changes must be published in Mexico’s Official Diary before full implementation.
Read more about Revisions to Mexico’s Medical Device Regulations under Consideration for 2018...

Mexican Regulators Allow Greater Third Party Reviewer Involvement for Stalled Medical Device Applications

EMERGO SUMMARY OF KEY POINTS:

  • COFEPRIS has communicated plans to expand Third Party Reviewer (TPR) access to Mexico registrations that have stalled under the standard premarket review system.
  • TPRs may obtain stalled COFEPRIS premarket registrations, review them and then submit them back to the regulator for final approval.
  • The new allowance covers standard-route registrations, modifications and renewals, but excludes applications submitted under Mexico’s equivalency registration route.
Read more about Mexican Regulators Allow Greater Third Party Reviewer Involvement for Stalled Medical Device Applications...

Mexico’s COFEPRIS Provides Glimpse of Medical Device Regulatory Activities

EMERGO SUMMARY OF KEY POINTS

  • COFEPRIS plans for 2017 include expanding the list of products exempted from Mexican medical device regulations.
  • The Mexican Third Party Reviewer (TPR) program is becoming a more viable market pathway for medical device registrants.
  • Equivalency route approvals utilizing US, Canadian and/or Japanese registrations are also on the uptick.
Read more about Mexico’s COFEPRIS Provides Glimpse of Medical Device Regulatory Activities...

Mexican Regulators Boosting Third-Party Review Process for Medical Devices

Mexico’s medical device market regulator COFEPRIS has slated efforts to improve its third-party review (TPR) process and reduce registration timeframes for 2016.

Read more about Mexican Regulators Boosting Third-Party Review Process for Medical Devices...

The medical devices market in Latin America

Most people don’t realize it, but taken together, the major Latin American countries—Brazil, Mexico, Colombia, Chile, and Argentina—represent the third largest economy in the world, with a healthcare expenditure comparable to China and India. Their combined GDP exceeds $4.25 trillion and the medical device industry has grown into a significant combined market. It’s no surprise that medical device companies have their eye on Latin America.

Starting points: Mexico & Brazil

Read more about The medical devices market in Latin America...

When COFEPRIS will Accept ISO 13485 in Lieu of EIRs for US Devices Seeking Expedited Mexico Registration

Emergo consultants in Mexico City have learned additional information regarding COFEPRIS requirements for US FDA-cleared or approved devices undergoing expedited registration in Mexico.

Read more about When COFEPRIS will Accept ISO 13485 in Lieu of EIRs for US Devices Seeking Expedited Mexico Registration...

Mexico to Introduce New Class for Low-risk Medical Devices

Mexican medical device regulator COFEPRIS plans to establish a new device category, Class 1A, for nearly 100 products currently exempt from registration requirements.

Items on the list include tongue depressors, nasal aspirators, umbilical tapes and clamps, gauze, compression bandage systems and bandages.  

Read more about Mexico to Introduce New Class for Low-risk Medical Devices...

Read by 50,000+ device professionals worldwide.

Stay updated on changes to global medical device regulations.RADAR